Implanted PNS for Shoulder Pain in Stroke
Phase: NA
Conditions: Stroke, Shoulder Pain
Sponsor: MetroHealth Medical Center

Protocol: Peripheral Nerve Stimulation for Shoulder Pain: Dose Response    
ID: IRB16-00510    
NCT02928055 
Document Date: 12/18/2020 

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8.0 Methods and Procedures I:
8.1 
Will this research involve the following Social-Behavioral Procedures: 
Name
Psychological Testing
Surveys/Questionnaires
Check all that apply.
8.2
Will this research involved any of the following Medical
Procedures/Considerations: 
Name
Collection of Biohazardous Substances
Study of Human Biological Materials (i.e. Urine Collection)
Investigation/Approved Devices
Study of Existing Data
Medical Tests, Comparisons, Evaluations
Clinical Assessments (EEG, EKG, SCID, etc.)
Venipuncture (Blood Draw)
Use of investigational devices
Psychological testing
Check all that apply.
8.3 
Identify Data Collection types for this study: 
Name
Audio-Recording/Video-Recording/Photographs
Chart Review - Prospective
Existing/Retrospective Data/Specimens
Interviews, questionnaires or psychological tests
Check all that apply.
Note if you are doing,
recordings, Video-
Recording/Photographs then
subjects will need to sign the
MetroHealth Audio-Video
Consent form. See the IRB
Forms and Templates.
View: 08-01 Methods and Procedures II
8.1 Methods and Procedures II:
8.4 
* Please specify in detail the methods and procedures that are involved in
this research: 
Study Summary: This is a pilot RCT to explore the role of muscle contraction as a
mechanism produced by peripheral nerve stimulation (PNS) to reduce hemiplegic
shoulder pain (HSP). Thirty subjects will enroll and receive a 3-week course of
percutaneous IM PNS at one of 3 doses. Subjects will be randomized to receive the
standard IM PNS treatment (15,120 total contractions), IM PNS at half the standard
dose (7,560 total contractions), or IM PNS at 1.5 times the standard dose (22,680
total contractions). Dose will be controlled by differing the stimulation time per day
(3h, 6h, or 9h) while keeping constant the duty cycle of stimulation. Subjects will be
followed for 12 weeks after treatment. 
Baseline Variables and Randomization: Baseline data will be collected so that the
balance of covariates across the three groups can be evaluated. Each participant will
be characterized with respect to demographics, comorbidities, and medication use.
If this field is not completed your
protocol will not be reviewed. Do
not enter N/A. Please describe
what methods and procedures
will be involved in this research.
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
NCT02928055

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Study outcome measures (see Outcomes Assessment) will be administered to
establish baseline levels. Participants are assigned to treatment groups using an
adaptive randomization algorithm [76-78] to minimize group imbalances on key
patient characteristics: baseline pain (>6 or <=6) [79], duration of pain (>=18
months or <18 months) [5], and age (>=55 years or <55 years). For each
assignment, the algorithm calculates the balance of these variables across the
groups and makes an assignment that would result in greater balance in the
variables across groups. 
Percutaneous PNS System: The Sprint PNS System (SPR Therapeutics, Cleveland,
OH), also known as the Smartpatch System, will be used to deliver the PNS therapy.
The System consists of a small external stimulator, percutaneous lead, and pad. The
external stimulator “snaps” on to the pad. The pad has an embedded power source
for the System but also serves as the anode. The pad is replaced regularly based on
treatment parameters, allowing the investigative team to prescribe the total dosage
based upon the number of pads. The single-channel stimulator outputs a biphasic
current waveform with current pulse parameter ranges that are suitable for PNS.
These electrodes have been used extensively to deliver percutaneous PNS to
shoulder muscles. [6-12, 62, 71] 
Lead Placement Procedure: The procedure will be performed under a sterile
condition. The location and depth of the electrode implant site are determined by
monopolar needle stimulation with demonstration of strong contraction of both the
middle and posterior deltoid muscles. [6, 9, 62, 70] The introducer loaded with the
lead is inserted perpendicular to the skin surface and advanced to the depth (3-4
cm) defined by the monopolar test stimulation. The introducer is then withdrawn
with the electrode retained in the muscle by a barb at its tip.
PNS Treatment Protocol: After one week for lead stabilization [80], the Sprint PNS
System will be programmed for stimulation. Based on over 30-yrs of experience, the
Cleveland FES Center established parameters for safe and effective delivery of PNS
(pulse frequency = 12 Hz; pulse amplitude = 20 mA; pulse duration = 5-200 usec
(set by clinician); duty cycle = 5-sec ramp-up, 10-sec plateau, 5-sec ramp down, 10
sec off; daily stim time (randomized) = 3, 6, 9 hrs/day; total contraction dose
(randomized) = 7560, 15120, 22680 contractions). [81] These parameters provide
strong fused comfortable muscle contraction with minimal fatigue. [6-12, 49, 62,
71,82-84] Stimulation frequency and amplitude are fixed. The pulse duration is set
to produce strong, comfortable contraction of both the middle and posterior deltoids.
A balanced biphasic waveform allows an equal amount of current to flow in either
phase, creating a safe net zero charge. [85] In this dose-response study, participants
receive 3h, 6h, or 9h of stimulation each day. The stimulator keeps an electronic log
for compliance monitoring. 
Electrode and Electrode Site Surveillance and Electrode Removal: All caregivers and
participants will be trained in the assessment of electrode site and the daily
placement of the Sprint Pad. The caregiver conducts daily inspections to detect
complications. The nurse coordinator inspects the site for infection and performs
motor/sensory threshold testing for lead migration and lead integrity, respectively, at
the following times: within 48-72 hrs of lead placement, at the beginning of PNS
treatment, and at the end of treatment. Inspection and testing of motor/sensory
thresholds and impedance may also occur anytime during the 3-wk PNS treatment
period as deemed necessary. At the end of treatment, the electrode is removed by
gently pulling on the external portion. All participants undergo radiographic
surveillance for retained electrode fragments. 
Outcomes Assessment: The primary outcome measure is the worst pain in the prior
7-days (BPI SF-3). Secondary measures include pain interference with ADLs (BPI SF-
9); QoL (SF-36); shoulder impairment (isometric voluntary abduction shoulder
torque (IVAST), shoulder kinematic analysis, optional Fugl-Meyer Motor Assessment
(upper limb)); and measures of central sensitization (mechanical pain thresholds for
hyperalgesia, optional pinprick pain thresholds for hyperalgesia, temporal summation
of repetitive pin-prick stimuli). Other optional measures include tactile/touch,
vibration and thermal/thermal pain detection thresholds, temporal summation of
repetitive thermal stimuli, and Conditioned Pain Modulation (CPM). Details for each
measure are presented below. The outcomes are administered face-to-face in a
blinded manner.
Brief Pain Inventory SF-3: The BPI has excellent psychometrics [86-92] and is
recommended by the IMMPACT group for the assessment of pain in clinical trials.
[75] The developers of the BPI recommend BPI SF-3, the “pain worst” rating, as the
primary response metric. The question asks participants to rate their worst pain in
the prior 7-d on a 0 to 10 NRS, where “0” indicates “No pain” and “10” indicates
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
NCT02928055

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“Pain as bad as you can imagine.” In order to gain a more comprehensive
assessment of participants’ pain experience, daily least pain (BPI SF-4), daily
average pain (BPI SF-5) and daily present pain (BPI SF-6) after morning ADLs are
also collected. To analyze successful treatment, short-term responders will be
defined as those who have a clinically meaningful 30% reduction of pain [72] at end
of treatment. Long-term responders will be those who continue to have 30%
reduction at weeks 8 and 12. The investigative team has extensive experience with
the BPI. [2, 5, 8, 10, 11, 13, 70, 71, 93, 94] 
Pain interference with ADLs – BPI SF-9: BPI SF-9 specifically evaluates the impact of
pain on ADL performance within 7 domains of daily activity over a 7-day period:
general activity, mood, walking ability, normal work, relations with other people,
sleep and enjoyment of life on a 0-10 NRS, where 0 indicates “does not interfere”
and 10 indicates “completely interferes.” [124] The BPI SF-9 score is the average of
the scores for the 7 domains. Psychometrics have been evaluated as part of the BPI
battery. [86-89] BPI SF-9 has been used to evaluate the impact of percutaneous PNS
mediated pain reduction on ADLs. [6, 8, 11, 13, 62, 70] 
QoL – SF 36: SF-36 is a health related QoL measure that assesses physical
functioning, role limitation because of physical health problems, bodily pain, social
functioning, general mental health, role limitations because of emotional problems,
vitality (energy/fatigue), and general health perception. [125] It is the only reliable
and valid measure previously used to assess change in QoL associated with the
treatment of shoulder pain with PNS. [6, 9, 13, 71] 
Isometric Voluntary Abduction Shoulder Torque (IVAST): IVAST is an objective
predictor of strength which is an important factor in ability to complete functional
tasks in older adults. [195] IVAST will be measured in an established protocol [96]
with a Biodex Biomechanical Measurement System (Biodex Medical Systems, Shirley,
NY). Participants will be seated and fastened securely with the abduction axis of the
shoulder aligned with the rotational axis of the dynamometer. The arm will be
attached to the dynamometer by a strap just above the elbow. The arm will be held
at 30 degrees of shoulder abduction and neutral rotation. Participants will be asked
to abduct their arm in response to an audio tone. The duration of the audio tone
randomly varies between 3 and 5 seconds to prevent the anticipation of the start or
end of the cue. The average torque during the last second of the audio tone will be
calculated and those values will be averaged over three trials, with 1-minute rest
between trials. Abduction torque measurement via Biodex shows high intra – and
interrater reliability. [97] 
Shoulder Kinematic Analysis: An objective measure of glenohumeral and scapular
range of motion will be obtained using an optical tracking system (Optotrack Certus,
NDI Measurement Science, Ontario, Canada) during the performance of passive and
active pain-free shoulder abduction rotation while seated. Active LED markers will be
mounted on the sternum, scapula, upper arm, and forearm. Digitization of bony
landmarks on the thorax, scapula, and humerus permit transformation of sensor
data into local segment coordinates according to standard protocol. Custom software
will be used to extract angular data from the sensors and calculations will be made
following the recommendations of the International Society of Biomechanics,
Shoulder Group. [98] The extracted angular data includes: 1) peak humeral
elevation and 2) Peak scapular tilt. Analysis in post-stroke shoulders is a reliable and
valid measure of impairment. [99, 100] 
Fugl-Meyer Motor Assessment, upper limb (optional): If PNS reduces HSP by
reducing motor impairment, then Fugl-Meyer Motor Assessment (FMA) scores should
improve. The FMA was derived from the Brunnstrom Stages [126] of post-stroke
motor recovery. Each test element will be graded on a 3-point ordinal scale and
summed to provide a maximum upper limb score of 66. Reliability and validity have
been demonstrated. [127-129] The FMA will be administered while the subject was
seated. 
Mechanical Pain Thresholds for Hyperalgesia: The PPTs will be measured with a hand-
held Wagner Instruments FPIX Digital dynamometer (Wagner Instruments,
Greenwich, CT) with 1 sq-cm rubber tip. The PPT is defined as the amount of force
(applied at a rate of 1 kg per second) required to produce a sensation of pain distinct
from pressure or discomfort. The 3 sites are the mid-belly of the deltoid muscle of
the affected and non-affected limb and the mid-belly of the tibialis anterior of the
contralateral limb. Three readings will be averaged at each site. The reliability and
validity of the pressure algometry to evaluate deep somatic tissue sensitivity have
been demonstrated [101-103], and the method has been used to evaluate central
sensitization in numerous pain conditions [104-114], including chronic shoulder pain.
[19, 20] 
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
NCT02928055

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Pinprick pain thresholds for Hyperalgesia (optional): Pinprick thresholds will be
measured at the same sites using weighted pinprick stimuli that exert forces of 8,
16, 32, 64, 128, 256, and 512 mN (PinPrick Stimulators, MRC Systems GmbH,
Heidelberg). [115, 116] The stimulators will be applied at a rate of 2 s on, 2 s off in
an ascending order until the first percept of sharpness is reached. The final threshold
will be the geometric mean of five series of ascending and descending stimuli.
Pinprick pain threshold has been used to evaluate central sensitization in numerous
conditions [117-120], including chronic shoulder pain. [19, 20] 
The perceived magnitude of a single pinprick stimulus will be compared with that of a
train of 10 pinprick stimuli of the same force (256mN OR 512mN) repeated at 1/s
rate at the same sites. The use of the larger stimuli will be made if, when presented
at the first test site, the perceived pain rating is “0” for the lesser of the two. Thus, a
greater differentiation of response may be possible, but will not present a significant
discomfort to the subject. In all tests, the subject can stop the testing procedures.
Single pinprick stimuli will be alternated with a train of 10 stimuli until both are done
at three different sites: affected shoulder, unaffected shoulder, and unaffected tibialis
anterior (lower leg). The mean pain rating of trains divided by the mean pain rating
to single stimuli will be calculated as wind-up ratio (WUR). [116] 
Several other outcomes measures also will be optional and may not be completed if
the testing is found to take an excessive amount of time or if the subject is, for any
reason, unable or unwilling to complete all of the testing. These include: 
Tactile/touch detection thresholds will be measured using stimulus presentations of
graded TouchTest von Frey monofilaments (North Coast Medical) at each test site.
Using the ascending method of limits, the lowest force monofilament will be
presented to the subject who will respond as to whether or not he/she felt the
stimulus presentation, and increasing forces will be presented until the subject
responds that he/she felt the stimulus. The second series of stimulus presentations
will use the descending method of limits in which a stimulus force that is above
threshold level will be presented and decreasing levels of force will continue to be
presented until the subject indicates that he/she can no longer feel the stimulus. A
second ascending and then a second descending series of stimulus presentations will
occur, so that four estimates of threshold will be obtained at each site.  
Vibration detection thresholds will be measured using the VSA 3000 Vibratory
Sensory Analyzer component of a TSA-II Neurosensory Analyzer (Medoc, LTD;
cleared commercially under K922052). The flat probe tip (1.22 sq cm) of the
vibratory device will be held lightly against the skin, and the amplitude of the
(100Hz) vibration will slowly increase until the subject reports that he/she can feel
the vibration. Three trials will be performed at each test site. 
Thermal detection and thermal pain function measures will be performed also using
the TSA-II Neurosensory Analyzer. Thermal stimuli will be delivered via a thermal
probe with contact area between 2.5 sq cm and 9 sq cm. The probe will be held
lightly against the skin as the temperature increases (for warm detection and hot
pain thresholds) or decreases (for cool detection and cold pain thresholds) from a
baseline temperature that approximately matches the neutral skin surface
temperature (32ºC). Subjects will be instructed to verbally respond when the desired
sensation is reached. (For example, during cool detection threshold trials, subjects
will be instructed that the temperature will slowly change from a neutral
temperature, and that they should tell us as soon as they detect any change in
temperature at the test site. For cold pain threshold trials, subjects will be told that
the temperature will slowly change from a neutral temperature, and that they should
tell us as soon as they feel the sensation increase to a level that they would call
painful.) Each type of sensation threshold (cool detection, warm detection, cold pain,
hot pain) will be measured three times at each test site. 
Temporal Summation of repetitive thermal stimuli will be assessed using the TSA-II
Neurosensory Analyzer in a way comparable to Temporal Summation of repetitive
pin-prick stimuli described earlier. The perceived magnitude of a single thermal
stimulus will be compared with that of a train of 10 thermal stimuli of the same
magnitude repeated at a 1/s rate at the same sites. The mean pain rating of trains
divided by the mean pain rating of single stimuli will be calculated as wind-up ratio
(WUR). 
Conditioned Pain Modulation (CPM) is measured using a diffuse noxious inhibitory
control (DNIC) protocol and analyzed through established methods. [121] The “test-
stimulus” is a 7-sec presentation of a thermal noxious stimulus (between 43-49ºC)
to the volar forearm of the nonparetic limb, and the “conditioning stimulus” is the
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
NCT02928055

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immersion of the nonparetic foot/distal leg into a cold-water bath (12ºC) for 60 sec.
Pain intensity ratings of the test stimulus occur prior to the conditioning stimulus
(“baseline” pain rating), and 40 sec after the conditioning stimulus is initiated
(“conditioned” pain rating). The extent of CPM is calculated by subtracting the
conditioned pain rating from the baseline pain rating of the test stimulus. [121] 
Other: Five other surveys also are collected once each for either eligibility
determination or potential correlative data analysis. These are the Mini Mental State
Exam (MMSE), the Beck Depression Inventory (BDI), the Pain Catastrophizing Scale
(PCS), the Fear Avoidance Beliefs Questionnaire (FABQ) and a Patient Global
Impression of Change (PGIC) Assessment. 
Concomitant Therapies: Participants may not receive additional PT or OT for pain
during the treatment period or during follow-up, but PT or OT for function is
permitted. Similarly, they may not receive any injections, or any other forms of
electrical stimulation, including TENS or surface PNS, to the affected shoulder. Due to
ethical considerations, use of non-opioid and opioid analgesics for pain management
will be allowed. Participants may adjust dosing of these medications, but it is
preferred that they not change or add medications during the protocol. Participants
will maintain their dosage during the week prior to each visit to match the recall
period for assessment of BPI SF-3 and 9. Medication use is monitored via diary. 
8.5
Does this study only involve the use of existing/retrospective
data/specimens? 
No
Check yes or no.
8.6 
Describe in detail the study design also known as the experimental flow.
Include all study procedures a subject will go through, in order of sequence
and timing, including frequency of visits, duration of visits, length of subject
participation etc. Please Note this needs to be written for an educated
person who is not an expert in the field, do not exceed 300 words: 
The duration of each subject's participation will be ~4 months. 
Visit 1 – Consent/Eligibility: Consent form signed; assessed for eligibility per
inclusion/exclusion criteria; MMSE administered; BDI, PCS & FABQ administered;
medical history, demographics, comorbidities, and medication use recorded; blood
drawn for INR (in applicable subjects); pregnancy test (in applicable subjects). (~3.5
hrs) 
Visit 2 – Baseline Outcomes Assessment: Study outcome measures (see Outcomes
Assessment) administered to establish baseline levels. (~4 hrs) 
Visit 3 - Sprint MicroLead (Electrode) Implant Procedure: Testing of muscle response
with Sprint Test Needles; Implantation of percutaneous Sprint MicroLead. Subject
given instructions on care of Lead exit site. Skin checked, subject queried for
medication usage. Randomization to treatment group. Subset of study outcome
measures (questionnaires only) administered. (~2.5 hrs) 
Visit 4 - 48-72 hour Post-Implant Safety Check: Check the Lead exit site within 48-
72 hours of the Implant procedure; dressing changed. (~1 hr) 
Visit 5 - Start of Stimulation: Collection of parameter data; programming of external
stimulator (Sprint Stimulator). Subject given instructions on use of System and care
of Lead exit site. Skin checked, dressing changed, subject queried for medication
usage and adverse events. Subset of study outcome measures (BPI-SF only)
administered. (~2 hrs) 
Phone Call #1 – One week after starting stimulation, subject queried on condition of
Lead exit site, pain, adverse events. (30 min) 
Phone Call #2 – Two weeks after starting stimulation, subject queried on condition of
Lead exit site, pain, adverse events. (30 min) 
Visit 6 - EOT Outcomes Assessment & Explant Procedure: Study outcome measures
administered (4 weeks post-Implant). PGIC administered. Skin checked, subject
queried for medication usage and adverse events. Lead Removed. X-rays performed
(may be done as separate clinical visit). (~4.5 hrs) 
Phone Call #3 - 1 week Post-Explant Safety Check: Subject queried on condition of
Lead exit site. (15 min) 
Visit 7 - 8-wk Outcomes Assessment: Subset of study outcome measures
This is also known as NIH
Experimental Procedure
section or Clinical Trial
Procedure/Experimental Flow
section. Do not just attach
documents in response to this
question you must do a study
design summary for IRB
Review.
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
NCT02928055

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(questionnaires only) administered (8 weeks post-Implant (4 weeks post-EOT)).
Subject queried for medication usage. (~1 hr) 
Visit 8 - 12-wk Outcomes Assessment: Subset of study outcome measures
(questionnaires only) administered (12 weeks post-Implant (8 weeks post-EOT)).
Subject queried for medication usage. (~1 hr) 
Visit 9 - 16-wk Outcomes Assessment: Study outcome measures administered (16
weeks post-Implant (12 weeks post-EOT)). Subject queried for medication usage.
(~4 hrs) 
Provision for lead replacement: If, in the judgement of the Investigator, the Sprint
MicroLead becomes significantly displaced or fully dislodged, it is possible that the
Investigator may elect to place another lead which would require an unscheduled
visit and additional 48-72 hour safety check. Other visits may be repeated as
appropriate. 
Unscheduled Visits are conducted if/as needed. 
8.7 
Please attach study design/subject visit schedule here: 
Name
Description
PNS Dose for HSP Visit Schedule Table (06-14-2017) | History
If you have an
electronic schedule of study visits
and/or procedures please attach
here.
View: 09-00 Inclusion/Exclusion Criteria
9.0 Inclusion/Exclusion Criteria:
9.1 
What are the inclusion criteria? Put this information in bullet form: 
• shoulder pain localized to the glenohumeral joint, subacromial area or deltoid
insertion associated with: a) rest; b) passive abduction or external rotation range of
motion (ROM); c) active abduction ROM; or, d) manual palpation;
• shoulder pain onset or worsening after the most recent stroke;
• weakness of shoulder abductors (≤4/5 on MRC if isolated movement is present);
• ≥ 21-yrs old; < 90-yrs old;
• time of stroke ≥ 3-mo;
• duration of HSP ≥3-mo;
• HSP with moderate to severe pain (BPI SF-3 ≥ 4);
• cognitive and communication ability to fulfill study requirements (cognitive ability
based upon a score of ≥24 on the Mini Mental Status Exam (MMSE));
• availability of reliable adult who can assist with study procedures if necessary;
• willing and able to report shoulder pain and other conditions and complete study
visits throughout the 4 month study period.
Please list inclusion criteria.
9.2
What are exclusion criteria? Put this information in bullet form: 
• joint or overlying skin infection or history of recurrent skin infections;
• insensate skin;
• need to take > 1 opioid and > 1 nonopioid analgesic medication for HSP;
• regular intake of pain medications for another chronic pain;
• botox injection or subacromial steroid injections to the shoulder within the
past 12 wks;
• receiving OT or PT for HSP;
• bleeding disorder or INR > 3.0;
• sensitivity to skin surface electrodes and/or medical-grade adhesives, gels,
tapes;
• medical instability;
• pregnancy;
• uncontrolled seizures (>1/mo for 6-mo);
• history of cardiac arrhythmia with hemodynamic instability;
• history of lidocaine allergy;
• history of Parkinson’s disease, SCI, TBI, MS, or ipsilateral UE lower motor
neuron lesion;
• history of complex regional pain syndrome, myofacial pain syndrome, other
pain conditions (investigator discretion);
• cardiac pacemaker or other implanted electronic device;
• history of valvular heart disease (artificial valves, requiring antibiotics for
procedures, etc.);
• severely impaired communication;
• history of compromised immune system (i.e., recently or actively taking
immunosuppressive therapies, AIDS) congenital immunodeficiency, or any
other cause for compromised immune system with which participation would
pose excessive risk.
Please list exclusion criteria.
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
NCT02928055

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9.3 
How will subject eligibility be determined and by whom? 
Subject eligibility will be initially assessed by the study coordinator and will be
confirmed and reviewed by the Investigator. Eligibility will be determined from: 
• review of medical history available in the chart;
• completion of the Brief Pain Inventory Short Form (to confirm baseline degree of
pain of ≥ 4);
• bloodwork (to confirm suitable coagulation levels in patients on anticoagulants) or
pregnancy urine or serum test in applicable female subjects;
• physical examination of shoulder.
 
Please describe in detail.
9.4
Will you exclude women and minorities, or persons under 21 from
enrollment?
Yes  
Check yes or no.
9.5
If yes, which groups are you excluding? Provide justification for your
decision. 
Pregnant women: Pregnant women will be excluded since the effect of electrical
stimulation on the fetus is not known. 
Persons under 21: Children are excluded based on scientific considerations as they
represent a fundamentally different population with chronic post-stroke shoulder pain
etiologies and substantially different from the adult population. Individuals that are at
least 21 years of age possess additional maturity beyond those that are 18. The study
involves the use of an external stimulator and requires the maintenance of a
percutaneous exit site. As such, we believe that this additional level of maturity is a
valid reason to extend the minimum age of enrollment to 21. 
List groups to be excluded then
provide justification.
9.6
Attach Documents: 
Name
Description
There are no items to display
If you are unable to fit your
answers in the text boxes
provided please attach as a
word document.
View: 10-00 Risk/Benefits
10.0 Assessment of Risk I:
10.1
Identify and distinguish between those procedures that are standard versus
those that are experimental. Include the frequency and duration of each
activity and the total length of subject participation: 
• Physical Exam and Range of Motion of shoulder (standard): A physical exam and
range of motion assessment is standard for patients with shoulder pain and will be
done at Visit 1. The shoulder will be physically inspected during each visit.
• Collection of bloodwork (standard): The blood test (INR score) is standard for
patients taking anticoagulants. This test will be collected in applicable subjects at
Visit 1. A standard pregnancy test will also be administered in applicable subjects and
can either be urine or serum pregnancy test.
• EMG needle electrode testing (experimental ): EMG needles are commonly used to
evaluate muscle physiology and strength of muscle contractions. In this study,
however, EMG needle (Sprint Test Needle) testing will be used to deliver test
stimulation during the lead implant procedure.
• Placement of Percutaneous Fine Wire Intramuscular Lead (experimental): The
placement of the lead during the lead implant procedure and the use of stimulation
during the treatment phase are experimental. Local anesthetic will be used.
• X-rays (standard): One 2-view (AP/Lateral and Scapular Y) shoulder x-ray will be
conducted following the removal (explant) of the electrode lead, to determine and
document the presence of any retained fragments.
• Collection of surveys and questionnaires - BPI, SF-36 (standard): These surveys
are used for research, but are commonly used in pain patients. These surveys will be
collected as defined elsewhere in this protocol for Outcomes Assessments Visits; the
BPI additionally is collected at the Start of Stimulation Visit. The Mini Mental Status
Exam (MMSE, also standard) will be collected at Visit 1. The BDI and PCS (also
standard) are used for research, but are commonly used in pain patients. They will
be collected at Visit 1. The FABQ (experimental) will be collected at Visit 1. The PGIC
(experimental) will be collected at Visit 6.
• Fugl-Meyer Motor Assessment (upper limb): The FMA (standard) will be used as
defined elsewhere in this protocol for Outcomes Assessments Visits.
• Other outcomes measures (experimental): Isometric voluntary abduction shoulder
torque (IVAST), shoulder kinematic analysis, and measures of central sensitization
(mechanical pain thresholds for hyperalgesia, pinprick pain thresholds for
hyperalgesia, temporal summation of repetitive pin-prick stimuli) are used for
research but some also are used in clinical practice as well. They will be used as
defined elsewhere in this protocol for Outcomes Assessments Visits. Optional
measures include tactile/touch, vibration and thermal/thermal pain detection
thresholds, temporal summation of repetitive thermal stimuli, and Conditioned Pain
Please distinguish between
those procedures that are
standard versus those that are
experimental. Describe in detail
all experimental procedures.
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Modulation (CPM). They also are used for research but some also are used in clinical
practice as well. 
10.2
Describe any therapeutic alternatives to the research that may exist. How
are they different from those procedures that subjects would normally
undergo?  
Numerous interventions exist for the treatment of shoulder pain following
stroke. This is due to the large number of possible etiologies, the diversity of
clinicians that treat stroke patients, and the lack of consensus regarding a
standard of care. None of the following interventions have been shown to
reduce pain reliably in randomized controlled trials. 
Slings and other supports: Arm slings and other mechanical supports, such
as wheelchair trays, are often used to support the forearm and distribute its
weight to one or both shoulders in an effort to prevent or reduce
subluxation. Although slings may reduce subluxation, they often fail to
reduce shoulder pain as subluxation recurs once they are removed and may
slow rehabilitation by reducing arm mobility. 
Strapping: Strapping is the application of non-stretch tape to the affected
limb to support the glenohumeral joint while allowing free movement of the
arm. In a randomized controlled study of 33 patients, those who received
strapping reported reduced average pain compared to those who received
no therapy (inactive control group). However, strapping fails to produce a
significant benefit compared to active control groups, who received either
sham strapping or standard physiotherapy without strapping. In addition,
the tapes must be replaced at least every three days, and skin irritation is
common. 
Local Injection Techniques: Corticosteroid injections address pain by
treating inflammation. Approximately 50% of clinicians who treat patients
with poststroke shoulder pain believe that steroid injections are effective.
However, there are only two randomized controlled trials of corticosteroid
injections for the treatment of post-stroke shoulder pain and they have
mixed results. A recent trial of subacromial injections reported significant
benefit over placebo. However, an earlier placebo controlled trial of intra-
articular injections showed no benefit. Post-stroke shoulder pain has a
variety of possible etiologies and does not always arise from inflammation,
explaining why steroid injections do not consistently outperform placebo in
stroke patients. In addition to uncertain efficacy, repeat corticosteroid
injections are associated with frequent adverse events, making them a poor
treatment option. 
Botulinum toxin causes local paresis of muscles by blocking cholinergic
transmission at the neuromuscular junction. It has been widely used to treat
spasticity and some data suggest that it may also help to relieve pain. Six of
nine patients in a small uncontrolled study receiving an injection of
botulinum toxin to the affected limb reported pain reduction. However, the
effect of botulinum toxin is known to diminish after 3-4 months, making
repeated injections necessary. Little data exist regarding the repeated use
of botulinum toxin for shoulder pain relief. 
Oral analgesic medications: The use of opioid and nonopioid analgesics,
including nonsteroidal anti-inflammatory drugs (NSAIDs) to manage
shoulder pain is common practice. Unfortunately, extended use of opioids
can lead to dependence and side effects such as headache, skin rash,
dizziness, and gastrointestinal symptoms. Though NSAIDs may reduce
shoulder pain in the general population, their efficacy has not been
demonstrated in the stroke population. 
Therapeutic exercises: Therapeutic exercises under the supervision of a
trained professional are generally considered to be an important part of
poststroke rehabilitation. Although they prevent immobility and improve the
range of motion (ROM) of the hemiplegic arm, studies have found that some
exercises, such as the use of an overhead pulley, can cause soft tissue
damage and thereby worsen shoulder pain. In fact, exercises are generally
associated with a worsening of pain or no change, rather than an
improvement. In a study investigating static positional stretches, the
treatment group showed increasing levels of pain. 
Acupuncture/Electroacupuncture: Acupuncture has been used for centuries
to treat various types of pain and is believed to improve cutaneous and
Describe any therapeutic
alternatives. Can subjects
receive this drug or device
outside of a research study?  
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muscle blood flow and to increase pain thresholds. Electroacupuncture, a
therapy in which traditional acupuncture needles are used in conjunction
with electrical stimulation, has been evaluated as a therapy for shoulder
pain in post-stroke subjects in a randomized study comparing
electroacupuncture plus occupational/physical therapy to therapy alone.
Although statistically significant improvements in pain reported via a Visual
Analog Scale were observed in the treatment group, the study did not follow
the group beyond the conclusion of the treatment. Thus it is not clear how
often the therapy must be reapplied. In addition, electroacupuncture
requires repeated clinic visits (at least 3 visits per week for 1 month).
Traditional acupuncture has also been evaluated as a treatment for shoulder
pain; however subjects in these studies had non-stroke shoulder pain
etiologies. 
Surface electrical stimulation: Surface electrical stimulation uses skin
surface electrodes applied to the shoulder to deliver stimulation from an
external stimulator. Baker and Parker published the first results from a
randomized controlled trial of surface electrical stimulation for the
treatment of poststroke shoulder pain. The authors found a treatment effect
for subluxation but inconclusive results regarding pain relief. The
investigators of a later study hoped to obtain more conclusive results than
Baker and Parker by enrolling a larger population of 120 and following the
subjects for two years. Pain was noted as present or absent at rest during
passive motion and during active motion. Subjects were also asked to rate
their pain using a visual analogue scale (VAS). For a subject to be classified
as having no pain, all four variables had to be negative. A significantly
higher proportion of subjects receiving electrical stimulation had no pain at
3, 6, 12, and 24 months compared to the control group (80.7% vs. 55.1%,
p<0.01). The treatment subjects also showed a greater reduction in
subluxation and a significant improvement in the recovery of arm motion.  
The results of four additional studies investigating surface electrical
stimulation are summarized in a Cochrane review. Although the authors
found a significant improvement in pain-free range of motion (ROM) in the
treatment groups, the data did not support a significant reduction in pain
intensity or incidence. The authors concluded that larger randomized
controlled studies would be necessary to fully examine the effects of
electrical stimulation in the post-stroke shoulder pain population. 
Another literature review including six trials found that electrical
stimulation paired with conventional therapy is not superior to conventional
therapy alone for pain prevention. However, they noted that this may be due
to the indirect way in which most studies measured pain (as “pain-free
range of shoulder external rotation”). When pain was measured directly,
using a VAS, electrical stimulation was found to be more effective in
preventing pain than conventional therapy. 
The results regarding the efficacy of surface electrical stimulation as a
treatment for post-stroke shoulder pain have been promising, leading to its
recommendation by several recently published guidelines. In addition, a
literature review proposed that surface electrical stimulation combined with
gentle clinician guided exercises should be considered the “best practice”
for acute stroke survivors. However, several authors have noted that even
with further evidence of the efficacy of surface electrical stimulation, it is
unlikely that it will ever be the standard of care due to the discomfort
caused by stimulation of cutaneous pain receptors, the potential for skin
irritation under multiple surface electrodes, the need for skilled personnel to
place the surface electrodes on a daily basis, and muscle fatigue that
commonly occurs due to the high frequency of stimulation. Baker and Parker
noted that either an implantable or a percutaneous system would have to be
developed before electrical stimulation could become the preferred
treatment. For these reasons, researchers have turned their attention to the
use of intramuscular electrical stimulation. 
bion® microstimulator (investigational): Due to the effectiveness of
electrical stimulation but the difficulties associated with surface electrical
stimulation, researchers have begun to investigate direct muscle and nerve
stimulation. The bion® microstimulator used by Bioness, Inc. (Valencia, CA),
is currently being investigated for the treatment of post-stroke shoulder
pain and subluxation. Although the bion has technical advantages, including
its small size and self-contained electrode, it also suffers from considerable
disadvantages. First, the device does not utilize a trial stage to evaluate
whether a candidate is likely to experience pain relief from long term use
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prior to implantation. Second, implantation of the bion requires fluoroscopy
and precise placement in close proximity to the deep axillary nerve trunk.
Third, the device must be recharged daily using a large, stationary charging
apparatus, to which the patient must be tethered during the recharging
session. In addition, the bion’s extraction requires open surgery. Finally, the
bion requires precise placement due to its bipolar configuration, as the
stimulus current density (and efficiency of nerve recruitment) drops off
rapidly with distance from the target nerve. Even a small migration of the
bion could significantly diminish its effectiveness. Data regarding the safe
and effective use of the bion for post-stroke shoulder pain have not yet been
published. 
10.3 
What are the outcome variables and how will they be analyzed? What are
the statistical and analytical methods that will be used? Note this section
can be copied from the NIH Grant Application or from the Statistical and
Analytical Methods section of the industry trial protocol. 
See 8.4 and attachment below. 
Define outcomes and describe
data analysis, please include a
power calculation.
 10.4
If the above requested information does not fit in the text box please attach
a word document here: 
Name
Description
Outcomes Measures and Data Analysis | History
If the  requested information
does not fit in the text box
please attach a word
document.
View: 10-01 Risk/Benefits
10.1 Assessment of Risk II:
10.5
List and quantitate the risks involved for each experimental procedure in
bullet form. Identify risks as common (greater than 10%) uncommon
(greater than 1% up to and including 10 %) rare (1% or less). This must
match the risks listed in the Consent Form: 
1) Risks associated with needle insertion for Sprint MicroLead placement
There are minor risks associated with inserting a Lead through the skin
with a needle. These risks are similar to the risks of any needle injection
including the possibilities of puncturing a blood vessel, irritating a nerve,
and temporary bruising or pain at the insertion site. The risks of
puncturing a blood vessel and irritating a nerve are uncommon, but the
risks of temporary bruising and pain at the insertion site are common. 
Some participants may experience a vasovagal (“fainting”) response due
to the discomfort or anxiety associated with of the procedure, especially
among those with prior history of “fainting.” This risk is rare and may be
associated with symptoms of lightheadedness, dizziness and or diaphoresis
with concomitant reduction in blood pressure and heart rate. For those
with prior history of “fainting” the procedure will be performed with the
subject in the lateral decubitus position. 
To minimize the risks associated with percutaneously placing fine wire
leads, only appropriately trained physician investigators will perform the
procedure. In addition, the risk of excessive bleeding will be reduced by
excluding candidates who are taking warfarin with an INR > 3.0 and by
placing manual pressure on the implantation site until hemostasis is
achieved. Finally, the risk of discomfort during the procedure will be
reduced by the use of an appropriate amount of local anesthetic. 
It is possible that, in some cases, multiple attempts may be required to
achieve appropriate placement of the Lead during the procedure. Each
additional attempt at Lead placement carries the same risks as the initial
attempt described in this section.  
2) Risk of skin irritation, infection, or inflammation at the Sprint MicroLead
exit site
There are risks of leaving a Sprint MicroLead in place for 4 weeks,
including skin irritation, infection, and granuloma formation (mild tissue
inflammation) at the Lead exit site. Symptoms include redness, swelling, or
pain. The risk of skin irritation is common while the risks of infection and
granuloma formation are rare. 
These risks will be minimized by using sterile Leads and thoroughly
Select all that apply.
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he ins 
insertion. The insertion site will be covered with a dressing to keep it clean 
and dry, and the subjects and their caregivers will be instructed to inspect 
the site for signs of infection or irritation regularly and to inform the 
Investigator if they occur. If infection or skin irritation occurs, the 
Investigator will administer an antibiotic and/or remove the Lead. 
Infections are rare and typically resolve after Lead removal and antibiotic 
treatment. 
It should be noted that in a completed clinical trial of percutaneous 
intramuscular electrical stimulation, one patient death occurred. The 
subject did not follow the instructions for the care of the Lead exit site and 
also did not return for his scheduled follow-up visit following electrode 
placement. He developed an electrode related infection and was 
hospitalized. The cause of death is thought to be a myocardial infarction or 
a pulmonary embolus, but the exact cause of the death and its relationship 
to the infection are not known. To mitigate the potential risk of serious 
infection, a 48-72 hour safety check will be performed after the procedure. 
Participants will return to the clinic and the exit site will be evaluated for 
signs of infection. 
3) Risk of the Sprint MicroLead breaking beneath the skin
There is a possibility of a Lead breaking beneath the skin either during the 
course of the study or during the procedure to remove Lead. This risk is 
uncommon. However, when a Lead breaks, one or more Lead fragments 
usually remain in the body. The Investigator will use clinical judgment to 
determine if the removal of such fragments is necessary. Visual inspection 
of the Lead after it has been removed as well as x-rays will be used to 
determine if any Lead fragments remain. The risk associated with the x-
rays is no greater than that associated with conventional clinical x-rays. If 
the Investigator determines a Lead fragment has been retained in the 
body, he/she will determine what is medically required to further evaluate 
and treat this retained fragment. Typically, no treatment is required unless 
there are further sequelae, such as an infection or granuloma, associated 
with the fragment. 
The risk of leaving a Lead fragment is minimized by reducing the amount of 
time the Lead remains implanted and the number of Leads implanted. In 
this protocol, a single Sprint MicroLead will be implanted for just 4 weeks.  
4) Risk of infection associated with retained Sprint MicroLead fragments
A Lead fragment could result in the formation of a granuloma or infection. 
Although the occurrence of a fragment-related infection or granuloma is 
uncommon an infection may require removal of the Lead fragment and/or 
treatment with antibiotics. Investigators at the Cleveland FES Center and 
Case Western Reserve University have over 30 years of experience with 
dozens of research participants and hundreds of implanted leads like those 
used in this study. Infections and granulomas of leads or lead fragments 
have been uncommon, which is attributed to the materials and procedures 
that have been developed as well as the extensive experience of the 
Investigators.. 
5) Risks associated with lead fragment removal
It is possible that a Lead fragment or fragments may be retained in the 
body following removal of the Sprint MicroLead. If the Investigator 
determines that a lead fragment has been retained, the Investigator will 
instruct the subject and his/her caregiver to carefully inspect the Sprint 
MicroLead exit site and the surrounding skin in the weeks subsequent to 
Lead removal. Subjects will be instructed to contact the Investigator if 
there are any signs of pain, redness, swelling, discharge, or the 
appearance of a pimple-like mass (skin abscess). Such signs indicate that 
the fragment has migrated to the skin surface. At that time, if clinically 
warranted, the fragment may be removed via an outpatient procedure 
which involves lancing the abscess and removing the fragment and 
application of a topical antibiotic. 
The risks associated with the Lead fragment removal procedure include 
discomfort during the procedure and skin irritation or infection in the area 
of the retained fragment. These risks are rare. The risk of infection is
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 
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mitigated by instructing the subject and/or his caregiver to carefully
monitor the site and immediately report any signs of infection. 
6) Risk of Lead Replacement due to Lead Migration or Lead Becoming
Dislodged
It is possible that the Lead may migrate from its original intended location
or that the Lead may become dislodged (i.e. come out completely) during
the treatment phase. This risk is rare. If lead migration occurs, it is
possible that the subject may experience discomfort during stimulation
(described further below under “risk of discomfort with electrical
stimulation”). If the Lead has migrated substantially or has come out, it
may be necessary to place another Lead. Each time an additional lead is
placed, the subject has an additional exposure to the same risks of lead
placement described above in “risk of needle insertion for Sprint MicroLead
placement”. 
This risk of lead migration or the becoming dislodged is mitigated by
instructions to the subject and their caregiver, as appropriate, to ensure
careful handling of the Lead and Lead Connector during bandage changes.
In addition, the risk of placing a new lead is further mitigated by ensuring
that Investigators are trained in the lead placement procedure, ensuring
that the shoulder tissue appears healthy prior to placing a new lead, and
collecting an additional INR blood sample for subjects who are taking
warfarin. 
7) Risk of skin irritation under the Sprint Pad or bandages
It is possible that the skin could become irritated under the Sprint Pad.
Additionally, there may be skin irritation in the area surrounding the Lead
insertion site, where an adhesive bandage is taped to the skin. This risk is
common; however, the bandages can be changed to prevent the irritation
from returning. 
The risks of skin irritation under the Sprint Pad (a modified surface
electrode) and under the bandages surrounding the Sprint MicroLead exit
site will be reduced by excluding patients with known sensitivity to skin
surface electrodes and/or medical-grade adhesive tapes. Subjects and
their caregivers will be advised to examine the electrode exit site at
regular intervals to look for any signs of irritation. To avoid irritation under
the Sprint Pad, subjects will be advised that the Sprint Stimulator and
Sprint Pad may be moved to slightly different locations near the Lead
insertion site throughout the treatment phase. In addition, subjects will be
instructed to avoid placing the Sprint Pad or bandages on unhealthy skin. 
8) Risk of mechanical or electrical failure of the Sprint Stimulator
There is a rare chance that the Sprint Stimulator may malfunction. It is
very unlikely that a stimulator malfunction will be harmful. If there is a
problem with the Sprint Stimulator or the Sprint MicroLead, the Stimulator
will reset itself such that no stimulation is delivered. 
The Sprint Stimulator will not deliver stimulation if it detects a high
impedance level indicating a broken lead wire or a faulty lead connection.
Subjects will be instructed to contact study staff in the event that an error
message is displayed. 
9) Risks for pregnant women
The risk of harm to a pregnant woman or fetus is unknown. The device will
not be used in any subjects known to be pregnant. If a subject is known to
become pregnant during the treatment phase, stimulation will be stopped
and the Sprint MicroLead will be removed. 
Potential risks of pregnancy will be reduced by administering a pregnancy
test in females of reproductive potential at study enrollment. Additionally,
the Informed Consent form will advise subjects that the risks of electrical
stimulation during pregnancy are unknown and that they should
immediately notify the Investigator if they suspect they have become
pregnant during the study. 
10) Risk of discomfort due to electrical stimulation
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Intramuscular electrical stimulation may be perceived by the subject as a
tingling or vibrating sensation, which may feel uncomfortable or painful.
The risk of discomfort due to stimulation is uncommon. At high stimulation
intensities, shoulder pain may worsen. 
To minimize the risk of increased shoulder pain as the result of high
intensity stimulation, the Investigator will set an appropriate intensity for
the stimulation. Should a subject feel pain as the result of stimulation, he
or she will be able to turn off the stimulation using the Sprint Stimulator
controls. Although muscle fatigue is unlikely with six hours of daily
stimulation therapy, subjects may also feel some discomfort if muscle
fatigue occurs. If muscle fatigue is observed, the Investigator is able to
prescribe several shorter stimulation sessions totaling six hours per day. 
Discomfort or pain due to stimulation may occur if the Sprint MicroLead
migrates from its original location. Stimulation near the skin surface may
be perceived as a “pins and needles” or stinging sensation and may be
uncomfortable. 
The risk of pain due to a migrating electrode will be minimized by leaving
stimulation off until the Sprint MicroLead has had time to stabilize. The
Sprint MicroLead has a fine wire barb. In addition, the proximal portion of
the Lead exits the skin which makes this Lead more susceptible to
becoming dislodged during bandage changes. As a conservative measure,
we allow one week for encapsulation of the Sprint MicroLead to ensure
stability. Data on the Lead has shown that electrodes are fully
encapsulated by the surrounding tissue. 
A tingling sensation may be felt under the Sprint Pad but this sensation is
not expected to be uncomfortable. If discomfort or pain is felt at the Sprint
Pad site, the subject will be instructed to turn off stimulation and move the
Sprint Pad and Stimulator to a different location. 
11) Risks associated with Diathermy
There is a risk of tissue damage if a subject undergoes diathermy.
Shortwave or microwave diathermy is a therapy that may be used to apply
deep therapeutic heat for the treatment of selected medical conditions
such as relief of pain, muscle spasms, and joint contractures. Diathermy
can cause excessive heating of any implanted metal part (including Leads),
resulting in serious injury. The risk of tissue damage associated with
diathermy is rare. 
The risk of diathermy will be reduced by informing subjects that diathermy
must not be used. In addition, subjects will be informed to never undergo
diathermy if a Sprint MicroLead fragment remains in the body. 
12) Risks associated with MRI
Tissue damage may occur if a subject undergoes an MRI procedure while
the Sprint MicroLead, or a fragment of the Sprint MicroLead, is in the body.
The risk of tissue damage associated with MRI use is rare.  
Should a subject require a scheduled MRI during the treatment phase, the
Sprint MicroLead will be removed. The decision to remove any remaining
fragments will depend on a careful assessment of the benefits of the MRI,
risks of MRI with retained fragments and risks associated with removing of
electrode fragments. 
13) Risk of allergic reaction to local anesthetics and/or risk of accidental
injection of local anesthetic into a vein
There is a risk that the subject may have an allergic reaction to the local
anesthetic used during the treatment phase prior to insertion of the Sprint
MicroLead. If the subject were to have an allergic reaction, it would usually
happen while the subject was still in the clinic. If a subject complains of
itching, difficulty breathing, lightheadedness and dizziness, or a swollen
tongue (common signs of an allergic reaction), appropriate medical
treatment will be administered. The risk of allergic reaction to local
anesthetics is rare. In addition, there is a risk of adverse central nervous
system and/or cardiovascular effects (including a rare risk that the
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subject’s heart can stop beating or that they could stop breathing) if the
local anesthetic is administered improperly. 
The risks of allergy to local anesthetic agents will be reduced by excluding
subjects with a prior known history of allergy or sensitivity to local
anesthetic agents. In addition, prior to the procedure, subjects will be
advised of the signs and symptoms of an allergic reaction. Because
subjects will be awake during this procedure, they will be able to verbalize
any itching or other signs of allergy to the local anesthetic. The risks of
accidental intravascular injection of local anesthetic will be reduced by
careful administration of the local anesthetic. Careful administration
includes ensuring that a vein has not been punctured by the syringe prior
to injecting the anesthetic and observing the subject after the injection. In
addition, the physical location of the anesthetic injection (in the deltoid)
combined with the injection technique would rarely result in an accidental
intravascular injection. 
14) Risk associated with venipuncture (if applicable)
The risks of drawing blood from a vein include discomfort at the site of
puncture, possible bruising and swelling around the puncture site, an
infection, and faintness from the procedure. The risks of discomfort,
bruising, and swelling around the puncture site are common while the risks
of infection and fainting are rare. Blood sample collections are only
required in subjects taking warfarin.  
Subjects taking warfarin are at greater risk for developing bruises
following venipuncture. However, the risk of discomfort and bruising at
that puncture site will be reduced by applying gentle pressure following
venipuncture as is the standard practice for collection of blood samples.
The rare risk of infection due to venipuncture will be reduced by using
proper blood collection technique including wiping the puncture site with
an appropriate cleansing solution. 
Some subjects may experience a vasovagal (“fainting”) response due to
the discomfort of needle insertion or anxiety associated with the
procedure. The risk of fainting will be reduced by observing subjects
during and following venipuncture to ensure that they feel comfortable
rising from their seated position. Subjects with a history of vasovagal
responses will be supine during venipuncture. 
15) Risk of worsening of pain symptoms
It is possible that the subject may have a worsening of pain symptoms or
that they may not obtain any therapeutic benefit from the treatment. The
risk of worsening pain symptoms is uncommon. In addition, subjects will
have the opportunity to discontinue treatment if their stimulation is too
uncomfortable. 
These risks are mitigated by clinical training on the safe limits. Subjects do
not have access to make changes to the programming controls and thus
could not advertently change the value. 
16) Risks of Outcomes Assessments
The questionnaires and Fugl-Meyer Assessment present no risks. The
assessments of shoulder torque and kinematics may be slightly
uncomfortable. The measures of central sensitization (mechanical pain
thresholds for hyperalgesia, pinprick pain thresholds for hyperalgesia,
temporal summation of repetitive pin-prick stimuli) may be slightly
uncomfortable and may cause brief skin irritation. The optional measures
(tactile/touch, vibration and thermal/thermal pain detection thresholds,
temporal summation of repetitive thermal stimuli, and Conditioned Pain
Modulation (CPM)) also may be uncomfortable and may cause brief skin
irritation. 
17) Other
Some of the survey questions present a rare risk of psychological harm. 
When PHI is involved there is the rare risk of a privacy breach. 
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There may be other risks as yet unknown. 
10.6 
Are there defined stopping rules? 
Yes 
No
What are the stopping rules for the study? What are the conditions under
which a subject will be withdrawn from the study for safety reasons, i.e.
disease progression? 
The study could be terminated at any time for valid scientific reasons or reasons
related to the protection of subjects participating in this study. A reason for study
termination includes but is not limited to the discovery of an unexpected,
significant, or unacceptable risk to the participants enrolled in the study. 
What findings, events, or conditions would require a research subject to be
removed from the study? (i.e. disease progression) 
The research subject may be removed if they develop any condition during the
course of the study which would preclude the safe use of stimulation or otherwise
impair their safe participation in any study activity. 
Describe in enough detail for
the IRB to assess safety. 
10.7   
What Category of risk will study participants be exposed too? 
Name
Psychological
Physical
Privacy
Should be consistent with risks
listed in the Consent Form.
10.8
10.9
If Other listed above please specify: 
Describe the availability of medical or psychological services that
participants might require as a consequence of participation in this the
research: 
It is not expected that participants would require medical or psychological services
as a consequence of participation in this research. If that were to occur, appropriate
referrals would be made for the subject. 
A text box is provided for
further explanation.
A text box is provided for
further explanation. 
10.10
Describe in detail any measures in place to minimize or protect against the
exposure of study subjects to these risks: 
1) Risks associated with needle insertion for Sprint MicroLead placement
To minimize the risks associated with percutaneously placing fine wire leads, only
appropriately trained physician investigators will perform the procedure. In addition,
the risk of excessive bleeding will be reduced by excluding candidates who are
taking warfarin with an INR > 3.0 and by placing manual pressure on the
implantation site until hemostasis is achieved. Finally, the risk of discomfort during
the procedure will be reduced by the use of an appropriate amount of local
anesthetic. 
Some participants may experience a vasovagal (“fainting”) response due to the
discomfort or anxiety associated with of the procedure, especially among those with
prior history of “fainting.” This risk is rare and may be associated with symptoms of
lightheadedness, dizziness and or diaphoresis with concomitant reduction in blood
pressure and heart rate. For those with prior history of “fainting” the procedure will
be performed with the subject in the lateral decubitus position. 
2) Risk of skin irritation, infection, or inflammation at the Sprint MicroLead exit site
These risks will be minimized by using sterile Leads and thoroughly cleansing the
insertion site with antibacterial solution at the time of insertion. The insertion site
will be covered with a dressing to keep it clean and dry, and the subjects and their
caregivers will be instructed to inspect the site for signs of infection or irritation
regularly and to inform the Investigator if they occur. If infection or skin irritation
occurs, the Investigator will administer an antibiotic and/or remove the Lead.
Infections are rare and typically resolve after Lead removal and antibiotic
treatment. 
Discuss any provisions for
intervention in the event of an
Adverse Event i.e. stopping
rules.
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
NCT02928055

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It should be noted that in a completed clinical trial of percutaneous intramuscular
electrical stimulation, one patient death occurred. The subject did not follow the
instructions for the care of the Lead exit site and also did not return for his
scheduled follow-up visit following electrode placement. He developed an electrode
related infection and was hospitalized. The cause of death is thought to be a
myocardial infarction or a pulmonary embolus, but the exact cause of the death and
its relationship to the infection are not known. To mitigate the potential risk of
serious infection, a 48-72 hour safety check will be performed after the procedure.
Participants will return to the clinic and the exit site will be evaluated for signs of
infection. 
3) Risk of the Sprint MicroLead breaking beneath the skin
The risk of leaving a Lead fragment is minimized by reducing the amount of time
the Lead remains implanted and the number of Leads implanted. In this protocol, a
single Sprint MicroLead will be implanted for just 4 weeks. 
4) Risk of infection associated with retained Sprint MicroLead fragments
Investigators at the Cleveland FES Center and Case Western Reserve University
have over 30 years of experience with dozens of research participants and hundreds
of implanted leads like those used in this study. Infections and granulomas of leads
or lead fragments have been uncommon, which is attributed to the materials and
procedures that have been developed as well as the extensive experience of the
Investigators. 
5) Risks associated with lead fragment removal
Subjects will be instructed to contact the Investigator if there are any signs of pain,
redness, swelling, discharge, or the appearance of a pimple-like mass (skin
abscess). Such signs indicate that the fragment has migrated to the skin surface. At
that time, if clinically warranted, the fragment may be removed via an outpatient
procedure which involves lancing the abscess and removing the fragment and
application of a topical antibiotic. 
6) Risk of Lead Replacement due to Lead Migration or Lead Becoming Dislodged
It is possible that the Lead may migrate from its original intended location or that
the Lead may become dislodged (i.e. come out completely) during the treatment
phase. Each time an additional lead is placed, the subject has an additional
exposure to the same risks of lead placement described above in “risk of needle
insertion for Sprint Micro Lead placement”. 
This risk of lead migration or the becoming dislodged is mitigated by instructions to
the subject and their caregiver, as appropriate, to ensure careful handling of the
Lead and Lead Connector during bandage changes. In addition, the risk of placing a
new lead is further mitigated by ensuring that Investigators are trained in the lead
placement procedure, ensuring that the shoulder tissue appears healthy prior to
placing a new lead, and collecting an additional INR blood sample for subjects who
are taking warfarin. 
7) Risk of skin irritation under the Sprint Pad or bandages
The risks of skin irritation under the Sprint Pad (a modified surface electrode) and
under the bandages surrounding the Sprint MicroLead exit site will be reduced by
excluding patients with known sensitivity to skin surface electrodes and/or medical-
grade adhesive tapes. Subjects and their caregivers will be advised to examine the
electrode exit site at regular intervals to look for any signs of irritation. To avoid
irritation under the Sprint Pad, subjects will be advised that the Sprint Stimulator
and Sprint Pad may be moved to slightly different locations near the Lead insertion
site throughout the treatment phase. In addition, subjects will be instructed to
avoid placing the Sprint Pad or bandages on unhealthy skin. 
8) Risk of mechanical or electrical failure of the Sprint Stimulator
There is a rare chance that the Sprint Stimulator may malfunction. It is very
unlikely that a stimulator malfunction will be harmful. If there is a problem with the
Sprint Stimulator or the Sprint MicroLead, the Stimulator will reset itself such that
no stimulation is delivered. 
The Sprint Stimulator will not deliver stimulation if it detects a high impedance level
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
NCT02928055

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indicating a broken lead wire or a faulty lead connection. Subjects will be instructed
to contact study staff in the event that an error message is displayed. 
9) Risks for pregnant women
The risk of harm to a pregnant woman or fetus is unknown. The device will not be
used in any subjects known to be pregnant. If a subject is known to become
pregnant during the treatment phase, stimulation will be stopped and the Sprint
MicroLead will be removed. 
Potential risks of pregnancy will be reduced by administering a pregnancy test in
females of reproductive potential at study enrollment. Additionally, the Informed
Consent form will advise subjects that the risks of electrical stimulation during
pregnancy are unknown and that they should immediately notify the Investigator if
they suspect they have become pregnant during the study. 
10) Risk of discomfort due to electrical stimulation
To minimize the risk of increased shoulder pain as the result of high intensity
stimulation, the Investigator will set an appropriate intensity for the stimulation.
Should a subject feel pain as the result of stimulation, he or she will be able to turn
off the stimulation using the Sprint Stimulator controls. Although muscle fatigue is
unlikely with six hours of daily stimulation therapy, subjects may also feel some
discomfort if muscle fatigue occurs. If muscle fatigue is observed, the Investigator
is able to prescribe several shorter stimulation sessions totaling six hours per day. 
Discomfort or pain due to stimulation may occur if the Sprint MicroLead migrates
from its original location. Stimulation near the skin surface may be perceived as a
“pins and needles” or stinging sensation and may be uncomfortable. 
The risk of pain due to a migrating electrode will be minimized by leaving
stimulation off until the Sprint MicroLead has had time to stabilize. The Sprint
MicroLead has a fine wire barb. In addition, the proximal portion of the Lead exits
the skin which makes this Lead more susceptible to becoming dislodged during
bandage changes. As a conservative measure, we allow one week for encapsulation
of the Sprint MicroLead to ensure stability. Data on the Lead has shown that
electrodes are fully encapsulated by the surrounding tissue. 
A tingling sensation may be felt under the Sprint Pad but this sensation is not
expected to be uncomfortable. If discomfort or pain is felt at the Sprint Pad site, the
subject will be instructed to turn off stimulation and move the Sprint Pad and
Stimulator to a different location. 
11) Risks associated with Diathermy
The risk of diathermy will be reduced by informing subjects that diathermy must
not be used. In addition, subjects will be informed to never undergo diathermy if a
Sprint MicroLead fragment remains in the body. 
12) Risks associated with MRI
Should a subject require a scheduled MRI during the treatment phase, the Sprint
MicroLead will be removed. The decision to remove any remaining fragments will
depend on a careful assessment of the benefits of the MRI, risks of MRI with
retained fragments and risks associated with removing of electrode fragments.
13) Risk of allergic reaction to local anesthetics and/or risk of accidental injection of
local anesthetic into a vein
The risks of allergy to local anesthetic agents will be reduced by excluding subjects
with a prior known history of allergy or sensitivity to local anesthetic agents. In
addition, prior to the procedure, subjects will be advised of the signs and symptoms
of an allergic reaction. Because subjects will be awake during this procedure, they
will be able to verbalize any itching or other signs of allergy to the local anesthetic.
The risks of accidental intravascular injection of local anesthetic will be reduced by
careful administration of the local anesthetic. Careful administration includes
ensuring that a vein has not been punctured by the syringe prior to injecting the
anesthetic and observing the subject after the injection. In addition, the physical
location of the anesthetic injection (in the deltoid) combined with the injection
technique would rarely result in an accidental intravascular injection. 
14) Risk associated with venipuncture (if applicable)
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
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Subjects taking warfarin are at greater risk for developing bruises following
venipuncture. However, the risk of discomfort and bruising at that puncture site will
be reduced by applying gentle pressure following venipuncture as is the standard
practice for collection of blood samples. The rare risk of infection due to
venipuncture will be reduced by using proper blood collection technique including
wiping the puncture site with an appropriate cleansing solution. 
Some subjects may experience a vasovagal (“fainting”) response due to the
discomfort of needle insertion or anxiety associated with the procedure. The risk of
fainting will be reduced by observing subjects during and following venipuncture to
ensure that they feel comfortable rising from their seated position. Subjects with a
history of vasovagal responses will be supine during venipuncture. 
15) Risk of worsening of pain symptoms
It is possible that the subject may have a worsening of pain symptoms or that they
may not obtain any therapeutic benefit from the treatment. The risk of worsening
pain symptoms is uncommon. In addition, subjects will have the opportunity to
discontinue treatment if their stimulation is too uncomfortable. 
These risks are mitigated by clinical training on the safe limits. Subjects do not
have access to make changes to the programming controls and thus could not
advertently change the value. 
16) Risks of Outcomes Assessments
If the subject feels discomfort, they may request that the outcomes assessments be
paused. Measures will be taken to improve their comfort if possible. Skin irritation,
should it occur, should resolved shortly after the cause is removed.  
17) Other
Subjects may choose not to answer survey questions that make them
uncomfortable. 
Privacy breach precautions are included in Sections 15-17. 
There may be other risks as yet unknown. 
10.11
Please add any documents related to the above questions: 
Name
Description
There are no items to display
If your answers to the above
questions are too long for the
space provided please attach
them here. 
View: 10-02 Risk/Benefits
10.2   Benefits:
10.12 
Describe the potential benefits to the subject as a result of participating in
this research. If there is no direct benefit to subjects please state that as
well: Note: payment or compensation to subjects for participation is not to
be considered a potential benefit. 
Participants may experience substantial pain reduction, and all subjects are
receiving active treatment.
Describe potential benefits to
the study subjects.
10.13
Describe the potential benefits to society as result of this research: 
The primary benefit will be the clinical and scientific knowledge gained.
Describe potential benefits to
society.
10.14 
What is the risk/benefit ratio of the research? 
The primary benefit will be the clinical and scientific knowledge gained as described
above. Participants may experience substantial pain reduction, and all subjects are
receiving active treatment. Due to the need for invasive procedures, participants will
be exposed to greater than “minimal risk.” However, the potential benefits to
participants, other patients with chronic HSP, and the scientific/rehabilitation
community are substantial. Therefore, the risk benefit ratio is acceptable. 
Discuss why the risks are
reasonable in relation to the
anticipated benefits. 
10.15
Attach Documents: 
Name
Description
There are no items to display
Attach documents here. 
View: 11-00 Study Participant Information I
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
NCT02928055

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11.0 Study Participant Information I:
11.1 
11.2 
How will the Principal Investigator assure he/she has access to a
population that would allow recruitment of the required number of study
participants (i.e. prep for research): 
The participants needed for this study at MetroHealth are expected to be recruited
from the clinics of the Investigators and via referral from other PM&R stroke
physicians. Additionally, potential participants may be recruited from the Greater
Cleveland area (as allowed for in the Recruitment section). 
Anticipated number of subjects (all sites): [enter a number] 
30
Anticipated number of subjects to be enrolled at MHS: [enter a number] 
30
Anticipated number of potential subjects to be approached: [enter a
number] 
100
How does the PI know he/she
has the required number of
subjects?
Please give the total #of
subjects to be enrolled at all
sites and anticipated subjects to
be enrolled at MHS.   
11.3
If this is a multi-site study, how many sites will there be? [enter a number] 
How many total sites?
11.4 
Subject Characteristics: 
Subject Population Categories
Outpatients
Patients with the "disease in question"
Check all that apply
11.5
Subject Source: 
Subject Source Characteristics
Subjects from the Practice of the Principal Investigator
Subjects referred or recruited from other physicians practices
Public subject recruitment by advertisement, flyers, websites etc. (Note: required
IRB review and approval)
Check all that apply
11.6
If "other" list above in either 11.4 or 11.5 please describe: 
If applicable please describe. 
View: 12-00 Study Participant Information II
12.0  Study Participant Information II:
12.1 
Select age range of study participants: 
Subject Age Range
18 - 64
65 - 89
Check all that apply. 
12.2
* Will the study enroll vulnerable subject groups?
Yes
* Will you be enrolling Children?
Yes 
No
* Will you be enrolling Pregnant Women and/or Fetuses?
Yes 
No
* Will you be enrolling decisionally impaired subjects?
Yes 
No
Check yes or no.
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
NCT02928055

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* Will you be enrolling Prisoners?
Yes 
No
12.3 
Please identify any vulnerable populations participating in the study: 
Vulnerable Populations
Poor / Uninsured
Elderly
Minorities
Cognitively Impaired
Check all that apply.
12.4
12.5
If you selected "other" above please describe: 
If you are going to enroll any vulnerable populations please describe the
safeguards you will put in place to protect these vulnerable Populations.  
All potential subjects will be assured that they may decline participation without
jeopardizing their medical and rehabilitation care or compromising their relationship
with their physician or MetroHealth Medical Center. All subjects have an opportunity
to review the consent forms at home and discuss participation with family, friends,
etc. PHI will remain at Metro, except enrolled research participants will be told that
their names and contact information will be shared with the device manufacturer for
tracking purposes (addressed in HIPAA Authorization). Metro paper records with PHI
are kept in locked cabinets in locked rooms. For PHI stored electronically, password
protected secure MHS network drives will be used for electronic data in folders with
access limited to those who are authorized by this protocol. Any data stored on
portable media and/or removed from Metro would be deidentified. 
Please describe other.
Please enter a detailed plan.
View: 13-00 Recruitment I
13.0  Recruitment I:
All external advertisements (for radio, print media or TV) must be approved by MHS Communications
Department prior to submission to the IRB so the IRB can see the final advertisement or script. All
Advertisements on the MIV or On Hold messaging must be approved by the IRB before they are placed. You
may not advertise a study which is not approved by the IRB. Please note that all studies which have a
contract which an external sponsor must have that contract signed before any advertising can be done.
13.1 
Recruitment Methods/Sources: 
Name
Internet/Web/MetroHealth Intranet
Advertisements-Newspapers/Magazines, Television, Radio
Notices/Posters/Flyers
Letters
Check all that apply. 
13.2
If "Other" checked in 13.1 please explain: 
Please explain what other
means.
13.3 
Describe in detail all recruitment strategies for each subject group (as listed
in Section 11.0) selected for this research:  
Subjects will be recruited from the outpatient stroke and brain injury rehabilitation
programs at MetroHealth Medical Center (MHMC), as well as from the Greater
Cleveland area. At MHMC, subjects will be recruited via direct referral from clinicians
within the Department of PM&R, and many will already be Dr. Wilson's or Dr. Chae's
patients. 
Study subjects may be recruited from the following additional sources: 
• All applicable MetroHealth Medical Center outpatient clinics and clinical departments
(e.g., Family Practice, Internal Medicine, Neurology, Orthopaedics, etc.)
• University Hospitals and affiliate hospitals
• Cleveland Clinic and affiliate hospitals
• Other appropriate area physicians/hospitals/clinics/facilities
• Skilled nursing facilities/units
• Visiting nurse associations
• Nursing homes
• Assisted living facilities
Please describe recruitment
strategies in detail.
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
NCT02928055

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• Stroke support groups or forums
• Senior/community/recreation centers
Study subjects may be recruited using the following additional methods: 
• Print advertisements (e.g., newspapers, periodicals, newsletters). May also be used
for radio spots. Metro Communications will have approved.
• Craigslist advertisements. Metro Communications will have approved.
• Flyers and/or brochures.
• MetroHealth Website Stroke Research Information Page. Basic study and contact
information will be displayed on a webpage associated with the MHS website.
Developed in cooperation with Metro Communications.
• MetroHealth Voicemail and On-Hold Messaging. Metro Communications will have
approved.
• Approved recruitment materials placed with permission on Bulletin Boards at
appropriate locations in the MetroHealth System or at other locations (e.g., at other
institutions, at conferences).
• In-service presentations at any of the locales listed above. Approved recruitment
materials may be distributed or displayed.
• Stroke Research Introductory Contact Cards (the size of a business card) will be
made available for inclusion with mailings, distribution by clinicians, distribution at
inservices or other meetings, etc.
• Appropriate Informational Internet Sites (e.g., clinicaltrials.gov, MHS Clinical Trials
Website).
• A recruitment campaign will be commissioned from Splash Clinical.
Initially, candidates who respond will be informally screened (possibly over the
phone). Those who pass the informal screening will be scheduled for a formal, more
detailed assessment of eligibility by the study team, usually including the PI or a
physician co-investigator. An informed consent form will be provided for review,
usually in advance. During the Eligibility visit, the clinical nurse coordinator will
describe the research, review the consent form with the candidate, address all initial
questions (with referral to the PI or a physician co-investigator as per the candidate’s
request and the clinical nurse coordinator’s discretion), and request participation in
the study. Discussion is encouraged during the exchange to gauge subject
comprehension. Candidates are free to take more time to think about it, consult with
family or friends, and have additional questions answered if they wish. If and when a
candidate agrees to participate, they sign the consent form, after which the formal
assessment of eligibility takes place. Subjects may ask questions at any time. All
questions will be answered. 
13.4
What measures will be taken during the recruitment process to safeguard
against the potential coercion or appearance of coercion of human subjects,
particularly vulnerable subject groups?  
All potential subjects will be assured that they may decline participation without
jeopardizing their medical and rehabilitation care or compromising their relationship
with their physician or MetroHealth Medical Center. All subjects have an opportunity
to review the consent forms at home and discuss participation with family, friends,
etc. 
Please give an explanation of
safeguards to be used.
13.5
Incentives to Subjects: Will subjects receive any incentives (payments, free
service, gifts, etc.) for participation in the research? 
No
This information must mirror
the consent form language.
 13.6
If yes, please describe these incentives and how they will be disbursed:
Note: payment or compensation to subjects for participation is not to be
considered a potential benefit. 
Transportation may be arranged for the study participant and covered by the study
budget. Parking also can be paid or reimbursed.
Describe incentives, if they are
to be pro-rated based on visits
completed please give that
information. This information
must mirror consent form
language.
13.7
Please attach copies of all recruitment/advertising materials and verbal
scripts:  
Name
Version
PNS Dose for HSP Appointment Reminder | History
0.01
PNS Dose for HSP Brochure (30-Nov-2017) | History
0.06
PNS Dose for HSP Consent Cover Form Letter | History
0.03
Attach copies of all recruitment
and advertising materials.
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
NCT02928055

Print: IRB16-00510 - PNS Dose for HSP
https://mhirb.metrohealth.org/IRB/ResourceAdministration/Project/PrintSmartForms?Project=com.webridge.entity.Entity%5BOID%5B111D262BB79…
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Name
Version
PNS Dose for HSP Evaluation Cover Form Letter | History
0.03
PNS Dose for HSP Flier | History
0.02
Poster - PMR Research (5 versions with varying logos, Sep 2017) | History
0.02
Poster - Shoulder Pain (5 versions with varying logos, Sep 2017) | History
0.02
Shoulder Pain Studies Recruitment Video (21-Jun-2017) | History
0.02
Splash Clinical -- MetroHealth Campus_Stroke Study_Marketing
Materials_10.3.17 | History
0.01
Stroke Research Ad 5.0 for Craigslist (24-Jul-2013) | History
0.01
Stroke Research Ad 6.0 (02-Dec-2016) | History
0.01
Stroke Research Introductory Contact Cards 4.0 (16-May-2012) | History
0.01
Stroke Research Metro In-House Messaging 5.0 (24-Jul-2013) | History
0.01
View: 13-01 Recruitment II
13.1  Recruitment II:
13.8 
Expense to Subjects: Will subjects incur any expenses as a result of
participation in the study or will they be billed for any study-related
procedures? 
No  
Check yes or no, make sure this
information is in the consent.
13.9
If yes, please describe the expenses or charges that subjects will be
assessed: 
Please provide information
regarding expenses to subjects
and add information to
consent.   
13.10 
Compensation For Injury: If applicable, will funding be available to
compensate subjects for injuries sustained as a result of participation in
this research? 
No  
Check yes or no, make sure this
information is in the consent.  
13.11
Who will cover the costs related to any injuries sustained due to
participation in the study? 
The subject and his/her insurance carrier will be responsible for these costs. 
Please describe in detail.
Examples subjects or their
insurance company, study 
sponsor.
View: 14-00 Data Collection
14.0 Data Collection:
14.1 
A. What type of data will you be collecting as part of this research?
Will you collect existing data? 
or
Will you collect prospective data? 
Yes 
No
or
Will you collect both existing and prospective data? 
Yes 
No
Definitions: Data are considered to be existing data only if they were in
place or "on the shelf" prior to the submission of the research protocol to
the IRB.  Data are considered prospective if they are created and collected
as part of the research i.e. from surveys, questionnaires. 
B. Why are you collecting this data?
What will be the purpose of collecting and/or reviewing the data (new data
or existing data). 
The data collected in this study will be used to determine and document eligibility
and suitability for the study, to establish baseline data for the study, to document
status throughout the study, and to determine the effects of the intervention
provided during the study. 
Existing data must be in place
or on the shelf prior to the
submission of the research
protocol to the IRB.
Prospective data is collected in
real time.
Tell the IRB why you are
collecting this data i.e. to verify
inclusion criteria.
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
NCT02928055

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14.2
If you are collecting existing data:
Specify the type(s) of existing data sources you will use (medical records,
school records, publicly available records, existing database). If you are
collecting data from an exisitng database and that database contains PHI,
you must provide the IRB Approval letter (attach to Section 27.00
Additional Documents). 
During the baseline visit, subjects will be queried for existing medical history,
including medication usage. In addition, data to collect descriptive characteristics
(e.g, age, duration shoulder pain, ethnicity) will be collected from the medical
record. 
What is the timeframe of the existing data you wish to review? (i.e. 2000-
2006) 
The timeframe will be patient-dependent, covering the time since their first stroke
and/or first evaluation for shoulder pain. 
Specify the types of existing
data you will use in this study. 
Time frame i.e. last 10 years or
from 1990-2000.
14.3 
If you are collecting prospective data:
Where or how will the data be obtained? (i.e. surveys, questionnaires,
psychological tests) 
Data will be collected during each visit to MHMC and during phone calls when visits
are not necessary. Data that is collected is described in detail at 8.4, 8.6 and 10.4. 
Where will data
be obtained? i.e. survey.
14.4
How will the data you collect be identified?
Types of Data Identification: 
Name
Deidentified/Confidential- Data will be linked to subject(s) via a code or indirect
identifier (i.e. study IDs or numbers)
Identifiable- Data will be linked to subject(s) via direct identifier (names, medical
records numbers, etc.)
Please select how your subject
data will be identified.
14.5
14.6 
Will the information collected from these records be linked to any research
subjects by identifiers? (i.e. name, MRN#, DOB) 
Yes 
No
Please answer questions about the security of the data in section 15.00
If subject data will be deindentified using a code will there be a link or
a key? Please describe. Who will have the key and where will the key be
kept?  
Data will be maintained by the study coordinator in study protocol binders. Data will
be deindentified and labeled with each subject’s ID. The Subject ID Log which
provides a link between the subject ID and patient name will be kept on Redcap,
accessible to study staff. 
Under the HIPAA Regulations, deidentified key codes must be stores
separately from data & must not be kept on paper, but electronically. The
MetroHealth Research Informatics Support should be contacted at
REDcap@metrohealth.org for assistance. They will assist personnel in
developing a key in MetroHealth REDcap database. They can also assist
with training & development for your study. REDcap is a free database
provided in part by the Case CTSA.
Will your data be linked to
subjects?
Explain how Data will be linked. 
14.7
Data Collection Form(s): 
Name
Version
PNS Dose for HSP Adverse Event | History
0.01
PNS Dose for HSP Assessment CRFs (23-Feb-2017) | History
0.04
PNS Dose for HSP Medication Diary | History
0.01
PNS Dose for HSP Study Termination (27-Oct-2016) | History
0.02
PNS Dose for HSP Survey Outcomes Visits (27-Oct-2016) | History
0.02
Add data collection forms and
CRFs.
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
NCT02928055

Print: IRB16-00510 - PNS Dose for HSP
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Name
Version
PNS Dose for HSP Treatment CRFs (07-Jun-2017) | History
0.04
PNS Dose for HSP Unscheduled Study Visit (27-Oct-2016) | History
0.02
REDCAP Data Collection Forms(all forms) | History
0.01
View: 15-00 Data Security I
15.0 Data Security I:
It is imperative that the IRB is proactive and consistent in protecting all research data containing Protected Health
Information(PHI).
15.1 * Are the records for this study (some or all) electronic? 
Yes 
No
What is Protected Health Information? The Privacy Rule protects certain information that covered entities use and
disclose. This information is called protected health information (PHI), which is generally individually identifiable
health information that is transmitted by, or maintained in, electronic media or any other form or medium. This
information must relate to 1) the past, present, or future physical or mental health, or condition of an individual; 2)
provision of health care to an individual; or 3) payment for the provision of health care to an individual. If the
information identifies or provides a reasonable basis to believe it can be used to identify an individual, it is
considered individually identifiable health information.
The following questions must be answered when submitting a new protocol. 
15.2       * Are you collecting PHI?   
Yes 
No 
15.3       Is any PHI going to be stored as paper files?   
Yes 
No
15.4       Is any PHI going to be stored in an electronic file format? (i.e. access, excel) 
Yes 
No
15.5       Is your data being stored on a laptop computer?   
Yes 
No
15.6       Will you be using RedCap to store your data?   
Yes 
No
Which RedCap Database will you be using? 
Name
MetroHealth
Case
15.7       Are you planning to store your data using a portable storage device?(i.e. jump drive, external hard drive,
cd)
Yes
No
*Per current MetroHealth Policy PHI may not be stored on portable electronic devices.
15.8       Are there any circumstances under which you would want to remove data from MHS? (i.e. take data home
to work on it) Give details below. Please note identified data can't be removed from MHS unless there is permission
granted in the HIPAA Authorization. If you are unsure about what is identified data please consult the IRB staff. If
you feel you will need access to your data when you are off campus you should ask the MHS IT Department located
in Rammelkamp room R 134 about VPN access.   
Yes 
No
If you answered yes to question 15.8, please explain? 
PHI will remain at Metro. Any data stored on portable media and/or removed from Metro would be deidentified. Such data may be
transported to work on elsewhere. 
15.9
Where will the records pertaining to this research be stored? (give the
actual physical location of the paper records i.e building name and room
number); and/or the secure network drive where the data is being
stored. 
Electronic records (inc. electronic photos & videos): For PHI stored electronically,
password protected secure MHS network drives will be used for electronic data in
folders with access limited to those who are authorized by this protocol. The
Subject ID log will be stored on Metro Redcap. Most study data (deidentified) will
be stored in a database on Case Redcap. For portable media or other computers
such as laptops, only deidentified data will be stored. 
Paper records (inc. non-electronic photos & videos): For this study, these records
are stored in the following staff offices which are locked when unoccupied: N5-86,
State the exact physical
location of paper files and the
network drive for electronic
files. 
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
NCT02928055

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N5-43. Also, the PI’s office is N2-19. These records with PHI are kept in locked
cabinets in these rooms. 
15.10
How will these records be secured (we are refering to both paper records
and electronic records)? Examples for electronic records (i.e. secure
drive, password protected documents, encrypted jump drive). Examples
for paper records, must be double locked (i.e. locked office and locked file
cabinet or a locked file box inside a locked cabinet). 
Offices, Labs and storage cabinets are kept locked. EPIC, which is secured, also
will be used. For PHI stored electronically, password protected secure MHS
network drives will be used for electronic data in folders with access limited to
those who are authorized by this protocol. Only deidentified data will be stored on
portable media. Non-electronic records are kept in locked cabinets in rooms that
are locked when unoccupied. 
i.e. locked cabinet, locked
room.
15.11    
Who will have access to the data? 
Non-Metro staff who will have access to at least some PHI as well as deidentified
data include the following study staff: Gregory Naples (Research Program
Manager). If necessary, representatives of the Metro IRB, NIH, and FDA will also
have access. 
Please Note: All study documents must be retained for a minimum of four years
after study completion (even when no subjects have been enrolled), twenty-two
years if study involves children or pregnant women. Records for device studies
must not be assigned a destruction date until the FDA approval status is
determined, at which point records will be retained according to the scheme above
(minimum of four or twenty-two years as appropriate). Under HIPAA regulations
you must keep a record of all medical records where you looked at or recorded
PHI (without a HIPAA Authorization) for 6 years (i.e. prep for research).
MHS Record Retention Policy VII-4
Give name and title exclude
study staff who are MHS
employees.
15.12
15.13
How long will you keep the records pertaining to this research? Where
will these records be stored after the study has been completed?  
The PI will store these records indefinitely since it is unknown exactly how long it
will be necessary to maintain the records for possible later review and potential
additional analysis in response to post-publication inquiries from the funding or
scientific communities, or in support of new grant proposals. After completion of
the study, the records will continue to be stored as already described: 
Electronic records (inc. electronic photos & videos): For PHI stored electronically,
password protected secure MHS network drives will be used for electronic data in
folders with access limited to those who are authorized by this protocol. The
Subject ID log will be stored on Redcap. For portable media or other computers
such as laptops, only deidentified data will be stored. 
Paper records (inc. non-electronic photos & videos): For this study, these records
are stored in the following staff offices which are locked when unoccupied: N5-46,
N5-43. Also, the PI’s office is N2-19. These records with PHI are kept in locked
cabinets in these rooms. 
Offices, Labs and storage cabinets are kept locked. EPIC, which is secured, also
will be used. For PHI stored electronically, password protected secure MHS
network drives will be used for electronic data in folders with access limited to
those who are authorized by this protocol. Only deidentified data will be stored on
portable media. Non-electronic records are kept in locked cabinets in rooms that
are locked when unoccupied. 
Where, when, and how will the information be destroyed? 
If and when it is determined that the information is to be destroyed, paper and
electronic records will be destroyed in compliance with MHS policies and
methodologies. 
*Please Note: There are EPA regulations surrounding the destruction of
CDs, DVDs, Floppy discs and other portable storage media. If you want to
destroy these types of media please contact Ron Wallace in Environmental
Services at 778-4776.
Check the MHS Record
retention policy for guidance.
You must have a plan for data
destruction.
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View: 15-01 Data Security II
15.1 Data Security II:
15.14
Who (non-study staff) will have access to the records? Give name and title
of individuals. Where an individual's name is not known give title i.e.
monitor from CRO. 
If necessary, representatives of the Metro IRB, NIH, and FDA will have access. 
List all those not study staff
who will see and have access to
data.
15.15
Will data be transmitted to the sponsor?
Yes 
No 
Are you sending CRFs to
sponsor?
15.16
If yes, describe what data will be sent to the sponsor and the provisions
that have been made for preservation of confidentiality in the transmission
of data to the sponsor: 
Deidentified information and results will be sent to the funding agency (NIH). 
If necessary, FDA is authorized to review information. 
Please describe i.e. will you be
using encryption software?
15.17
Will the data from this research project be transmitted to anyone other
than the sponsor?   
Yes 
No
Check yes or no.
15.18 
If yes, to whom will this data be transmitted? 
Please describe organization or
individual.
15.19
Describe the data that will be sent to entities other than the sponsor and
what provisions have been made for the preservation of confidentiality: 
Please describe data, and
confidentiality provisions.
View: 16-00 Request for a Partial Waiver of HIPAA Authorization
16.00 Request For a Partial Wavier of HIPAA Authorization
An IRB, under certain circumstances, may allow researchers to forgo obtaining an authorization; this is called a waiver of authorization. A waiver
of authorization may be full or partial:
full waiver: an IRB waives the requirement for authorization for all uses of PHI for a particular research protocol (see Section 16.01
Request for a Waiver of HIPAA Authorization);
partial waiver: an IRB waives the requirement for an authorization only for some uses of PHI for a particular research protocol.
Researchers are required to obtain subjects' Research Authorizations after recruiting and enrolling subjects via a partial waiver and prior to
creating or using PHI during research procedures.
Partial Waiver for Preparatory for Research Activities:
According to HHS guidance on the Privacy Rule the preparatory to research provision permits covered entities to use or disclose protected
health information for purposes preparatory to research, such as to aid study recruitment. However, the provision at 45 CFR
164.512(i)(1)(ii) does not permit the researcher to remove protected health information from the covered entity's site. As
such, a researcher who is an employee or a member of the covered entity's workforce could use protected health information to
contact prospective research subjects. The preparatory research provision would allow such a researcher to identify prospective
research participants for purposes of seeking their Authorization to use or disclose protected health information for a research study.
Under the preparatory to research provision, a covered entity may permit a researcher who works for that covered entity to use PHI
for purposes preparatory to research. A covered entity may also permit, as a disclosure of PHI, a researcher who is not a workforce
member of that covered entity to review PHI (within that covered entity) for purposes preparatory to research.
16.1 
Are you requesting a Partial Waiver of HIPAA Authorization? 
Yes 
No
Why are you requesting a Partial Waviver?
Check yes or no. 
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16.2
Is the purpose of the Partial Waiver Recruitment (including screening of Medical
Records)? 
Yes 
No
Is the purpose of the Partial Waiver to request access to PHI for Non-MetroHealth
personnel? 
Yes 
No 
 
Check yes or no.  
16.3 
Will the use of Protected Health Information (PHI) involve more than minimal risk to
the privacy of the patients? 
Yes 
No
Check yes or no.  
16.4
The IRB as part of it's review of this request must have certain reassurances that
Patient Privacy will be protected, please respond to the following questions true or
false.
1.) The PHI will be used solely to facilitate the research protocol as an aid to study
recruitment or to expand the research study. The waiver would allow identification of
prospective research participants for the purpose of seeking authorization to use or
disclose PHI for a research study. Essentially, PHI will be used to identify and contact
potential research participants. Only contact and screening information (race, age,
medications, diagnosis, and primary physician) will be recorded, and no information
will leave the premises of MetroHealth Medical Center. The information will not be
disclosed outside the research group for this study. 
True 
False
2.) Information about potential subjects who are not interested in participating will be
destroyed after the patient declines enrollment. The information of patients choosing
to participate will be further used to schedule an appointment. As soon as the
research staff sees the participant, a full authorization will be obtained to collect, use
and disclose PHI for the remainder of the study. 
True 
False
3.) The PHI will not be reused or disclosed. Because the PHI belongs to individuals
who are not yet in the study, oversight provisions do not apply. After subjects are
formally enrolled, an authorization will be in effect and the waiver will no longer
apply. 
True 
False
Check true or false. 
16.5
If you did not answer true to all three parts of question 16.4 please explain: 
Please explain your response to
any statement where you have
entered false.
16.6
Please give a detailed explanation as to why this research activity cannot be
practicably conducted without a Partial Waiver or without access to PHI: 
While most candidates for the study are expected to be identifed via direct referral
from the investigators and their department colleagues, or via means whereby the
candidates initially contact us, some prospective candidates for the study could be
identified via review of the electronic medical record system.  
Candidates who agree to an Eligibility visit will be asked to sign a Consent and HIPAA
Authorization. 
Example: our study
population has xxx disease and
we rely on the EMR information
to identify and contact
potential subjects.
16.7
Who will have access to PHI? Please list below: 
Name
Employer
Department
Employer Name
John Chae
Metro
PM&R
The MetroHealth System
Amy Friedl
MetroHealth PM & R
The MetroHealth System
Kristine
Hansen
MHS
Physical Medicine and
Rehabilitation
Physical Medicine and
Rehabilitation
Terri Hisel
MHS
PM&R Research
Physical Medicine and
Rehabilitation
Richard
Wilson
Metro
PM&R
The MetroHealth System
Add the names of persons who
will have access to PHI. 
16.8
Are you or anyone who assists you Non-MetroHealth Personnel? 
Yes 
No
*Note all Non-MetroHealth Personnel have to go through employee orientation, have
a security clearance and Epic training before they can access the MetroHealth EMR.
Also all all Non-MetroHealth Personnel must work under the control of a member of
the MetroHealth Staff.
Check yes or no. 
If you filed a Prep for research
form with IT and RABO please
attach it here.
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Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
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 If you have previously completed an MHS Prep for Research form add that form
here: 
Name
Version
There are no items to display
Old Memos Requesting Partial Waivers (prior to 11/26/2010):
There are no items to display
Partial Wavier Memos
completed prior to 11/26/2010
will populate here.
View: 16-01 Request for a HIPAA Waiver of Authorization
16.1 Request For a HIPAA Waiver of Authorization:
16.9 
Are you requesting a Waiver of HIPAA Authorization? 
No
Check one, if you check no then hit continue and go to the next page.
If you are requesting a Waiver In order for the IRB to Grant a Waiver you
must answer questions 16.10-16.16
Check yes or no.
16.10
Disclosure of Protected Health Information (PHI) will not involve more
than minimal risk to the privacy of the patients/subjects: 
Check true or false.
16.11 
What is the plan to protect patient/subject identifiers from improper use
and disclosure? 
i.e. This unique identifier will be
used on the data collection
form. Only the PI will have
access to the key linking the
unique identifier to
patient/subject names.
16.12
What is the plan to destroy the identifiers at the earliest opportunity
consistent with the conduct of the research? 
i.e. The unique identifier key
will be retained in Red Cap and
will be destroyed two years
after the study ends.
16.13
Will PHI be reused or disclosed to others:  
Check yes or no.
16.14
Please complete the following: Data will only be used to analyze... 
i.e. Data will only be used to
analyze...
16.15
Describe why this research can not be conducted without a waiver: 
i.e because many of the
subjects who participate in this
treatment are dead or have
transferred to other treatment
modalities, or are transient. To
obtain HIPAA Authorization
from these individuals would be
a greater risk to their loss of
privacy.
16.16
Describe why this research could not be conducted without access to and
use of PHI: 
i.e. It would not be possible to
determine linkages between
.......and clinical outcomes
without the use of PHI.
View: 16-02 HIPAA II
16.2 HIPAA II:
16.11
Which of the following identifiers about subjects will be
collected for this study?
Name
Check all that apply, your answers
will help the IRB to determine if
your data is a limited data set.
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Name
2. Telephone Numbers
3. Address - Street
4. Address - Town or City
5. Address - State
6. Address - Zip Code
8. Names or Initials
11. Full face photographic images or comparable images
15. Medical device identifiers or serial numbers
16. Medical record or prescription numbers
18. Email addresses
20. Social Security Numbers
21. Dates (except year) related to an individual (birth date,
admission date, discharge date, date of death)
These Questions deal with the collection of data and data use
agreements. If you are not receiving data or sending data out
to another entity this does not apply to you. If you have a
signed contract with a sponsor or are in a cooperative group
that has a signed agreement with MHS this does not apply to
you. Data use agreements specify the conditions under which
data can be shared between MHS and other organizations or
individuals.
 16.12
If you have selected only numbers 4, 5, 6, or 22 in
question number 16.11 your research is considered to use
a limited data set. If either of the following conditions
apply, you will need to obtain a Data Use Agreement and
complete a waiver of authorization or obtain a HIPAA
authorization from the subjects. (check one): 
Name
There are no items to display
Check one, please read
carefully if you are not
receiving data or sending data
out to another entity this does
not apply to you, move on to
16.14. If you have a contract
with a sponsor or you are in a
cooperative group that has a
signed agreement with MHS
this does not apply to you. In
all other cases please
contact the MHS Legal
Department with questions
about data use agreements.
16.13
Attach a copy of the Data Use Agreement: 
Name
Description
There are no items to display
Attach Data Use Agreement.
View: 16-03 HIPAA III
16.3 HIPAA III:
16.14 
If any other unique identifying number, characteristic or code is selected,
please specify:
Please specify this question
refers back to the list of 22
identifiers.
16.15
If a link to an identifier will be used (i.e. code numbers) is selected, please
describe the coding mechanism that will be used: 
Coding mechanism will be associated with sequential enrollment. Numbers
will be preceded by the letters "DR". Thus, the enrolled subjects would be
numbered DR-01, DR-02, etc. 
Describe the coding
mechanism.
16.16 
Will a certificate of Confidentiality be obtained for this study? No 
Check yes or no. 
16.17
If yes, please attach a copy the Certificate of Confidentiality: 
Name
Version
There are no items to display
Attach a copy of the Certificate
of Confidentiality.
 16.18
Describe how you will protect the privacy of participants. Describe
specifically how you will gather information from or about them. Please
note while confidentiality concerns data, privacy concerns people. Example
People may be uncomfortable answering questions about their employer in
an open cubicle, so investigators may arrange for a more private location. 
Please note while confidentiality
concerns data, privacy concerns
people.  
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Subject screening, informed consent, and eligibility determination procedures as
well as medical histories will be conducted in a closed room with only the necessary
study personnel present. Device deployment and data collection procedures will be
done in labs with closed doors and only the necessary personnel present. 
View: 17-00 Waiver of Informed Consent
17.0  Request for a Waiver or Alteration of Informed Consent:
 17.1
Are you requesting a Waiver of Consent [45 CFR 46.116(d)] OR a Waiver of
Documentation of Consent [45 CFR 46.117 (c)].  
No  
If no hit continue button and you will go to the next page.
If yes please Note:
Note: Waivers of consent are not applicable if the research is subject to FDA
regulations, except the following. 
FDA Exception from general requirements:
1. Emergency Ues: Waivers of Informed Consent in FDA-regulated studies are
permissible in case of life-threatening situations, inability to communicate, not
sufficient time and no alternative method, even if research presents more
than minimal risk [21CFR50.23];
2. Planned Emergency Research: If the study satisfies the requirements under
21CFR50.24 “Exception from Informed Consent Requirements for Emergency
Research.”
Answer yes or no.
17.2
Waiver of Consent: If you are requesting a waiver of consent, please
provide the justification and address each of the following points for the
IRB's consideration: 
This research study involves no more than minimal risk: 
The waiver will not adversely affect the rights and welfare of the subjects: 
This research could not practicably be carried out without a waiver:
Whenever appropriate, the subjects will be provided with additional
pertinent information after participation: 
Yes 
No
Check true or false.
Note: practicably does not
mean it would be inconvenient.
17.3 
Please explain your answers to the above questions (You must provide the
IRB with enough information to make a decision): 
An IRB may waive the requirement to obtain a signed consent form for some
or all subjects if it ﬁnds either of the condiƟons below. In cases in which the
documentaƟon requirement is waived, the IRB may require the invesƟgator to
provide subjects with a wriƩen statement regarding the research.
Please explain in detail.
17.4
(1) The only record linking the subject and the research would be the
consent document and the principal risk would be potential harm resulting
from a breach of confidentiality. Each subject will be asked whether the
Check true or false.
Check yes or no.
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
NCT02928055

12/18/2020
Print: IRB16-00510 - PNS Dose for HSP
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17.5
subject wants documentation linking the subject with the research, and the
subject's wishes will govern; OR
(2) The research presents no more than minimal risk of harm to subjects and involves
no procedures for which wriƩen consent is normally required outside of the research
context.  
  
Yes 
No
 
17.6
If you are requesting any Alteration to the standard consent form/process
(written long form consent is the standard) please provide a detailed
explanation or plan.
 
Example of an alteration: verbal
consent.
View: 17-01 Informed Consent Process I
 
17.1  Informed Consent Process I:
 
17.7
Who will be approached to obtain consent/assent: 
Consent Method
Subjects will be asked to sign a study consent form after receiving a complete
explanation of the study.
 
Check all that apply.
 
 
 Idendtify all Staff obtaining consent on page 1 question 1.4 by selecting
the corresponding role.
 
 
 17.8
Subject Comprehension: What measures will be taken to ensure that
subjects fully understand the nature of their involvement in the research?
Note to Investigator: 
To address issues of comprehension on the part of the participant or
representative, and who is involved in obtaining consent, the answers to
following questions should be addressed:
1.)  Once a potential participant is identified, what process is
followed to inform the subject of the study prior to obtaining a
signature on the informed consent form?
a.    Who introduces the study to the potential subject?
b.    Who reviews the informed consent document in depth?
c.     Do you require the potential participant to have another person
present during the presentation of the study? 
2.)      Who answers the questions presented by the potential   
participant and/or family? 
3.)      What method is used to determine if the potential participant
fully understands the study, what is required from them, risk and
benefits, and their rights as a participant? 
4.)      Is the principal investigator usually present during the
presentation of the informed consent?
The study is first introduced in general terms by our Metro clinical staff listed on the
study (physicians, nurses, therapists). Physicians may cite the study during a
clinical visit if the patient seems appropriate. Nurses/Therapists may then follow-up
with the candidate. They also may introduce the study to a candidate who responds
to an ad or makes other inquiries. 
Typically the Clinical Coordinator conducts Consent/Eligibility Visits, reviews the ICF
in depth, and answers any questions presented by the candidate and/or their
caregiver(s). Candidates are not required to have another person present during the
presentation of the study, but they often do so. Typically, the PI and Co-
Investigators are not involved in the entire lengthy process but they would be
involved for a portion of eligibility determination and, as necessary, would address
questions that cannot be otherwise addressed.  
An ongoing dialogue takes place during the subject's introduction to the study and
the informed consent process to ensure that the candidate fully understands the
study, what is required from them, risk and benefits, and their rights as a
participant. Questions are encouraged and answered. In addition, after consent,
only subjects that obtain a score of ≥24 on the Mini Mental Status Examination will
be enrolled as it is used to determine the subject’s cognitive ability to understand
 
Please give brief explaination.
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the study requirements. 
See 17.10 for more details. 
 17.9
Capacity to Consent: How will capacity to consent be assessed? This
question is to be addressed for all subjects not just those with limited
decision making capacity. Identify who will make this assessment?
Suggested language....all subjects will be awake, alert and oriented, be
able to read etc. It is important to address issues like ability to read and
understand information in the consent.  
All subjects will be awake, alert, and oriented. Cognitive function is assessed as
described in the inclusion criteria. The PI or physician co-investigator will use their
clinical discretion in making the final determination. 
How will you determine
capacity to consent?
 17.10
Attach a description of the Consent Process: Explain the process of
obtaining consent from subjects. Under what settings and conditions will
consent be obtained? What will be the timing/waiting period? What
measures will be taken to ensure that subjects will make decisions
independently? Note to Investigator:  The “informed consent process” should
include sufficient time for the participant to review and consider participating
with the assistance of family members, research partners or representative if
necessary.  Other items to consider regarding time / waiting periods are:  Is the
potential participant given a copy of the consent form to read prior to the discussion
of the study?  Is it presented in person or mailed (where they can review it in the
privacy of their own home)? How much time elapses between the presentation of the
study and informed consent form and the actual signing of the form?  The answers to
these questions will ensure the PI has considered this component of the process and
will reassure the IRB that the PI is allowing adequate time for the participant to make
an informed decision and minimize the possibility of coercion or undue influence.  
Name
Description
Informed Consent Process (01-09-2009) | History
Attach a plan for consenting
subjects. This must give detail
about the consent process. 
 17.11
Parental Permission and Youth Assent: Complete this question only if
enrolling minors. How will parental permission and youth assent (if
applicable) be obtained?  
Give details of assent process
and assent form.
View: 17-02 Informed Consent Process II
17.2 Informed Consent Process II:
17.12 
What method will be used to document the consent process (i.e. a note in EPIC)? Not
how you will get consent only how you will document consent has been obtained, i.e
chart note, note in study file. 
Subjects will sign a consent form. The original consent form will be scanned into epic and placed in
the study file. EPIC will be used to schedule subjects and to document the informed consent
process. 
i.e chart note,
note in study
file.
17.13
What type of Informed Consent will be used in this study? (check all that apply): 
Consent Type
Written/Signed Consent by Subject
Video/Audio Consent Form
Check all that
apply
A non-return
cover memo
applies to a
study in which
you are sending
out a
questionnaire
with a memo or
letter that
informs
participants
about the study
but does not
need to be
signed and
returned. If
they complete
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and return the
questionnaire
they have given
consent.
17.14
If other, please specify: 
****Attach all consent forms (Informed Consent, Genetic Consent and HIPAA) here:****
If other,
please give
specifics. 
17.15
 Please attach a copy of each Informed Consent form(s) and HIPAA Authorization you are
using for this study: 
Name
Version
PNS Dose for HSP Consent 1.7 (2-May-2018, clean).doc
0.11
PNS Dose for HSP Consent 1.7 (2-May-2018,highlighted).doc
0.10
PNS Dose for HSP HIPAA 1.0 (21-Jul-2016)
0.01
PNS Dose for HSP HIPAA Alternative Means 1.0 (21-Jul-2016)
0.01
PNS Dose for HSP Video-Photo Consent 1.0 (21-Jul-2016)
0.01
Attach Consent
form(s) and
HIPAA
Authorization
here
17.16
Will non-English speaking subjects be enrolled? 
Yes  
No        Clear
If the answer to 17.17 is no we will not be enrolling non-English speaking subjects then
tell the IRB why not? 
Check one
Please give the
IRB an
explanation as
to why non-
English
speaking
subjects will not
be enrolled.
17.17
If non-English speaking subjects will be enrolled please provide information about the
person(s) obtaining consent (what language they will speak)and how you will deal with
written translation(s): 
Provide
information
about
translating
consents and
having
interpertative
services
available for
consent.
View: 18-00 Data Safety Monitoring I
Section 18.0 Data Safety Monitoring Plan
DATA AND SAFETY MONITORING PLAN GUIDE
WHEN DO YOU HAVE TO COMPLETE A DATA SAFETY MONITORING PLAN? 
FOR THE IRB- All intervenƟonal studies that are greater than minimal risk should have a Data Safety Monitoring Plan. The IRB reserves the right
to require a Data Safety Monitoring Plan for any study.
Archived IRB Data Plans - prior to 9/28/2010
FOR THE CRU-  ALL CRU PROTOCOLS [Recent NIH guidelines stipulate that all protocols that involve human
subjects, a signed consent form and are conducted on, or use the resources of, the CTSA Clinical Research
Unit - MHMC (CRU) are required to have a Data and Safety Monitoring Plan (DSM Plan).] 
What is a Data and Safety Monitoring Plan (DSM Plan)?
A DSM Plan is a prospectively defined strategy to assess the assumptions made in the trial design while the study is in progress.  Its main
purpose is to ensure the safety of participants in clinical research studies and the validity and integrity of research data collection. A properly
There is a significant amount of patient documentation (consent forms, manuals, 
questionnaires) that would require translation. Also, the research, and the necessary interaction 
with the study team, requires understanding of English. 
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designed DSM Plan improves the scientific quality and yield from a clinical trial and the protection of human subjects.
The DSM Plan needs to address the nature of the safety monitoring and who will be conducting that monitoring.  It may be reasonable for a single
individual to perform the monitoring in a small trial with minimal/low risk while a local independent or an external data and safety monitoring
board (DSMB) may be required for more complex/high risk trials.
Key elements to be incorporated in a DSM Plan
·
Assessment of risks and monitoring level
·
Safety contact: Who is responsible?
·
Safety monitoring: Who will do it? How often?
·
Informed consent process; consistency with the protocol
·
Data collection process
·
Adverse Events Monitoring: Anticipated and unanticipated
·
Description of anticipated adverse events
·
Grading and attribution method
·
Reporting of unanticipated adverse events
·
Plans for periodic reporting
·
Impact on termination of subjects from the study and study closure
Step 1 - only for Investigators Using the CRU:
1.A Is your protocol approved  and supported by the Ireland Cancer Center?
Yes 
No
If Yes - The Comprehensive Cancer Center Data and Safety Moniotoring Plan for Clinical Trials is on file.
Proceed to Step 5.1.B If No, Proceed and complete Steps 2-5
**********
Step 2 - all Investigators - Provide Information in order to determine the level of safety monitoring
required
2.A List all data collection types and study procedures (this information will pull from Section 8 Methods
and Procedures questions 8.1, 8.2, 8.3)
Data Collection types: 
Name
Audio-Recording/Video-Recording/Photographs
Chart Review - Prospective
Existing/Retrospective Data/Specimens
Interviews, questionnaires or psychological tests
Social-Behavioral Procedures: 
Name
Psychological Testing
Surveys/Questionnaires
Medical Procedures: 
Name
Collection of Biohazardous Substances
Study of Human Biological Materials (i.e. Urine Collection)
Investigation/Approved Devices
Study of Existing Data
Medical Tests, Comparisons, Evaluations
Clinical Assessments (EEG, EKG, SCID, etc.)
Venipuncture (Blood Draw)
Use of investigational devices
Psychological testing
**********
*You must select the risk level Please read the information below, check the applicable boxes and select
an appropriate risk level.
Level I: Minimal and Low Risk Studies (examples of studies that are minimal and low risk studies)
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Types of Studies: 
Name
Chart Review, interview, questionnaire
Level II: Moderate Risk Studies (examples of studies with populations, drugs, and procedures that are moderate
risk)
Types of Studies: 
Name
Elderly Population
Psychologically or neurologically impaired population
Level III: High Risk Studies (examples of diagnostic procedures and drugs or device studies which are high risk)
Types of Studies: 
Name
There are no items to display
2.B If you do not see your study procedures on the above list please add in the procedures being done for
research purposes:
 Add additional risk(s): 
Procedure
DSMB Risk
Outcomes Assessments (questionnaires, tests of arm and shoulder movement, pain thresholds)
Moderate
Percutaneous electrode implant procedure/short term implant and e-stim
Moderate
Percutaneous electrode removal
Minimal or Low
Venipuncture
Minimal or Low
X-Ray
Minimal or Low
Select the Appropriate Level of Risk for this study based on the criteria above:
 Level of Risk: 
Risk Level II Moderate Risk Studies
    Now Select the appropriate Level of Monitoring and give your justification:
2.C Rank Level of Monitoring (select one by checking the box)
    Minimal/Low/Moderate Levels of Monitoring 
     Justification for selecting Minimal/Low/Moderate Level of Monitoring Required: 
The most notable study procedure is the short-term percutaneous electrode implantation and electrical stimulation. As detailed later in
this application, the device is FDA Cleared via 510(k) and is being used in accordance with its labeling. Also, the researchers have
extensive experience with the associated procedures and risks, which are well tolerated by subjects. The risks are low, well understood
and well managed. Thus, the lower level of monitoring will be sufficient. 
     High Level of Monitoring 
     Justification for selecting Risk High Level of Monitoring: 
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View: 18-01 Data Safety Monitoring II
18.01 Data Safety Monitoring II
A designee will perform the safety monitoring: 
Yes 
No
Identify the designee [provide contact information]: 
At the study team level, the PI will have oversight. Safety monitoring at Metro also will be 
overseen by: Kristine Hansen, PT Study Coordinator
A medical monitor or independent individual/safety officer will be performing 
the safety assessments. 
Yes 
No
Identify who will be performing the safety assessments [provide contact
information]:  
King Ogbogu, MD will serve as an independent medical monitor for this study. 
Has a Data Safety Monitoring Board or Committee been established for this
study? 
Yes 
No
Identify these members by name, title and qualifications. How often will the
DSMB meet? How frequently will the DSMB report it's findings?) data prior to
9/28/2010 read only. 
If there is a DSMB or DSMC is it a nationally constituted Data and Safety
Monitoring Committee?   
Yes 
No
Please enter the Name of Contact or Chair, Address and Phone or E-Mail: 
Is there a locally constituted Data and Safety Monitoring Committee or Board
that will perform the safety monitoring. Specify composition and responsibilities
in the box below. Note: Board Members should not have conflicts with this study or
with study personnel. 
Yes 
No
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Names of Members of Local DSMB [provide contact information]: 
3.B.1 Description of anticipated adverse events. Pulled from question 10.5.
1) Risks associated with needle insertion for Sprint MicroLead placement
There are minor risks associated with inserting a Lead through the skin with a needle.
These risks are similar to the risks of any needle injection including the possibilities of
puncturing a blood vessel, irritating a nerve, and temporary bruising or pain at the
insertion site. The risks of puncturing a blood vessel and irritating a nerve are
uncommon, but the risks of temporary bruising and pain at the insertion site are
common. 
Some participants may experience a vasovagal (“fainting”) response due to the
discomfort or anxiety associated with of the procedure, especially among those with prior
history of “fainting.” This risk is rare and may be associated with symptoms of
lightheadedness, dizziness and or diaphoresis with concomitant reduction in blood
pressure and heart rate. For those with prior history of “fainting” the procedure will be
performed with the subject in the lateral decubitus position. 
To minimize the risks associated with percutaneously placing fine wire leads, only
appropriately trained physician investigators will perform the procedure. In addition, the
risk of excessive bleeding will be reduced by excluding candidates who are taking
warfarin with an INR > 3.0 and by placing manual pressure on the implantation site until
hemostasis is achieved. Finally, the risk of discomfort during the procedure will be
reduced by the use of an appropriate amount of local anesthetic. 
It is possible that, in some cases, multiple attempts may be required to achieve
appropriate placement of the Lead during the procedure. Each additional attempt at Lead
placement carries the same risks as the initial attempt described in this section.  
2) Risk of skin irritation, infection, or inflammation at the Sprint MicroLead exit site
There are risks of leaving a Sprint MicroLead in place for 4 weeks, including skin
irritation, infection, and granuloma formation (mild tissue inflammation) at the Lead exit
site. Symptoms include redness, swelling, or pain. The risk of skin irritation is common
while the risks of infection and granuloma formation are rare. 
These risks will be minimized by using sterile Leads and thoroughly cleansing the
insertion site with antibacterial solution at the time of insertion. The insertion site will be
covered with a dressing to keep it clean and dry, and the subjects and their caregivers
will be instructed to inspect the site for signs of infection or irritation regularly and to
inform the Investigator if they occur. If infection or skin irritation occurs, the Investigator
will administer an antibiotic and/or remove the Lead. Infections are rare and typically
resolve after Lead removal and antibiotic treatment. 
It should be noted that in a completed clinical trial of percutaneous intramuscular
electrical stimulation, one patient death occurred. The subject did not follow the
instructions for the care of the Lead exit site and also did not return for his scheduled
follow-up visit following electrode placement. He developed an electrode related infection
and was hospitalized. The cause of death is thought to be a myocardial infarction or a
pulmonary embolus, but the exact cause of the death and its relationship to the infection
are not known. To mitigate the potential risk of serious infection, a 48-72 hour safety
check will be performed after the procedure. Participants will return to the clinic and the
exit site will be evaluated for signs of infection. 
3) Risk of the Sprint MicroLead breaking beneath the skin
There is a possibility of a Lead breaking beneath the skin either during the course of the
study or during the procedure to remove Lead. This risk is uncommon. However, when a
Lead breaks, one or more Lead fragments usually remain in the body. The Investigator
will use clinical judgment to determine if the removal of such fragments is necessary.
Visual inspection of the Lead after it has been removed as well as x-rays will be used to
determine if any Lead fragments remain. The risk associated with the x-rays is no greater
than that associated with conventional clinical x-rays. If the Investigator determines a
Lead fragment has been retained in the body, he/she will determine what is medically
required to further evaluate and treat this retained fragment. Typically, no treatment is
required unless there are further sequelae, such as an infection or granuloma, associated
with the fragment. 
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The risk of leaving a Lead fragment is minimized by reducing the amount of time the
Lead remains implanted and the number of Leads implanted. In this protocol, a single
Sprint MicroLead will be implanted for just 4 weeks.  
4) Risk of infection associated with retained Sprint MicroLead fragments
A Lead fragment could result in the formation of a granuloma or infection. Although the
occurrence of a fragment-related infection or granuloma is uncommon an infection may
require removal of the Lead fragment and/or treatment with antibiotics. Investigators at
the Cleveland FES Center and Case Western Reserve University have over 30 years of
experience with dozens of research participants and hundreds of implanted leads like
those used in this study. Infections and granulomas of leads or lead fragments have been
uncommon, which is attributed to the materials and procedures that have been
developed as well as the extensive experience of the Investigators.. 
5) Risks associated with lead fragment removal
It is possible that a Lead fragment or fragments may be retained in the body following
removal of the Sprint MicroLead. If the Investigator determines that a lead fragment has
been retained, the Investigator will instruct the subject and his/her caregiver to carefully
inspect the Sprint MicroLead exit site and the surrounding skin in the weeks subsequent
to Lead removal. Subjects will be instructed to contact the Investigator if there are any
signs of pain, redness, swelling, discharge, or the appearance of a pimple-like mass (skin
abscess). Such signs indicate that the fragment has migrated to the skin surface. At that
time, if clinically warranted, the fragment may be removed via an outpatient procedure
which involves lancing the abscess and removing the fragment and application of a
topical antibiotic. 
The risks associated with the Lead fragment removal procedure include discomfort during
the procedure and skin irritation or infection in the area of the retained fragment. These
risks are rare. The risk of infection is mitigated by instructing the subject and/or his
caregiver to carefully monitor the site and immediately report any signs of infection. 
6) Risk of Lead Replacement due to Lead Migration or Lead Becoming Dislodged
It is possible that the Lead may migrate from its original intended location or that the
Lead may become dislodged (i.e. come out completely) during the treatment phase. This
risk is rare. If lead migration occurs, it is possible that the subject may experience
discomfort during stimulation (described further below under “risk of discomfort with
electrical stimulation”). If the Lead has migrated substantially or has come out, it may be
necessary to place another Lead. Each time an additional lead is placed, the subject has
an additional exposure to the same risks of lead placement described above in “risk of
needle insertion for Sprint MicroLead placement”. 
This risk of lead migration or the becoming dislodged is mitigated by instructions to the
subject and their caregiver, as appropriate, to ensure careful handling of the Lead and
Lead Connector during bandage changes. In addition, the risk of placing a new lead is
further mitigated by ensuring that Investigators are trained in the lead placement
procedure, ensuring that the shoulder tissue appears healthy prior to placing a new lead,
and collecting an additional INR blood sample for subjects who are taking warfarin. 
7) Risk of skin irritation under the Sprint Pad or bandages
It is possible that the skin could become irritated under the Sprint Pad. Additionally, there
may be skin irritation in the area surrounding the Lead insertion site, where an adhesive
bandage is taped to the skin. This risk is common; however, the bandages can be
changed to prevent the irritation from returning. 
The risks of skin irritation under the Sprint Pad (a modified surface electrode) and under
the bandages surrounding the Sprint MicroLead exit site will be reduced by excluding
patients with known sensitivity to skin surface electrodes and/or medical-grade adhesive
tapes. Subjects and their caregivers will be advised to examine the electrode exit site at
regular intervals to look for any signs of irritation. To avoid irritation under the Sprint
Pad, subjects will be advised that the Sprint Stimulator and Sprint Pad may be moved to
slightly different locations near the Lead insertion site throughout the treatment phase.
In addition, subjects will be instructed to avoid placing the Sprint Pad or bandages on
unhealthy skin. 
8) Risk of mechanical or electrical failure of the Sprint Stimulator
There is a rare chance that the Sprint Stimulator may malfunction. It is very unlikely that
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a stimulator malfunction will be harmful. If there is a problem with the Sprint Stimulator
or the Sprint MicroLead, the Stimulator will reset itself such that no stimulation is
delivered. 
The Sprint Stimulator will not deliver stimulation if it detects a high impedance level
indicating a broken lead wire or a faulty lead connection. Subjects will be instructed to
contact study staff in the event that an error message is displayed. 
9) Risks for pregnant women
The risk of harm to a pregnant woman or fetus is unknown. The device will not be used in
any subjects known to be pregnant. If a subject is known to become pregnant during the
treatment phase, stimulation will be stopped and the Sprint MicroLead will be removed. 
Potential risks of pregnancy will be reduced by administering a pregnancy test in females
of reproductive potential at study enrollment. Additionally, the Informed Consent form
will advise subjects that the risks of electrical stimulation during pregnancy are unknown
and that they should immediately notify the Investigator if they suspect they have
become pregnant during the study. 
10) Risk of discomfort due to electrical stimulation
Intramuscular electrical stimulation may be perceived by the subject as a tingling or
vibrating sensation, which may feel uncomfortable or painful. The risk of discomfort due
to stimulation is uncommon. At high stimulation intensities, shoulder pain may worsen. 
To minimize the risk of increased shoulder pain as the result of high intensity stimulation,
the Investigator will set an appropriate intensity for the stimulation. Should a subject feel
pain as the result of stimulation, he or she will be able to turn off the stimulation using
the Sprint Stimulator controls. Although muscle fatigue is unlikely with six hours of daily
stimulation therapy, subjects may also feel some discomfort if muscle fatigue occurs. If
muscle fatigue is observed, the Investigator is able to prescribe several shorter
stimulation sessions totaling six hours per day. 
Discomfort or pain due to stimulation may occur if the Sprint MicroLead migrates from its
original location. Stimulation near the skin surface may be perceived as a “pins and
needles” or stinging sensation and may be uncomfortable. 
The risk of pain due to a migrating electrode will be minimized by leaving stimulation off
until the Sprint MicroLead has had time to stabilize. The Sprint MicroLead has a fine wire
barb. In addition, the proximal portion of the Lead exits the skin which makes this Lead
more susceptible to becoming dislodged during bandage changes. As a conservative
measure, we allow one week for encapsulation of the Sprint MicroLead to ensure stability.
Data on the Lead has shown that electrodes are fully encapsulated by the surrounding
tissue. 
A tingling sensation may be felt under the Sprint Pad but this sensation is not expected to
be uncomfortable. If discomfort or pain is felt at the Sprint Pad site, the subject will be
instructed to turn off stimulation and move the Sprint Pad and Stimulator to a different
location. 
11) Risks associated with Diathermy
There is a risk of tissue damage if a subject undergoes diathermy. Shortwave or
microwave diathermy is a therapy that may be used to apply deep therapeutic heat for
the treatment of selected medical conditions such as relief of pain, muscle spasms, and
joint contractures. Diathermy can cause excessive heating of any implanted metal part
(including Leads), resulting in serious injury. The risk of tissue damage associated with
diathermy is rare. 
The risk of diathermy will be reduced by informing subjects that diathermy must not be
used. In addition, subjects will be informed to never undergo diathermy if a Sprint
MicroLead fragment remains in the body. 
12) Risks associated with MRI
Tissue damage may occur if a subject undergoes an MRI procedure while the Sprint
MicroLead, or a fragment of the Sprint MicroLead, is in the body. The risk of tissue
damage associated with MRI use is rare.  
Should a subject require a scheduled MRI during the treatment phase, the Sprint
MicroLead will be removed. The decision to remove any remaining fragments will depend
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on a careful assessment of the benefits of the MRI, risks of MRI with retained fragments
and risks associated with removing of electrode fragments. 
13) Risk of allergic reaction to local anesthetics and/or risk of accidental injection of local
anesthetic into a vein
There is a risk that the subject may have an allergic reaction to the local anesthetic used
during the treatment phase prior to insertion of the Sprint MicroLead. If the subject were
to have an allergic reaction, it would usually happen while the subject was still in the
clinic. If a subject complains of itching, difficulty breathing, lightheadedness and
dizziness, or a swollen tongue (common signs of an allergic reaction), appropriate
medical treatment will be administered. The risk of allergic reaction to local anesthetics is
rare. In addition, there is a risk of adverse central nervous system and/or cardiovascular
effects (including a rare risk that the subject’s heart can stop beating or that they could
stop breathing) if the local anesthetic is administered improperly. 
The risks of allergy to local anesthetic agents will be reduced by excluding subjects with a
prior known history of allergy or sensitivity to local anesthetic agents. In addition, prior
to the procedure, subjects will be advised of the signs and symptoms of an allergic
reaction. Because subjects will be awake during this procedure, they will be able to
verbalize any itching or other signs of allergy to the local anesthetic. The risks of
accidental intravascular injection of local anesthetic will be reduced by careful
administration of the local anesthetic. Careful administration includes ensuring that a vein
has not been punctured by the syringe prior to injecting the anesthetic and observing the
subject after the injection. In addition, the physical location of the anesthetic injection (in
the deltoid) combined with the injection technique would rarely result in an accidental
intravascular injection. 
14) Risk associated with venipuncture (if applicable)
The risks of drawing blood from a vein include discomfort at the site of puncture, possible
bruising and swelling around the puncture site, an infection, and faintness from the
procedure. The risks of discomfort, bruising, and swelling around the puncture site are
common while the risks of infection and fainting are rare. Blood sample collections are
only required in subjects taking warfarin.  
Subjects taking warfarin are at greater risk for developing bruises following venipuncture.
However, the risk of discomfort and bruising at that puncture site will be reduced by
applying gentle pressure following venipuncture as is the standard practice for collection
of blood samples. The rare risk of infection due to venipuncture will be reduced by using
proper blood collection technique including wiping the puncture site with an appropriate
cleansing solution.
Some subjects may experience a vasovagal (“fainting”) response due to the discomfort of
needle insertion or anxiety associated with the procedure. The risk of fainting will be
reduced by observing subjects during and following venipuncture to ensure that they feel
comfortable rising from their seated position. Subjects with a history of vasovagal
responses will be supine during venipuncture. 
15) Risk of worsening of pain symptoms
It is possible that the subject may have a worsening of pain symptoms or that they may
not obtain any therapeutic benefit from the treatment. The risk of worsening pain
symptoms is uncommon. In addition, subjects will have the opportunity to discontinue
treatment if their stimulation is too uncomfortable. 
These risks are mitigated by clinical training on the safe limits. Subjects do not have
access to make changes to the programming controls and thus could not advertently
change the value. 
16) Risks of Outcomes Assessments
The questionnaires and Fugl-Meyer Assessment present no risks. The assessments of
shoulder torque and kinematics may be slightly uncomfortable. The measures of central
sensitization (mechanical pain thresholds for hyperalgesia, pinprick pain thresholds for
hyperalgesia, temporal summation of repetitive pin-prick stimuli) may be slightly
uncomfortable and may cause brief skin irritation. The optional measures (tactile/touch,
vibration and thermal/thermal pain detection thresholds, temporal summation of
repetitive thermal stimuli, and Conditioned Pain Modulation (CPM)) also may be
uncomfortable and may cause brief skin irritation. 
17) Other
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Some of the survey questions present a rare risk of psychological harm. 
When PHI is involved there is the rare risk of a privacy breach. 
There may be other risks as yet unknown. 
Additional Comments on anticipated adverse events: 
3.B.2 Safety data/procedure used to preform evaluation:
Data to be evaluated: 
Name
Subject interview and/or contact
Subject's physical exam
Subject's symptoms or performance status
Interim Assessment of AE (e.g. midway, quarterly, semiannually, etc.)
Who will evaluate safety data: 
The PI and project staff meet at least quarterly to review all adverse events and study
data collected since the previous meeting. 
See attached DSMP. 
Frequency of Monitoring: 
Name
6 Months
3.C. Grading method and attribution for adverse event reporting:
Grading method and attribution for adverse event reporting
The PI must identify what scale will be used to grade adverse events (AEs)
and indicate his/her attribution/assessment of the relationship between the
adverse event and the protocol/intervention.  Each protocol may have a
unique approach to grading adverse events and the PI should consult the
parent protocol and/or funding source for specific grading scales. 
Suggested guidelines for the grading of adverse events are available
below:
Example A:  
 Cancer Therapy Evaluation Program (CTEP) Common Toxicity Criteria (CTC II)
available for viewing at http://ctep.info.nih.gov (see “Reporting Guidelines,
Common Toxicity Criteria”)
Example B:  Common grading scale
  0 
  No adverse event or within normal limits or not clinical
significant
  1  
  Mild AE, did not require treatment
  2  
  Moderate AE, resolved with treatment
3 
  Severe AE, resulted in inability to carry on normal activities
and required professional medical attention
  4 
  Life threatening or disabling AE
  5 
  Fatal AE
3.C.1 Identify the scale to be used to Grade AEs in this study:
CRU Safety Scale: 
Name
AEs will be graded using another system (specify and attach description).
3.C.2 Identify the attribution scale to be used in this study:
CRU Attribution Scale: 
Name
The PI will determine the relationships of AEs to test procedure/device/agent as not
related, possibly related, or definitely related, using standard criteria for clinical trials.
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3.D. Population being studied: (populated from your answers to Sections 11.00
and 12.00)
Vulnerable subject groups? Yes
Children? No
Decisionally Impaired Subjects? No
Pregnant Women and/or Fetuses? No
Will you be enrolling Prisoners? No
Other Populations being studied:
Vulnerable Populations
Poor / Uninsured
Elderly
Minorities
Cognitively Impaired
* Note More Frequent monitoring intervals may be needed for vulnerable
populations.
4.A. Plan for Adverse Event Reporting:
All Reportable Events (Anticipated and Unanticipated events) from this protocol
must be  submitted using the MHA eIRB Reportable event form in a timely
maner consistent with MHS IRB SOPs.
In addition to the MHS IRB adverse events and Uanticipated problems will be
reported to:
Reporting Institutions (check all that apply): 
Name
National Institutes of Health (NIH)
If other has been selected above please specify: 
4.B Stopping Rules or Conditions under which Subjects can be removed from the
Study [this information is from Section 10.01 of the Protocol Risks/Benefits
Questions
Are there defined Stopping Rules?   Yes
What are the stopping rules for the study? The study could be terminated at any
time for valid scientific reasons or reasons related to the protection of subjects
participating in this study. A reason for study termination includes but is not limited to
the discovery of an unexpected, significant, or unacceptable risk to the participants
enrolled in the study. 
What findings, events, or conditions would require a research subject to be
removed from the study? (i.e. disease progression) 
The research subject may be removed if they develop any condition during the course of
the study which would preclude the safe use of stimulation or otherwise impair their safe
participation in any study activity. 
4.D. Additional Information (if Applicable):
Provide any other information relevant to the data and safety monitoring plan
that was not already incorporated into this form.  
Attach A copy of your Data Safety Monitoring Plan or other relevant information
related to this form: 
Name
Version
PM&R Research Team Routine Study Safety Review Procedure
0.01
PNS Dose for HSP Monitoring Plan (17-Apr-2017)
0.03
View: 19-00 Use of Human Biological Materials In Research I
19.0 Use of Human Biological Materials In Research I:
 
19.1 
 
Check yes or no.
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Will Human Biological Materials be collected as part of this study? (i.e.
blood, tissue, fluids and substances etc.) 
Yes
If no, hit continue and you will be taken to the next page.
19.2
Will the storage or transportation of study materials place anyone at a
health risk? In other words, are these biohazardous materials? Will they put
the staff collecting them or transporting them at risk?  
No
Check yes or no. 
19.3 
If yes, please explain: 
Please explain the risks. Above
and beyond universal
precautions.
19.4
Will information from the materials be stored in an electronic database? 
Yes
Check yes or no.
19.5
If yes, list the database(s) where the information from the materials will be
stored and who will have access to them: 
Blood/urine samples will be collected to confirm eligibility for subjects when
necessary. Samples will be taken and tested at Metro using the standard clinical
procedures and Metro Lab. Results are made available via EPIC. 
List the database(s) and who
will have access to them.
19.6
Human Biological Material Destruction: please describe the plan for
materials destruction (when, where, how and by whom): 
Standard Metro Lab procedure. 
Give the destruction plan i.e.
shipped back to sponsor for
destruction at end of study,
incinerated by Browning Ferris 3
months after study ends.
19.7
Storage of Human Biological Materials: please describe where, how and for
how long the materials will be stored: 
Standard Metro Lab procedure. 
Physical storage of materials
where will it be, how will it be
stored and for how long.
View: 19-01 Use of Human Biological Materials in Research II
19.1 Use of Human Biological Materials In Research II:
19.8 
Does this research involve human cell/lines and/or products that are made
from human biological materials?   
Yes 
No
 If yes, please explain: 
Check Yes or No.
Please explain. 
19.9
Will Human Biological Materials (tissue, blood or salavia) be collected in
this study for genetic research? 
No
If Yes, please provide additional discussion of the genetic testing
components including who will conduct the tests: 
Check Yes or No. 
19.10 
If yes, can subject(s) decide not to participate in the genetic research and
still participate in the study? 
Check Yes or No. 
Please submit the appropriate genetic consent/tissue storage form and
attached at 17.15
A template for this form can be found on the IRB Home Page. Note: if tissue storage
is mandatory for participation in a study the subject consent must be included in
the body of the consent form; if it is not mandatory it can be included as a separate
page at the end of the consent form.  
19.11 
Will NIH Genome-Wide Association Studies (GWAS) be conducted? 
Yes 
No
Check Yes or No.
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
NCT02928055

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19.12
Will you be sending samples/data to the NIH GWAS? 
Yes 
No 
Check Yes or No. 
19.13 
Will you be using sample/data obtained frm the NIH GWAS?
Yes 
No
Check Yes or No. 
19.14
Please provide justification for using NIH GWAS: 
Please explain. 
If this is a GWAS study you will need to submit a Patient Information Sheet
(add at 17.16). This sheet should summarize the Genetic research component of
this study and tell the subjects where their biological materials will be sent, what
analysis they will undergo, who will have control of them and for how long and who
to contact if they want to withdraw their permission. It must be clear to subjects
that these samples will not be housed at MHS nor will the MHS Investigator retain
control over them.
View: 20-00 Drug Information I
20.0 Drug Information I:
20.1 
* Does this study involve drugs? No
If you are doing a drug study you may be required by law to register that
study at Clinical Trials.gov Section 113 of the FDA Modernization Act
mandates registration with ClinicalTrials.gov of investigational new drug
efficacy trials for serious diseases or conditions.  For more information click
on the link below:
http://prsinfo.clinicaltrials.gov/registering.pdf
If you answer no and hit continue you will go to the next section. 
Does this study involve:  
Is the study drug(s) FDA approved for this indication?   
Yes 
No
Does this study involve use of a Placebo?   
Yes 
No
Does this study have a drug washout period? 
Yes 
No 
Do you have an IND? 
Yes 
No 
If yes please give the IND: (include a copy of the FDA approval letter at
20.4) 
Who is the sponsor or holder of the IND? 
Does this study have an IND exemption? (include a copy of the FDA
exemption letter at 20.4)   
Yes 
No  
If you check no and hit
continue you will go to the next
page.
20.2 
Fill in an entry for all drugs that will be used in the study: 
Drug Name
FDA Approved (yes, no)
IND Number
Supplied By
There are no items to display
Please give a complete list.
20.3 
Manufacturer (name, address): 
Answer only if produced
commercially.
20.4
Attach a copy of:
1.) Investigator Brochure and/or Package Insert
2. FDA Form 1571 Investigational new Drug Application Form
3.) FDA Form 1572 Statement of the Investigator Form
4.) FDA Correspondence (i.e. FDA Approval Letter for IND, FDA
Exemption letter)
Name
Description
There are no items to display
Attach the IB, 1572 and 1571
here.
View: 21-00 Medical Device Information I rev
ID: IRB16-00510
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21.0 Medical Device Information I:
DeﬁniƟon of a Medical Device:
 An instrument, implement, machine, contrivance, implant, in vitro reagent, or other similar or related arƟcle,
including a component part, or accessory which is
• 
Intended for use in the diagnosis of disease or other condiƟons, or in the cure, miƟgaƟon, treatment or
prevenƟon of disease in man or other animals.
• 
Intended to aﬀect the structure or any funcƟon of the body of man or other animals, and which does not achieve
any of its primary intended purposes through chemical acƟon within or on the body of man or other animals and
which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
In short any health care product that does not achieve its primary intended purposes by chemical acƟon or by being
metabolized. Medical devices include, among other things, surgical lasers, wheelchairs, sutures, pacemakers,
vascular graŌs, intraocular lenses, and orthopedic pins. Medical devices also include diagnosƟc aids such as
reagents and test kits for in vitro diagnosis (IVD) of disease and other medical condiƟons such as pregnancy.
21.1
Is this a Medical Device Study? Yes
If you are doing a device study you may be required by law to register that
study at Clinical Trials.gov Section 113 of the FDA Modernization Act
mandates registration with ClinicalTrials.gov of investigational new device
efficacy trials for serious diseases or conditions.  For more information click
on the link below:
http://prsinfo.clinicaltrials.gov/registering.pdf
If you answer no and hit continue you will go to the next section. 
Answer yes or no.
21.2 
Medical Device Generic Name: 
Peripheral Nerve Stimulator
Give generic name. 
21.3
21.4
Medical Device Brand Name: 
The Sprint PNS System
Medicare Code Number: 
N/A 
As stated in regulations 21 CFR 812.3(m), a device may be considered a,
Significant Risk Device, if it meets any of the following criteria and a
determination is made by the IRB that the device presents a potential for
serious risk to the health, safety or welfare of a subject.
Give brand name. 
21.5 
Is this device intended as an implant? No
Check one
21.6
Is device to be used in supporting or sustaining human life? No
Check one
21.7
Is the device for use of substantial importance in diagnosing, curing,
mitigating, or treating disease or otherwise preventing impairment of
human health?  
No
Check one
21.8
Does this device present a potential for serious risk to the health, safety, or
welfare of a subject?  
No
Check one
21.9
If you answered NO to all the above, or if an initial risk assessment has
determined that this is a non-significant risk device (21CFR 812.3), attach
the appropriate documentation for this justification:  
Name
Description
There are no items to display
Attach justification. 
 
21.10
What is the regulatory status of the study device?  
 
Provide information on the
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Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
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FDA Cleared via 510(k) and used in accordance with its labeling (thus exempt from
IDE regulation).
regulatory status of the device.
21.11
What is the long term plan for device management once the study closes? 
Devices are not retained by subjects beyond the Treatment Phase. 
Provide information such as
how you will communicate
important information to
subject; plan for
maintenance/repairs; contact
information besides the PI.
View: 21-01 Medical Device Information II
21.1 Medical Device Information II:
21.12 
What is the FDA Approval date? 
6/26/2017 
Please give date. 
21.13
What is the Premarket Approval (PMA)number? 
N/A
Please give number.
21.14 
What is the Premarket Notification (510K) number? 
K170902 
Please give number.
21.15
What is the Investigational Device Exemption (IDE) number? 
N/A
Who is the sponsor or holder of the IDE? 
Please give IDE number if
applicable.
21.16
What is the Humanitarian Device Exemption (HDE) number? 
N/A  
Please give HDE number if
applicable.
21.17
Has this medical device ever been used in animals? 
No   
Check one
21.18
If yes, please give a brief summary of the results of studies involving
animals: 
Give a brief summary or attach
one below at 22.16.
21.19
Please attach supporting documents: 
Name
Description
K170902 Documentation | History
Sprint PNS System Device Description | History
Give a brief summary.
View: 21-02 Medical Device Information III
21.2 Medical Device Information III:
21.20 
 Has this medical device ever been used in humans? Yes 
Check yes or no.
21.21
If yes, please give a brief summary of the results from studies involving
humans:  
Note: The Smartpatch System discussed here has been renamed the Sprint
PNS System subsequent to FDA clearance. 
Principals of SPR Therapeutics (a subsidiary of NDI Medical) and NDI
Medical have been involved in the study of peripheral nerve stimulation
through percutaneous lead placement for the treatment of post-stroke
shoulder pain for more than a decade. Current SPR and NDI staff
participated in sponsoring and managing the published studies (led by Dr.
John Chae, who continues these studies and is an advisor to SPR) described
below. Using the identical Smartpatch Lead and identical stimulus
parameters, percutaneous peripheral nerve stimulation for the treatment of
post-stroke shoulder pain has been evaluated in multiple studies at Case
Western Reserve University by Chae and associates.  
Yu, Chae, and colleagues conducted a double-blind crossover trial to
determine whether sensation associated with percutaneous electrical
stimulation is less painful than sensation associated with surface electrical
stimulation. Subjects rated the pain of each treatment modality using a VAS
and the Pain Rating Index of the McGill Pain Questionnaire. The median
scores on the VAS and the Pain Rating Index were lower for percutaneous
Give a brief summary.
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
NCT02928055

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electrical stimulation than for surface electrical stimulation (p=0.007 and
p=0.018, respectively), indicating less pain with percutaneous electrical
stimulation. In addition, nine out of ten subjects stated that they would
prefer to receive percutaneous electrical stimulation over surface electrical
stimulation. 
A case report of a chronic stroke patient suffering from shoulder
subluxation and pain, who was unable to tolerate surface electrical
stimulation, suggested initial clinical feasibility of six weeks of
percutaneous peripheral nerve stimulation for the treatment of post-stroke
shoulder pain. The authors, including current SPR staff, then conducted an
exploratory case series in which eight chronic stroke survivors received six
weeks of percutaneous electrical stimulation to their posterior deltoid and
supraspinatus muscles. Subjects experienced a significant improvement in
subluxation and self-reported pain. Furthermore, this study also
demonstrated significant improvement in pain related quality of life based
on the pain domain of SF-36. 
Yu, Chae and associates, including current SPR and NDI staff, then went on
to enroll 61 subjects into a multi-center single-blinded randomized
controlled study to assess the safety and effectiveness of percutaneous
electrical stimulation for post-stroke shoulder pain. To qualify for
participation in the study, subjects had to be more than 12 weeks post
stroke and rate their shoulder pain as at least a 2 on the pain intensity
question of the Brief Pain Inventory, which is an 11-point numeric rating
scale that asks subjects to rate their worst shoulder pain in the last week.
Treatment subjects had four percutaneous leads placed in the posterior
deltoid, middle deltoid, supraspinatus, and upper trapezius muscles. They
were instructed to keep stimulation ON for a total of 6 hours a day during
the 6-week treatment period. Control subjects were given a cuff type sling
to use whenever the hemiplegic arm was unsupported during the 6-week
treatment period and permitted to continue other pain therapies such as
PT, OT, and medications. 
Subjects were assessed at baseline, at 3-weeks, at EOT, and at 3-, 6-, and
12-months post-EOT. The primary outcome measure was the same as in the
present study (BPI pain intensity). However, these data were collected on
the BPI form rather than a subject diary. Secondary measures included the
same Pain Interference Question of the BPI (BPI 9) as is planned for use in
the present study and a variety of physical functioning assessments,
including pain-free passive external rotation range of motion (ROM) of the
glenohumeral joint.
The group receiving electrical stimulation demonstrated a significantly
higher success rate (as measured by a minimum 2-point reduction on the
scale) than the control group (84% vs. 31%, p=.001 at the end of
treatment; and 63% vs. 21%, p=.001 for all follow-up visits). In addition,
34% (11 subjects) of the group receiving electrical stimulation were pain
free (reported “0”, indicating no pain) at the EOT compared to only 3.4%
(one subject) in the control group. 
The 32 subjects randomized to the treatment group each had four
percutaneous leads placed that were identical to the Smartpatch Lead. The
lead placement procedure was well tolerated. All leads remained intact and
free of infection during the 7-week indwelling period. Of the 128 leads
placed in this study, the tips of five leads (3.9%) among four subjects
(12.5%) broke during removal, none of which resulted in an adverse event.
Granuloma formation defined as localized tissue inflammation exhibited by
redness, swelling, or pain at the lead exit site was noted for five leads
(3.9%) in two subjects (6.3%). All granulomas resolved after lead removal
with no further intervention required. 
The authors concluded that percutaneous electrical stimulation is safe and
effective in reducing post-stroke shoulder pain, with sustained pain
reduction in a cohort of subjects to at least 12 months after the end of
treatment. Placement of leads in proximity to peripheral nerves within
target muscles bypasses cutaneous pain receptors, which minimizes the
discomfort of stimulation and ensures stable electrode placement. Further,
once placed, skilled personnel are not needed on a daily basis to place
electrodes to ensure effective positioning. 
In an IRB approved Non Significant Risk (NSR) study, eight chronic stroke
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survivors with post-stroke shoulder pain, five with subluxation and three
without, received three weeks of peripheral nerve electrical stimulation, 6-
hrs daily via a single Smartpatch Lead placed between the motor points of
the middle and posterior deltoids, which produced strong contractions of
both muscles. The primary outcome measure was pain intensity (BPI 3) on
the short form of the BPI. Longitudinal analysis demonstrated that
participants experienced significant reduction in pain intensity. Participants
also experienced significant reduction in pain interference with daily
activities based on BPI 9 (F=5.9, p<0.01), and significant improvement in
QoL based on the bodily pain component of the SF-36 (F=12.8, p<0.001).
All 8 participants exhibited significant pain reduction at EOT. This study
indicated that the three-week, single-lead approach produced pain relief
comparable to the more complex six week, 4-lead approach. The three
participants without subluxation all exhibited substantial pain reduction,
which reinforced that pain reduction is not mediated by improvements in
subluxation and that subluxation is the not a necessary inclusion criterion. 
Additional testing was conducted in 5 subjects to validate the design of the
Smartpatch Stimulator and other external components. This design
validation of a non-stimulating Smartpatch System provided evidence that
the Smartpatch System meets user needs regarding usability and comfort.
Physical aspects of system usage, such as making cable connections,
attachment between Stimulator and Pad, and attachment to the skin, were
reported as easy and acceptable. Software aspects of the Smartpatch
Stimulator usage, such as starting and stopping stimulation, identifying the
battery level, and adjusting stimulus intensity were all reported as easy
and acceptable. 
Furthermore, a stimulating Smartpatch System has been used by 3 subjects
to date in an ongoing IDE study being conducted under G090085. In this
protocol, the system is used in the Trial Stage for determining eligibility for
our implantable system. All three subjects completed the Trial Stage and
were able to use the Smartpatch components successfully to deliver their
stimulation therapy. Subjects completed satisfaction surveys upon
completion of Smartpatch System use. All three subjects reported that it
was easy to understand how to use the Smartpatch System and that the
System was easy to operate. Two subjects reported that the pad wasn’t
sticky enough, sometimes causing them to use more than one Pad per day.
Subjects in the proposed study will be given more guidance on the proper
preparation of the skin to ensure pad adhesion. The subjects reported that
the covering bandages used were of an acceptable adhesion and size, but
two subjects reported that the Lead Connector Tapes were difficult to use.
All three subjects reported that the system as comfortable, “not at all”
bothersome to wear, and that they were comfortable going out in public
with the system on. The subjects reported that they were satisfied with
their experience in the study, felt that the study had a positive impact on
their lives, and would recommend participation in the study to a friend. 
21.22 
Please list all research personnel authorized to use the study device: 
Name
Employer Department
Employer Name
John Chae
Metro
PM&R
The MetroHealth System
Kristine
Hansen
MHS
Physical Medicine and
Rehabilitation
Physical Medicine and
Rehabilitation
Margaret
Maloney
MHS
SCI Consortium
The MetroHealth System
Gregory
Naples
Metro
Physical Medicine and
Rehabilitation
Case Western Reserve
University
Richard Wilson Metro
PM&R
The MetroHealth System
List all research personnel
authorized to use study device.
21.23 
How will this medical device be used in research? 
Percutaneous PNS System: The Sprint PNS System (SPR Therapeutics, Cleveland,
OH) will be used to deliver the PNS therapy. The System consists of a small external
stimulator, percutaneous lead, and pad. The external stimulator “snaps” on to the
pad. The pad has an embedded power source for the System but also serves as the
anode. The pad is replaced regularly based on treatment parameters, allowing the
investigative team to prescribe the total dosage based upon the number of pads.
The single-channel stimulator outputs a biphasic current waveform with current
pulse parameter ranges that are suitable for PNS. These electrodes have been used
extensively to deliver percutaneous PNS to shoulder muscles. [6-12,62,71] 
Lead Placement Procedure:  
Give a brief description.
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Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
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The procedure will be performed under a sterile condition. The location and depth of
the electrode implant site are determined by monopolar needle stimulation with
demonstration of strong contraction of both the middle and posterior deltoid
muscles. [6,9,62,70] The introducer loaded with the lead is inserted perpendicular
to the skin surface and advanced to the depth (3-4 cm) defined by the monopolar
test stimulation. The introducer is then withdrawn with the electrode retained in the
muscle by a barb at its tip. 
PNS Treatment Protocol: 
After one week for lead stabilization [80], the Sprint PNS System will be
programmed for stimulation. Based on over 30-yrs of experience, the Cleveland FES
Center established parameters for safe and effective delivery of PNS (pulse
frequency = 12 Hz; pulse amplitude = 20 mA; pulse duration = 5-200 usec (set by
clinician); duty cycle = 2-sec ramp-up, 16-sec plateau, 2-sec ramp down, 10 sec
off; daily dose = 6 hrs/day). [81] These parameters provide strong fused
comfortable muscle contraction with minimal fatigue. [6-12,49,62,71,82-84]
Stimulation frequency and amplitude are fixed. The pulse duration is set to produce
strong, comfortable contraction of both the middle and posterior deltoids. A
balanced biphasic waveform allows an equal amount of current to flow in either
phase, creating a safe net zero charge. [85] In this dose-response study,
participants receive 3h, 6h, or 9h of stimulation each day. The stimulator keeps an
electronic log for compliance monitoring. 
Electrode and Electrode Site Surveillance and Electrode Removal: All caregivers and
participants will be trained in the assessment of electrode site and the daily
placement of the Sprint Pad. The caregiver conducts daily inspections to detect
complications. The nurse coordinator inspects the site for infection and performs
motor/sensory threshold testing for lead migration and lead integrity, respectively,
at the following times: within 48-72 hrs of lead placement, at the beginning of PNS
treatment, and at the end of treatment. Inspection and testing of motor/sensory
thresholds and impedance may also occur anytime during the 3-wk PNS treatment
period as deemed necessary. At the end of treatment, the electrode is removed by
gently pulling on the external portion. All participants undergo radiographic
surveillance for retained electrode fragments. 
21.24
Please list all possible complications: 
Complications are addressed in the Risks for the Study (duplicated from 10.5): 
1) Risks associated with needle insertion for Sprint MicroLead placement
There are minor risks associated with inserting a Lead through the skin with a
needle. These risks are similar to the risks of any needle injection including the
possibilities of puncturing a blood vessel, irritating a nerve, and temporary bruising
or pain at the insertion site. The risks of puncturing a blood vessel and irritating a
nerve are uncommon, but the risks of temporary bruising and pain at the insertion
site are common. 
Some participants may experience a vasovagal (“fainting”) response due to the
discomfort or anxiety associated with of the procedure, especially among those with
prior history of “fainting.” This risk is rare and may be associated with symptoms of
lightheadedness, dizziness and or diaphoresis with concomitant reduction in blood
pressure and heart rate. For those with prior history of “fainting” the procedure will
be performed with the subject in the lateral decubitus position. 
To minimize the risks associated with percutaneously placing fine wire leads, only
appropriately trained physician investigators will perform the procedure. In addition,
the risk of excessive bleeding will be reduced by excluding candidates who are
taking warfarin with an INR > 3.0 and by placing manual pressure on the
implantation site until hemostasis is achieved. Finally, the risk of discomfort during
the procedure will be reduced by the use of an appropriate amount of local
anesthetic. 
It is possible that, in some cases, multiple attempts may be required to achieve
appropriate placement of the Lead during the procedure. Each additional attempt at
Lead placement carries the same risks as the initial attempt described in this
section.  
2) Risk of skin irritation, infection, or inflammation at the Sprint MicroLead exit site
There are risks of leaving a Sprint MicroLead in place for 4 weeks, including skin
List all complications.
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irritation, infection, and granuloma formation (mild tissue inflammation) at the Lead
exit site. Symptoms include redness, swelling, or pain. The risk of skin irritation is
common while the risks of infection and granuloma formation are rare. 
These risks will be minimized by using sterile Leads and thoroughly cleansing the
insertion site with antibacterial solution at the time of insertion. The insertion site
will be covered with a dressing to keep it clean and dry, and the subjects and their
caregivers will be instructed to inspect the site for signs of infection or irritation
regularly and to inform the Investigator if they occur. If infection or skin irritation
occurs, the Investigator will administer an antibiotic and/or remove the Lead.
Infections are rare and typically resolve after Lead removal and antibiotic treatment. 
It should be noted that in a completed clinical trial of percutaneous intramuscular
electrical stimulation, one patient death occurred. The subject did not follow the
instructions for the care of the Lead exit site and also did not return for his
scheduled follow-up visit following electrode placement. He developed an electrode
related infection and was hospitalized. The cause of death is thought to be a
myocardial infarction or a pulmonary embolus, but the exact cause of the death and
its relationship to the infection are not known. To mitigate the potential risk of
serious infection, a 48-72 hour safety check will be performed after the procedure.
Participants will return to the clinic and the exit site will be evaluated for signs of
infection. 
3) Risk of the Sprint MicroLead breaking beneath the skin
There is a possibility of a Lead breaking beneath the skin either during the course of
the study or during the procedure to remove Lead. This risk is uncommon. However,
when a Lead breaks, one or more Lead fragments usually remain in the body. The
Investigator will use clinical judgment to determine if the removal of such fragments
is necessary. Visual inspection of the Lead after it has been removed as well as x-
rays will be used to determine if any Lead fragments remain. The risk associated
with the x-rays is no greater than that associated with conventional clinical x-rays. If
the Investigator determines a Lead fragment has been retained in the body, he/she
will determine what is medically required to further evaluate and treat this retained
fragment. Typically, no treatment is required unless there are further sequelae, such
as an infection or granuloma, associated with the fragment. 
The risk of leaving a Lead fragment is minimized by reducing the amount of time the
Lead remains implanted and the number of Leads implanted. In this protocol, a
single Sprint MicroLead will be implanted for just 4 weeks.  
4) Risk of infection associated with retained Sprint MicroLead fragments
A Lead fragment could result in the formation of a granuloma or infection. Although
the occurrence of a fragment-related infection or granuloma is uncommon an
infection may require removal of the Lead fragment and/or treatment with
antibiotics. Investigators at the Cleveland FES Center and Case Western Reserve
University have over 30 years of experience with dozens of research participants
and hundreds of implanted leads like those used in this study. Infections and
granulomas of leads or lead fragments have been uncommon, which is attributed to
the materials and procedures that have been developed as well as the extensive
experience of the Investigators.. 
5) Risks associated with lead fragment removal
It is possible that a Lead fragment or fragments may be retained in the body
following removal of the Sprint MicroLead. If the Investigator determines that a lead
fragment has been retained, the Investigator will instruct the subject and his/her
caregiver to carefully inspect the Sprint MicroLead exit site and the surrounding skin
in the weeks subsequent to Lead removal. Subjects will be instructed to contact the
Investigator if there are any signs of pain, redness, swelling, discharge, or the
appearance of a pimple-like mass (skin abscess). Such signs indicate that the
fragment has migrated to the skin surface. At that time, if clinically warranted, the
fragment may be removed via an outpatient procedure which involves lancing the
abscess and removing the fragment and application of a topical antibiotic. 
The risks associated with the Lead fragment removal procedure include discomfort
during the procedure and skin irritation or infection in the area of the retained
fragment. These risks are rare. The risk of infection is mitigated by instructing the
subject and/or his caregiver to carefully monitor the site and immediately report any
signs of infection. 
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6) Risk of Lead Replacement due to Lead Migration or Lead Becoming Dislodged
It is possible that the Lead may migrate from its original intended location or that
the Lead may become dislodged (i.e. come out completely) during the treatment
phase. This risk is rare. If lead migration occurs, it is possible that the subject may
experience discomfort during stimulation (described further below under “risk of
discomfort with electrical stimulation”). If the Lead has migrated substantially or has
come out, it may be necessary to place another Lead. Each time an additional lead
is placed, the subject has an additional exposure to the same risks of lead
placement described above in “risk of needle insertion for Sprint MicroLead
placement”. 
This risk of lead migration or the becoming dislodged is mitigated by instructions to
the subject and their caregiver, as appropriate, to ensure careful handling of the
Lead and Lead Connector during bandage changes. In addition, the risk of placing a
new lead is further mitigated by ensuring that Investigators are trained in the lead
placement procedure, ensuring that the shoulder tissue appears healthy prior to
placing a new lead, and collecting an additional INR blood sample for subjects who
are taking warfarin. 
7) Risk of skin irritation under the Sprint Pad or bandages
It is possible that the skin could become irritated under the Sprint Pad. Additionally,
there may be skin irritation in the area surrounding the Lead insertion site, where
an adhesive bandage is taped to the skin. This risk is common; however, the
bandages can be changed to prevent the irritation from returning. 
The risks of skin irritation under the Sprint Pad (a modified surface electrode) and
under the bandages surrounding the Sprint MicroLead exit site will be reduced by
excluding patients with known sensitivity to skin surface electrodes and/or medical-
grade adhesive tapes. Subjects and their caregivers will be advised to examine the
electrode exit site at regular intervals to look for any signs of irritation. To avoid
irritation under the Sprint Pad, subjects will be advised that the Sprint Stimulator
and Sprint Pad may be moved to slightly different locations near the Lead insertion
site throughout the treatment phase. In addition, subjects will be instructed to avoid
placing the Sprint Pad or bandages on unhealthy skin. 
8) Risk of mechanical or electrical failure of the Sprint Stimulator
There is a rare chance that the Sprint Stimulator may malfunction. It is very unlikely
that a stimulator malfunction will be harmful. If there is a problem with the Sprint
Stimulator or the Sprint MicroLead, the Stimulator will reset itself such that no
stimulation is delivered. 
The Sprint Stimulator will not deliver stimulation if it detects a high impedance level
indicating a broken lead wire or a faulty lead connection. Subjects will be instructed
to contact study staff in the event that an error message is displayed. 
9) Risks for pregnant women
The risk of harm to a pregnant woman or fetus is unknown. The device will not be
used in any subjects known to be pregnant. If a subject is known to become
pregnant during the treatment phase, stimulation will be stopped and the Sprint
MicroLead will be removed. 
Potential risks of pregnancy will be reduced by administering a pregnancy test in
females of reproductive potential at study enrollment. Additionally, the Informed
Consent form will advise subjects that the risks of electrical stimulation during
pregnancy are unknown and that they should immediately notify the Investigator if
they suspect they have become pregnant during the study. 
10) Risk of discomfort due to electrical stimulation
Intramuscular electrical stimulation may be perceived by the subject as a tingling or
vibrating sensation, which may feel uncomfortable or painful. The risk of discomfort
due to stimulation is uncommon. At high stimulation intensities, shoulder pain may
worsen. 
To minimize the risk of increased shoulder pain as the result of high intensity
stimulation, the Investigator will set an appropriate intensity for the stimulation.
Should a subject feel pain as the result of stimulation, he or she will be able to turn
off the stimulation using the Sprint Stimulator controls. Although muscle fatigue is
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
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unlikely with six hours of daily stimulation therapy, subjects may also feel some
discomfort if muscle fatigue occurs. If muscle fatigue is observed, the Investigator is
able to prescribe several shorter stimulation sessions totaling six hours per day. 
Discomfort or pain due to stimulation may occur if the Sprint MicroLead migrates
from its original location. Stimulation near the skin surface may be perceived as a
“pins and needles” or stinging sensation and may be uncomfortable. 
The risk of pain due to a migrating electrode will be minimized by leaving
stimulation off until the Sprint MicroLead has had time to stabilize. The Sprint
MicroLead has a fine wire barb. In addition, the proximal portion of the Lead exits
the skin which makes this Lead more susceptible to becoming dislodged during
bandage changes. As a conservative measure, we allow one week for encapsulation
of the Sprint MicroLead to ensure stability. Data on the Lead has shown that
electrodes are fully encapsulated by the surrounding tissue. 
A tingling sensation may be felt under the Sprint Pad but this sensation is not
expected to be uncomfortable. If discomfort or pain is felt at the Sprint Pad site, the
subject will be instructed to turn off stimulation and move the Sprint Pad and
Stimulator to a different location. 
11) Risks associated with Diathermy
There is a risk of tissue damage if a subject undergoes diathermy. Shortwave or
microwave diathermy is a therapy that may be used to apply deep therapeutic heat
for the treatment of selected medical conditions such as relief of pain, muscle
spasms, and joint contractures. Diathermy can cause excessive heating of any
implanted metal part (including Leads), resulting in serious injury. The risk of tissue
damage associated with diathermy is rare. 
The risk of diathermy will be reduced by informing subjects that diathermy must not
be used. In addition, subjects will be informed to never undergo diathermy if a
Sprint MicroLead fragment remains in the body. 
12) Risks associated with MRI
Tissue damage may occur if a subject undergoes an MRI procedure while the Sprint
MicroLead, or a fragment of the Sprint MicroLead, is in the body. The risk of tissue
damage associated with MRI use is rare.  
Should a subject require a scheduled MRI during the treatment phase, the Sprint
MicroLead will be removed. The decision to remove any remaining fragments will
depend on a careful assessment of the benefits of the MRI, risks of MRI with
retained fragments and risks associated with removing of electrode fragments.
13) Risk of allergic reaction to local anesthetics and/or risk of accidental injection of
local anesthetic into a vein
There is a risk that the subject may have an allergic reaction to the local anesthetic
used during the treatment phase prior to insertion of the Sprint MicroLead. If the
subject were to have an allergic reaction, it would usually happen while the subject
was still in the clinic. If a subject complains of itching, difficulty breathing,
lightheadedness and dizziness, or a swollen tongue (common signs of an allergic
reaction), appropriate medical treatment will be administered. The risk of allergic
reaction to local anesthetics is rare. In addition, there is a risk of adverse central
nervous system and/or cardiovascular effects (including a rare risk that the subject’s
heart can stop beating or that they could stop breathing) if the local anesthetic is
administered improperly. 
The risks of allergy to local anesthetic agents will be reduced by excluding subjects
with a prior known history of allergy or sensitivity to local anesthetic agents. In
addition, prior to the procedure, subjects will be advised of the signs and symptoms
of an allergic reaction. Because subjects will be awake during this procedure, they
will be able to verbalize any itching or other signs of allergy to the local anesthetic.
The risks of accidental intravascular injection of local anesthetic will be reduced by
careful administration of the local anesthetic. Careful administration includes
ensuring that a vein has not been punctured by the syringe prior to injecting the
anesthetic and observing the subject after the injection. In addition, the physical
location of the anesthetic injection (in the deltoid) combined with the injection
technique would rarely result in an accidental intravascular injection. 
14) Risk associated with venipuncture (if applicable)
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The risks of drawing blood from a vein include discomfort at the site of puncture,
possible bruising and swelling around the puncture site, an infection, and faintness
from the procedure. The risks of discomfort, bruising, and swelling around the
puncture site are common while the risks of infection and fainting are rare. Blood
sample collections are only required in subjects taking warfarin.  
Subjects taking warfarin are at greater risk for developing bruises following
venipuncture. However, the risk of discomfort and bruising at that puncture site will
be reduced by applying gentle pressure following venipuncture as is the standard
practice for collection of blood samples. The rare risk of infection due to
venipuncture will be reduced by using proper blood collection technique including
wiping the puncture site with an appropriate cleansing solution. 
Some subjects may experience a vasovagal (“fainting”) response due to the
discomfort of needle insertion or anxiety associated with the procedure. The risk of
fainting will be reduced by observing subjects during and following venipuncture to
ensure that they feel comfortable rising from their seated position. Subjects with a
history of vasovagal responses will be supine during venipuncture. 
15) Risk of worsening of pain symptoms
It is possible that the subject may have a worsening of pain symptoms or that they
may not obtain any therapeutic benefit from the treatment. The risk of worsening
pain symptoms is uncommon. In addition, subjects will have the opportunity to
discontinue treatment if their stimulation is too uncomfortable. 
These risks are mitigated by clinical training on the safe limits. Subjects do not have
access to make changes to the programming controls and thus could not advertently
change the value. 
16) Risks of Outcomes Assessments
The questionnaires and Fugl-Meyer Assessment present no risks. The assessments
of shoulder torque and kinematics may be slightly uncomfortable. The measures of
central sensitization (mechanical pain thresholds for hyperalgesia, pinprick pain
thresholds for hyperalgesia, temporal summation of repetitive pin-prick stimuli) may
be slightly uncomfortable and may cause brief skin irritation. The optional measures
(tactile/touch, vibration and thermal/thermal pain detection thresholds, temporal
summation of repetitive thermal stimuli, and Conditioned Pain Modulation (CPM))
also may be uncomfortable and may cause brief skin irritation. 
17) Other
Some of the survey questions present a rare risk of psychological harm. 
When PHI is involved there is the rare risk of a privacy breach. 
There may be other risks as yet unknown. 
21.25
Please list all precautions, warnings, and contraindications: 
Detailed precautions, warnings, and contraindications are detailed in the manuals
attached at 27.1. 
List all precautions, warnings
and contraindications.
View: 21-03 Medical Device IV
21.03 Medical Device IV
INVESTIGATOR’S RESPONSIBILITY FOR CONTROL OF THE INVESTIGATIONAL DEVICES:
To protect the rights, safety and welfare of research participants the investigator must ensure control and
accountability of all devices used in conjunction with clinical research protocols. To make certain that investigational
devices are used only on research participant’s who have signed the informed consent form specific for the device
and IDE number. 
21.26 
  The device will not be used on a research participant until FDA(when FDA
regulated investigational device is being studied) and IRB approval has been
obtained and the research participant has signed an informed consent document.
Please check these boxes
21.27
  The informed consent document will inform the research participants that their
names and information will be shared with the device company for tracking
purposes.
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Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
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21.28 
  The investigation will be conducted in accordance with the signed agreement
with the sponsor, the investigational plan, and all applicable laws and regulations.
 
 
21.29
 The device will be used only in accordance with the MHS IRB approved protocol.
21.30
  The Investigator is thoroughly familiar with the appropriate use of the
investigational device, as described in the protocol, in the product information, and
in other information sources provided by the sponsor.
21.31
  All persons assisting with the trial are adequately informed about the protocol
and the investigational product(s).
21.32
 Devices will be properly maintained and cleaned.
21.33
  Research participants will receive adequate instructions about the
investigational device to assure their safe participation in a research study.
21.34
Any investigational devices used in conjunction with an investigational protocol must be kept in a locked
and secured area. Access to investigational devices must be limited to personnel designated by the
Principal Investigator. Please describe How you will secure the investigational devices to be used in this
study and who will have access to them.
Device accountability will be maintained by the Investigator and his study staff. All devices that are not deployed will
be secured by the research staff in their offices and/or labs. Dr. Wilson and Peggy Maloney will have primary
responsibility for device accountability, but the other staff listed in this protocol will share responsibility. 
21.35 
Attach copies of device logs, see examples of logs on the IRB Home Page in the IRB Guidelines Section
under MHS Medical Device Guidelines : 
Name
Version
PNS Dose for HSP Device Inventory Log (13-Dec-2017) | History
0.04
View: 22-00 Clinical Trials Registration
22.0   Clinical Trials Registration:
Note: Phase 2 - 4 trials of drugs and biologics (controlled clinical investigations other than Phase 1 investigations of a product
subject to FDA regulation) AND trials of devices (controlled trials with health outcomes, other than small feasibility
studies and pediatric post-marketing surveillance) must be registered per the Food and Drug Administration Act of
2007;  NIH encourages registration of all trials, regardless of whether required under applicable law.
How are study protocols submitted to ClinicalTrials.gov? 
The FDA Guidance Document (March 2002) (http://www.fda.gov/cder/guidance/4856fnl.htm) describes the submission criteria.
The NLM has developed the Protocol Registration System (PRS), a Web-based tool for submitting information to ClinicalTrials.gov.
Study sponsors or their representatives may register online to apply for a PRS account (http://prsinfo.clinicaltrials.gov/).
22.1 
Has this trial been registered on www.clinicaltrials.gov? 
Yes 
No
Web link to clinical trails
website. 
22.2
If Yes, who registered the trial?(i.e. sponsor, investigator) 
Investigator 
Please respond 
22.3 
Please provide ClinicalTrials.gov Identifier (i.e. NCT00391872)
NCT02928055
The sponsor can provide you
with this information or you can
look it up on the website.
22.4
If No, are there plans to register the study? 
Yes 
No
If you answer No you must
provide an reason why this
study will not be registered.
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22.5
If the answer to 22.4 is No, provide and explanation: 
Provide a response if the
answer to 22.4 is No.
View: 23-00 Interview/Focus Groups
23.0 Interview/Focus Groups:
23.1 
Does this study involve Interviews/Focus Groups? No
If you answer no and hit continue you will go to the next page.
Answer yes or no.
23.2
Attach copies of any scripts/or questions that will be used to guide the
interview focus/groups: 
Name
Version
There are no items to display
Attach scripts or questions.
23.3
Idendtify all Staff conducting interviews on page 1 question 1.4 by selecting
the correct role.
23.4 
Is there any specific training or qualifications needed to conduct the
interviews/focus groups? 
Describe training and/or
qualifications. 
View: 24-00 Psychological Testing
24.0 Psychological Testing:
24.1 
Does this study involve Psychological testing? Yes   
If you answer no and hit continue you will go to the next page. 
Answer yes or no.
24.2 
First Please list all Psychological Tests that will be given: 
Mini Mental State Exam (MMSE)
First please list the
test(s)/measures to be used. 
24.3
Attach copies of all psychological test(s)/measures that will be used for
this study: 
Name
Version
MMSE | History
0.02
Second attach copies of all
test(s)/measures.
24.4
Is there any necessary training or licenses required of those administering
the psychological testing? 
No for MMSE. 
Idendtify all Staff Administering tests on page 1 question 1.4 by selecting
the correct role.
Describe any training or licenses
required to administer test(s).
View: 25-00 Surveys/Questionnaires
25.0 Surveys/Questionnaires:
25.1 
Does this study involve Surveys/Questionnaires? Yes
If you answer no and hit continue you will go to the next section.  
Answer yes or no.
25.2
Please attach all questionnaires and/or surveys to be used in this study: 
Name
Version
BDI-2 | History
0.02
BPI-SF Last Week | History
0.02
Attach
survey(s)/questionnaire(s).
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
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Name
Version
FABQ | History
0.01
PCS- Pain Catastrophizing Scale | History
0.01
PGIC (Shoulder Studies, Feb-2017) | History
0.01
SF-36 | History
0.02
25.3
Idendtify all Staff conducting Surveys on page 1 question 1.4 by selecting
the correct role.
View: 26-00 Deception
26.0  Deception:
Deception is a research methodology. When deception is used in research the subject is not told, or is
misled, about the true purpose of the research, such as in certain studies of group processes, contextual
influences on cognition, etc.
 26.1 
Does this study involve the use of deception as a study design method for
the research? 
No  
If you checked no then hit the continue button and you will be taken to the next
page.
Deception is defined as
intentionally misleading or
withholding information about
the nature of the experiment. 
26.2
Describe in detail the nature of the deception and explain why this is
necessary for the research: 
Please describe the nature of
the deception. 
26.3 
State how, when and by whom the research subjects will be debriefed: 
Briefly describe your plan to
debrief subjects. 
View: 27-00 Additional Documents
27.0 Additional Documents:
27.1 
Are there any additional study documents you wish to attach to this
application?   
Name
Version
Bandage change Instruction and stimulator instructions.docx | History
0.01
Electrode Fragment Information Sheet 4.0 | History
0.02
Electrode Fragment Wallet Card 2.0 | History
0.02
Instructions for Care of Electrode Exit Site 1st 48 hrs | History
0.02
Instructions for Care of Electrode Exit Site 1st 48 hrs(with Mark
up).docx | History
0.01
Instructions for Care of Electrode Exit Site 2.0 | History
0.03
Instructions for Care of Electrode Exit Site 2.0(with mark
up).docx | History
0.01
PNS Dose for HSP Other Therapy Diary | History
0.01
PNS Dose for HSP Phone Log | History
0.01
PNS Dose for HSP Screening Form | History
0.01
Quick Start Guide for Start of Stimulation | History
0.01
Sprint Clinician Manual (L0044-MAN-000-J) | History
0.02
Sprint Patient Manual (L0045-MAN-000-I) | History
0.02
Attach any additional study
documents i.e protocols supplied
by sponsor.
View: The End
To Finalize this application you must do two things:
1.) As a final step you should click on Hide/Show Errors on the top of this page. If there are any required fields in the Application you
have omitted they will show up in red. If you click on each item you will be taken to that page of the application so you can complete
the question.
Note: Unless all named Co-investigators have agreed to participate you will not be able to submit your study. Co-Investigators have to
press the Co-Investigators agree to participate button. You can send them an email message tellng them to do this by pressing
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Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
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Notify Co-Investigators of Need to Agree to Participate. The minute you have selected your Co-Investigators you can press this button
it is not advisable to wait until you have completed the application as it may hold up your submission.
When all error messages are gone then... 
2.) Click Finish
Please click on the "Finish" button to finalize and exit the Study application.  Doing so will NOT submit the application for review.  
3.) The PI must press the Submit Study button (when they are ready to submit to the IRB)
Please note that a submission may only be forwarded to the IRB by the Principal Investigator.  To do this, the Principal Investigator
must push " Submit Study" in the blue area on the left hand side of the page under My Activities. Only the PI will have this button
it will not be visible to any other study team members. 
You can track the ongoing status of your submission by logging into the study workspace. On the top left hand side of the page in the
light blue area there will be a box labeled with the Current State of your study. 
Please contact the IRB with any questions or concerns. When calling the IRB Office Please direct your questions to the IRB staff named
as the "Owner" of your study. 
View: CCF Key Personnel Questions View
* Name of Key Personnel Working on Study:  Terri Hisel
Study Role: 
Name
Research Support Staff
Interviewer (Survey, Focus Group)
Psychological Testers
View: CCF Key Personnel Questions View
* Name of Key Personnel Working on Study:  Nathaniel Makowski
Study Role: 
Name
Research Support Staff
View: CCF Key Personnel Questions View
* Name of Key Personnel Working on Study:  Robert Wissner
Study Role: 
Name
Co-investigator
View: CCF Key Personnel Questions View
* Name of Key Personnel Working on Study:  Kristine Hansen
Study Role: 
Name
Study Coordinator
Research Support Staff
DRA (only one)
Interviewer (Survey, Focus Group)
Psychological Testers
Obtaining Informed Consent
eIRB Notification Recipient
View: CCF Key Personnel Questions View
* Name of Key Personnel Working on Study:  John Chae
Study Role: 
Name
Co-investigator
View: CCF Key Personnel Questions View
* Name of Key Personnel Working on Study:  Richard Wilson
Study Role: 
Name
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
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Name
Co-investigator
Psychological Testers
Obtaining Informed Consent
View: CCF Key Personnel Questions View
* Name of Key Personnel Working on Study:  Amy Friedl
Study Role: 
Name
Research Support Staff
Interviewer (Survey, Focus Group)
Psychological Testers
Obtaining Informed Consent
View: CCF Key Personnel Questions View
* Name of Key Personnel Working on Study:  Shannon Hogan
Study Role: 
Name
Research Support Staff
View: CCF Key Personnel Questions View
* Name of Key Personnel Working on Study:  Victoria Whitehair
Study Role: 
Name
Research Support Staff
View: CRU DSMP Data Collection Simple View
Name: Chart Review, interview, questionnaire 
Level of Risk: Minimal and Low Risk Studies 
Type: Data Collection
View: CRU DSMP Data Collection Simple View
Name: Elderly Population 
Level of Risk: Moderate Risk Studies 
Type: Study Population
View: CRU DSMP Data Collection Simple View
Name: Psychologically or neurologically impaired population 
Level of Risk: Moderate Risk Studies 
Type: Study Population
View: Create CRU Procedure Risk
CRU Procedure Risk:
 Procedure
Risk
* Outcomes Assessments (questionnaires, tests of arm and
shoulder movement, pain thresholds)
* 
Name
Minimal or Low
Moderate
High
View: Create CRU Procedure Risk
CRU Procedure Risk:
 Procedure
Risk
* Percutaneous electrode implant procedure/short term
implant and e-stim
* 
Name
Minimal or Low
Moderate
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Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
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Name
High
View: Create CRU Procedure Risk
CRU Procedure Risk:
 Procedure
Risk
* Percutaneous electrode removal
* 
Name
Minimal or Low
Moderate
High
View: Create CRU Procedure Risk
CRU Procedure Risk:
 Procedure
Risk
* Venipuncture
* 
Name
Minimal or Low
Moderate
High
View: Create CRU Procedure Risk
CRU Procedure Risk:
 Procedure
Risk
* X-Ray
* 
Name
Minimal or Low
Moderate
High
ID: IRB16-00510
Peripheral Nerve Stimulation for Shoulder Pain: Dose Response. Document Date: 12/18/2020
NCT02928055