A Post-Market, Observational Clinical Study to Evaluate the Effects of Differential Target Multiplexed DTM™ SCS Programming in Treating Intractable Chronic Upper Extremity Limb Pain
Conditions: Upper Limb, Pain
Sponsor: SGX Procura LLC

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CLINICAL STUDY PLAN 
 
A Post-Market, Observational Clinical Study to Evaluate the Effects of DTMTM SCS 
programming in treating Intractable Chronic Upper Extremity Limb Pain 
 
Protocol Number:  
 
DTM-PROC-2020PM3 
 
NCT Number:  
 
04466111 
 
Protocol Reference:  
DTM SCS ULP 
 
Sponsor:  
 
 
SGX PROCURA, LLC     
2406 East Empire Street 
Bloomington, IL 61704 
 
Study Responsibility:  
Wesley Park 
 
 
 
 
Vice President, Clinical Affairs 
 
 
 
 
SGX PROCURA 
 
Date of Issue:  
 
30JUL2021 
 
Revision: 
 
 
3.0 
 
Revision History: 
 
 
 
 
 
 
Revision 
Description 
Date 
1.0 
Initial Release of Clinical Study Plan 
20APR2020 
2.0 
Amendment of the Clinical Study Plan 
Addition of 6-month visit 
02FEB2021 
3.0 
Amendment of the Clinical Study Plan 
Addition of 12-month visit 
30JUL2021 

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PROTOCOL SYNOPSIS 
 
Study Title 
A Post-Market, Observational Clinical Study to Evaluate the Effects of DTMTM 
SCS programming in treating Intractable Chronic Upper Limb Pain 
Protocol 
Number 
DTM-PROC-2020PM3 
Study 
Device 
IntellisTM neurostimulator, a Spinal Cord Stimulation (SCS) device system 
manufactured and commercialized by Medtronic (Minneapolis, MN) 
 
Study 
Purpose 
The purpose of this observational clinical study is to evaluate the effectiveness 
and to collect safety data of DTMTM SCS programming on subjects with 
chronic, unilateral or bilateral upper limb pain. 
 
Study 
Design 
This is a post-market, open-label, prospective, multi-center, observational 
study evaluating upper limb pain relief with the DTM SCS programming 
approach. 
Data at follow-up visits will be compared to baseline assessments collected at 
the beginning of the study. 
 
Study Size 
Up to 90 subjects may be consented and screened in clinical sites in the United 
States.   
This would allow approximately 45 subjects to be implanted. 
 
Study 
Duration 
The expected total duration of this study is approximately 26months. 
Enrollment of subjects is expected to last 20 months. Subjects that have 
received the permanent implant will be followed up for 12 months after their 
device has been activated. A subject will likely be committed to the study for 
about 14 months. This consists of Baseline assessments, up to 10 days of trial 
stimulation and 12months of treatment following implantation and activation 
of the device. All current subjects or those who have completed their 6-month 
visit will be offered to return for an additional 12-month visit.  This would 
increase their commitment to the study to 14 months. 
Study 
Objective 
The primary objective of this study is to evaluate the effectiveness of DTM SCS 
programming as a treatment for reducing intractable chronic pain of the upper 
limbs. 

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The secondary objectives of this study are to further characterize the 
effectiveness of DTM SCS programming for the treatment of chronic pain of the 
upper limb and to collect safety data of DTM SCS programming. 
Inclusion 
Criteria 
A subject must MEET ALL of the following inclusion criteria: 
1. Be diagnosed with chronic, intractable pain of the upper limb related to 
the cervical spine and/or neuropathic arm pain. 
2. Be a candidate for SCS system (trial and implant) per labeled indication 
(upper limb pain due to one of the conditions listed in indications 
statement) 
3. Considering daily activity and rest, has average upper limb pain intensity of 
≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment  
4. Be willing and capable of giving written informed consent to participate in 
this clinical study based on voluntary agreement after a thorough 
explanation of the subject's participation has been provided. 
5. Be willing and capable of subjective evaluation, read and understand 
written questionnaires, and read, understand and sign the written inform 
consent. 
6. Be 18 years of age or older at the time of enrollment 
7. Be on a stable pain medication regime, as determined by the study 
Investigator, for at least 30 days prior to enrolling in this study 
8. Be willing and able to comply with study-related requirements, 
procedures, and visits, including not increasing pain medications through 
the three month visit 
9. Has adequate cognitive ability to use a patient programmer and recharger 
as determined by the Investigator  
Exclusion 
Criteria 
A subject must NOT MEET ANY of the following exclusion criteria: 
1. Has a medical, anatomical, and/or psychosocial condition that is 
contraindicated for commercially available IntellisTM SCS systems as 
determined by the Investigator 
2. Have a medical condition or pain in other area(s), not intended to be 
treated with SCS, that could interfere with study procedures, as 
determined by the Investigator 
3. Currently enrolled or planning to enroll in an interventional clinical study 
that could potentially confound the study results (co-enrollment in an 
interventional study is only allowed when documented pre-approval is 
obtained from the study manager or designee) 
4. Has an existing active implanted device such as a pacemaker, another SCS 
unit, peripheral nerve stimulator, and/or drug delivery pump. 
5. Has pain in other area(s) and/or medical condition requiring the regular 
use of significant pain medications that could interfere with accurate pain 

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reporting, study procedures, and/or confound evaluation of study 
endpoints, as determined by the Investigator 
6. Has significant cervical stenosis, as determined by the Investigator 
7. Has facet spondylosis, as determined by the Investigator 
8. Has mechanical spine instability, as determined by the Investigator 
9. Has undergone, within 30 days prior to enrollment, an interventional 
procedure and/or surgery to treat upper limb pain, which is providing 
significant pain relief  
10. Has unresolved major issues of secondary gain (e.g., social, financial, legal, 
such as worker compensation matters)  
11. Be pregnant as determined by urine testing unless female subject is 
surgically sterile or post-menopausal. If female, sexually active, and 
childbearing age, subject must be willing to use a reliable form of birth 
control. 
12. Have evidence of an active disruptive psychological or psychiatric disorder 
as determined by a psychologist 
13. Have a current diagnosis of a progressive neurological disease as 
determined by the Investigator 
14. Have a current diagnosis of a coagulation disorder, bleeding diathesis, 
progressive peripheral vascular disease or uncontrolled diabetes mellitus 
15. Have a condition that the Investigator determines would significantly 
increase perioperative risk 
16. Any previous history of surgery on the posterior elements (laminectomy, 
posterior fusion) of the cervical spine 
17.  Have metastatic malignant disease or active local malignant disease 
18. Have a life expectancy of less than 1 year 
19. Have an active systemic or local infection 
20. Have within 6 months of enrollment a significant untreated addiction to 
dependency producing medications or have been a substance abuser 
(including alcohol and illicit drugs)  
Primary 
Endpoint 
The primary efficacy endpoint is the percentage of implanted subjects who 
respond to DTM SCS therapy at 3-months after device activation. An individual 
responder is a subject that experiences at least a 50% decrease in upper limb 
pain relative to baseline assessment.   
 

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TABLE OF CONTENTS 
 
 
 
 
 
 
 
 
 
PAGE 
Contents 
Protocol SYNOPSIS ...........................................................................................................................2 
Table of Contents .............................................................................................................................6 
A. Purpose ......................................................................................................................................9 
A.1. Study Device .................................................................................................................9 
A.2. Purpose of the Investigation .......................................................................................9 
A.3. Study Size .....................................................................................................................9 
A.4. Duration of the Investigation.................................................................................... 10 
B.1. Rationale for Study ................................................................................................... 10 
B.2. Study Objectives ....................................................................................................... 11 
B.3. Selection of Study Population ................................................................................. 11 
B.3.1. Study Population ........................................................................................ 12 
B.3.2. Inclusion Criteria ........................................................................................ 12 
B.3.3. Exclusion Criteria ....................................................................................... 12 
B.4. Treatment Groups ..................................................................................................... 14 
B.5. Study Design.............................................................................................................. 14 
B.5.1. Overall Design ............................................................................................ 14 
B.5.2. Bias Minimization ....................................................................................... 14 
B.5.3. blinding ........................................................................................................ 14 
B.5.4. Sample Size................................................................................................ 14 
B.5.4.1 Sample size rationale.............................................................................. 15 
B.5.5. Study Duration............................................................................................ 15 
B.6. Enrollment, Assessments, and Clinical Procedure .................................. 15 
B.6.1. Summary of Study Protocol ..................................................................... 15 
B.6.2. PRE-SCREENING/CONSENT/ENROLLMENT.................................... 16 
B.6.3. ELIGIBILITY Criteria Evaluation .............................................................. 17 
B.6.4. Baseline ....................................................................................................... 19 
B.6.5. SCS Trial Phase ........................................................................................ 19 
B.6.6. End of Trial Assessment ........................................................................... 20 
B.6.7. Permanent Device Implant (0-60 days from end of successful Trial 
Phase) ......................................................................................................... 20 
B.6.8. Device Activation (0-14 days following Permanent Implant) .............. 20 
B.6.9. Unscheduled Visits .................................................................................... 21 
B.6.10. Telephone Calls ....................................................................................... 21 

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B.6.11. 1 Month After Device Activation (± 15 days) ....................................... 21 
B.6.12. 3 Months After Device Activation (± 21 days) ..................................... 21 
B.6.13. 6 Months After Device Activation (± 31 days) ..................................... 21 
B.6.14. 12 Months After Device Activation (± 31 days) ................................... 22 
B.6.15 Other Assessments and Information ..................................................... 22 
B.6.16. Device Explant ......................................................................................... 24 
B.6.17. Early Subject Withdrawal ....................................................................... 24 
B.6.18. Study Completion .................................................................................... 24 
B.6.19. Study Suspension and Termination ..................................................... 25 
B.7. Study Endpoints ........................................................................................................ 26 
B.7.1. Definition of Analysis Populations ........................................................... 26 
B.7.2. Effectiveness Assessment Definitions.................................................... 26 
B.7.3. Primary Endpoint ....................................................................................... 26 
B.7.4. Secondary Endpoints ................................................................................ 26 
B.7.5. Additional Data Collection ........................................................................ 27 
B.8. Evaluation Criteria ..................................................................................................... 27 
B.8.1. Effectiveness .............................................................................................. 27 
B.8.3. Safety ........................................................................................................... 28 
B.8.3.1 Definitions ................................................................................................. 28 
B.8.3.2 Reporting .................................................................................................. 29 
B.9. Data Collection and Analysis .................................................................................. 29 
B.9.1. Data Collection ........................................................................................... 29 
B.9.2. Statistical Analysis ..................................................................................... 29 
C.  Risk Analysis......................................................................................................................... 31 
C.1. Description and Analysis of All Increased Risks to Subjects ............................. 31 
C2.  Minimization of Risks................................................................................................ 33 
C3.  POTENTIAL bENEFITS ........................................................................................... 34 
D.  Description of the Device .................................................................................................... 34 
D.1. Each Important Component, Ingredient, and Property of the Device............... 34 
D.1.1. Device System Overview ......................................................................... 34 
D.1.2. Device System Details .............................................................................. 35 
D.1.2.1 Major Components .................................................................................. 36 
D.1.2.2. Surgical Accessories ............................................................................. 37 
D.2. Principle of Operation of the Device ...................................................................... 38 
D.3. Labeling ...................................................................................................................... 38 
D.4. Any Anticipated Changes in the Device ................................................................ 38 
E.  Administrative Procedures .................................................................................................. 38 
E.1. Monitoring ................................................................................................................... 38 

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E.1.1. Study Clinical Monitor ............................................................................... 39 
E.1.2. Monitoring Procedures .............................................................................. 39 
E.2. Data Quality Assurance ........................................................................................... 40 
E.3. Study Conduct ........................................................................................................... 40 
E.4. Informed Consent Materials .................................................................................... 41 
E.5 Investigators and Institutions .................................................................................... 41 
E.6. Amendments and Deviations .................................................................................. 41 
E.7. Additional Record and Reports ............................................................................... 42 
9. 
References ...................................................................................................................... 43 
 
 
 

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A. PURPOSE 
A.1. STUDY DEVICE 
The IntellisTM neurostimulator is a commercially available implantable component of a Spinal 
Cord Stimulation (SCS) device system manufactured by Medtronic (Minneapolis, MN). The 
system is indicated for spinal cord stimulation (SCS) as an aid in the management of chronic 
intractable pain of the trunk and/or limbs. It is designed to deliver electrical stimulation to 
the spinal cord using arrays of electrodes (also called leads) placed in the dorsal epidural 
space. The study will use the commercially available IntellisTM neurostimulator and 
compatible SCS system components from Medtronic using stimulation parameters within the 
specifications approved for use in the approved indications. The study will stimulate the 
cervical dorsal columns of the spinal cord. Section D of this Clinical Study Plan provides 
detailed description of IntellisTM neurostimulator. 
 
A.2. PURPOSE OF THE INVESTIGATION 
The purpose of this post-market, observation study is to characterize the effectiveness and 
collect safety data of DTM SCS programming on subjects with chronic, intractable unilateral 
or bilateral pain of the upper limbs. This study is an observational, open-label, multi-center, 
prospective evaluation of treatment outcomes resulting from the DTM SCS programming 
approach relative to pretreatment measurements. The DTM SCS programming approach will 
be discussed in section B.1 of this Clinical Study Plan. 
 
This investigation will utilize a commercially available SCS system (IntellisTM neurostimulator 
and compatible SCS components) as is, without any modification, and using FDA-approved 
parameters. Outcomes will be assessed via standardized tests.  
 
A.3. STUDY SIZE 
Approximately 45 subjects are expected to complete the 3-month endpoint of the study. Up 
to 90 subjects may be consented to participate at clinical sites in the United States. A sample 
size estimate is discussed further in section B.5.5 of this Clinical Study Plan.  
 

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A.4. DURATION OF THE INVESTIGATION 
The expected total duration of this study is approximately 26 months.  Enrollment of subjects is 
expected to last 20 months. Subjects that have received the permanent implant will be 
followed up for 12 months after their device has been activated. A subject will likely be 
committed to the study for about 14 months. This consists of Baseline assessments, up to 10 
days of trial stimulation, and 12 months of treatment following implantation and activation of 
the device. All current subjects or those who have completed their 6-month visit will be offered 
to return for an additional 12-month visit.  This would increase their commitment to the study 
to 14 months. 
B.1. RATIONALE FOR STUDY 
It is estimated that about 20% percent of the population worldwide is affected by moderate 
to severe chronic pain1. Chronic pain becomes a burden to the individual as this affects a 
person’s ability to carry out many daily life activities, such as exercising, walking, driving a car, 
attending social events, or performing household chores.  In the United States, chronic pain 
is considered one of the most pervasive and intractable conditions affecting at least one third 
of the population at an estimated cost of five hundred billion dollars per year, when 
combining health-related expenditure and the cost-impact on loss of productivity and 
income2. Low back pain, neck pain and limb pain are among the most prevalent pain 
conditions worldwide, all of them ranked in the top 10 for the most disabling conditions.3   
Conventional medical management, including medication and physical therapy, is often not 
adequate for treating chronic pain. Medication therapy based on opioids may also lead to 
addiction. Extensive use of opioid medications in the United States has led to the declaration 
of an epidemic crisis4. Furthermore, surgical interventions have also failed to remediate 
severe cases of neuropathies and intractable pain for many patients. Spinal cord stimulation 
(SCS) is a proven therapy that has been in use for about 50 years for various types of chronic 
pain. It is currently indicated for the treatment of intractable chronic pain of the trunk and/or 
limbs. SCS is a reversible therapy that allows patients to evaluate the therapy for several days 
using an external neurostimulator (ENS) prior to receiving an implantable neurostimulator 
(INS) system5,6,7,8. Spinal Cord Stimulation (SCS) utilizes pulsed electric fields that are applied 
to the dorsal section of the spinal cord via electrode arrays, called leads, implanted in the 
epidural space.   
The conventional programming approach in SCS utilizes pulsed electric fields oscillating in the 
40-250 Hz frequency range. The electric field induces a stimulation pattern (paresthesia), 
which is steered by the clinician and patient to overlay with the targeted pain location by 
modifying the duration (pulse width) and intensity of the applied electric field. The concept 
behind this programming approach is that the stimulation pattern induced by the electric 
field masks pain signals travelling to the brain. Although proven effective for the treatment 
of intractable chronic pain of the upper limbs by some practitioners, the variability of the 
paresthesia sensation, including uncomfortable sensations, due to the motion of the neck 

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have limited the utilization of the conventional SCS programming approach.  
The DTM SCS programming approach relies on stimulation parameters that can be set by the 
clinician and patient to levels that avoid uncomfortable stimulation upon motion of the neck, 
while providing pain relief on the affected limb(s).  DTM SCS programming will use stimulation 
parameters that are currently available in the device to be used in this study.  
In a given therapy group, DTM SCS will provide programs with different pulse rates, pulse 
widths and intensities for the goal of better pain relief.  For example, starting parameters may 
be a combination of a program with 50 Hz pulses with a duration of up to 200 microseconds 
and a program with 300 Hz pulsed with a pulse duration of up to 200 microseconds, while 
intensities will be custom adjusted by the patient for optimal pain relief and therapy comfort.  
It is anticipated that the low pulse amplitudes used in the DTM SCS programming approach 
would result in patients experiencing less uncomfortable stimulation events with the motion 
of the neck and upper limbs than what they might experience with a conventional SCS 
programming approach while providing effective pain relief. Should DTM SCS programming 
be shown to be effective and safe in this observational study, DTM SCS may offer an 
alternative approach that will help thousands of chronic pain sufferers make substantial 
improvement in pain relief, reduction in disabilities, and reduce the likelihood of 
uncomfortable paresthesia. 
The study design is a post-market, open-label, prospective, observational multi-center study 
that will evaluate DTM SCS for chronic upper limb pain sufferers. Subjects participating in the   
study will trial SCS according to standard practice. Those who experience a successful trial 
will be eligible to get a permanently implanted device and evaluate the primary effectiveness 
point.  
 
B.2. STUDY OBJECTIVES 
The primary objective of this study is to characterize the application of DTM SCS 
programming as a treatment for reducing intractable chronic pain of the upper limbs. 
The secondary objectives of this study are to further characterize the effectiveness of DTM 
SCS programming for the treatment of chronic pain of the upper limbs and to collect safety 
data of DTM SCS programming.  
 
B.3. SELECTION OF STUDY POPULATION 
 

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B.3.1. STUDY POPULATION  
The intended study population is individuals who have been diagnosed with chronic, 
intractable pain of the upper limbs associated with a number of conditions, and who the 
Principal Investigator deems is an appropriate candidate for SCS therapy as required for 
this study in this Clinical Study Plan.  
B.3.2. INCLUSION CRITERIA 
In order to participate in the study, a subject must MEET ALL of the following inclusion 
criteria: 
1. Be diagnosed with chronic, intractable pain of the upper limbs related to the 
cervical spine and/or neuropathic arm pain. 
2. Be a candidate for SCS system (trial and implant) per labeled indication (upper 
limb pain due to one of the conditions listed in indications statement) 
3. Considering daily activity and rest, has average upper limb pain intensity of ≥ 5 
out of 10 cm on the Visual Analog Scale (VAS) at enrollment  
4. Be willing and capable of giving written informed consent to participate in this 
clinical study based on voluntary agreement after a thorough explanation of the 
subject's participation has been provided. 
5. Be willing and capable of subjective evaluation, read and understand written 
questionnaires, and read, understand and sign the written inform consent. 
6. Be 18 years of age or older at the time of enrollment 
7. Be on a stable pain medication regime, as determined by the study Investigator, 
for at least 30 days prior to enrolling in this study 
8. Be willing and able to comply with study-related requirements, procedures, and 
visits, including not increasing pain medications through the three months visit 
9. Has adequate cognitive ability to use a patient programmer and recharger as 
determined by the Investigator  
B.3.3. EXCLUSION CRITERIA 
In order to participate in the study, a subject must NOT MEET ANY of the following exclusion 
criteria: 
1. Has a medical, anatomical, and/or psychosocial condition that is contraindicated 
for commercially available IntellisTM SCS systems as determined by the 
Investigator 
2. Have a medical condition or pain in other area(s), not intended to be treated 
with SCS, that could interfere with study procedures, as determined by the 
Investigator 
3. Currently enrolled or planning to enroll in an interventional clinical study that 
could potentially confound the study results (co-enrollment in an interventional 

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study is only allowed when documented pre-approval is obtained from the study 
manager or designee) 
4. Has an existing active implanted device such as a pacemaker, another SCS unit, 
peripheral nerve stimulator, and/or drug delivery pump. 
5. Has pain in other area(s) and/or medical condition requiring the regular use of 
significant pain medications that could interfere with accurate pain reporting, 
study procedures, and/or confound evaluation of study endpoints, as 
determined by the Investigator 
6. Has significant cervical stenosis, as determined by the Investigator 
7. Has facet spondylosis, as determined by the Investigator 
8. Has mechanical spine instability, as determined by the Investigator 
9. Has undergone, within 30 days prior to enrollment, an interventional procedure 
and/or surgery to treat upper limb pain, which is providing significant pain relief  
10. Has unresolved major issues of secondary gain (e.g., social, financial, legal, such 
as worker compensation matters)  
11. Be pregnant as determined by urine testing unless female subject is surgically 
sterile or post-menopausal. If female, sexually active, and childbearing age, 
subject must be willing to use a reliable form of birth control. 
12. Have evidence of an active disruptive psychological or psychiatric disorder as 
determined by a psychologist 
13. Have a current diagnosis of a progressive neurological disease as determined by 
the Investigator 
14. Have a current diagnosis of a coagulation disorder, bleeding diathesis, 
progressive peripheral vascular disease or uncontrolled diabetes mellitus 
15. Have a condition that the Investigator determines would significantly increase 
perioperative risk 
16. Any previous history of surgery on the posterior elements (laminectomy, 
posterior fusion) of the cervical spine 
17.  Have metastatic malignant disease or active local malignant disease 
18. Have a life expectancy of less than 1 year 
19. Have an active systemic or local infection 
20. Have within 6 months of enrollment a significant untreated addiction to 
dependency producing medications or have been a substance abuser (including 
alcohol and illicit drugs) 
 
 

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B.4. TREATMENT GROUPS 
Subjects meeting the study eligibility criteria will be treated with DTM SCS programming 
approach. A trial period of up to ten days, which is the standard of care in SCS, will serve to 
determine if a subject is eligible to undergo permanent implantation of the SCS system. 
B.5. STUDY DESIGN 
B.5.1. OVERALL DESIGN 
This is a post-market, prospective, open-label, observational, multi-center study designed 
to evaluate the effectiveness and to collect safety data of the DTM SCS programming 
approach in subjects with chronic, intractable pain of the upper limbs. Data at follow-up 
visits will be compared to baseline data collected at the beginning of the study. 
B.5.2. BIAS MINIMIZATION 
This Clinical Study Plan and its associated documentation have been designed to minimize 
potential sources of bias.  Each Investigator’s qualification for meeting the requirements of 
this Clinical Study plan will be reviewed prior to their participation in this investigation.   
B.5.3. BLINDING 
This open label, single-arm study is not blinded. All subjects eligible to participate will be 
trialed with commercially available Intellis trialing SCS system. Those who successfully trial 
DTM SCS programming may be implanted with a commercially available Intellis SCS system. 
B.5.4. SAMPLE SIZE 
Primary Endpoint Assessment occurs at the 3-months follow up visit after activation of the 
implanted device. There is no statistical hypothesis to be evaluated in this study, but it is 
believed that approximately 45 subjects will be required to evaluate the effectiveness and 
to collect additional safety data of DTM SCS programming at the primary endpoint. Based 
on this requirement, the estimated sample size of this study is up to 90 consented subjects.,  

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B.5.4.1 SAMPLE SIZE RATIONALE 
There is no statistical hypothesis to be evaluated in this study. It is believed that 
approximately 45 subjects permanently implanted subjects will be sufficient to evaluate 
the effectiveness and to collect additional safety data of the DTM SCS programming in the 
target population at the primary endpoint. 
Up to 90 subjects will be consented to participate in the eligibility screening process. 
Those who do not meet all the inclusion criteria and none of the exclusion criteria will be 
considered screen failures and will not move into the trialing phase. It is estimated that 
approximately 55 subjects will be trialed. Only subjects with a successful trial phase will 
be eligible to move into permanent implantation of the device.   
B.5.5. STUDY DURATION 
The expected total duration of this study is approximately 26 months. Enrollment of 
subjects is expected to last 20 months. Subjects that have received the permanent implant 
will be followed up for 12 months after their device has been activated. A subject will likely 
be committed to the study for about 14 months. This consists of Baseline assessments, up 
to 10 days of trial stimulation, and 12 months of treatment following implantation and 
activation of the device. All current subjects or those who have completed their 6-month 
visit will be offered to return for an additional 12-month visit.  This would increase their 
commitment to the study to 14 months 
 
 
B.6. ENROLLMENT, ASSESSMENTS, AND CLINICAL PROCEDURE 
Enrollment of subjects will occur at the clinical sites after Institutional Review Board (IRB) 
approvals, and when written informed consent from subjects has been obtained.  Prior to 
enrollment, Investigators and clinical site staff will approach subjects, who have been 
determined to be candidates for SCS therapy and talk about potential participation in the 
study.  Following informed consent, the eligibility of subjects to participate in the study will 
be assessed according to inclusion and exclusion criteria outlined in this Clinical Study Plan.  
Various assessments including pain intensity, evaluation of medical history and records, and 
the Investigator’s clinical judgment will be used in the selection process.  
B.6.1. SUMMARY OF STUDY PROTOCOL 
Potential study subjects will be identified from a pool of candidates for SCS therapy that 
are either affiliated with or referred to the clinical sites.  Advertisements of the study may 
be used for recruitment purposes, upon approval of the patient recruitment materials by 
the study IRB(s). An informed consent form (ICF) will be given to the potential subject for 
private evaluation. The Investigator or Study Clinical Staff will be available to respond to 

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any questions the potential subject may have during evaluation of the ICF. Potential study 
subjects willing to participate in the study will visit the study site for providing written 
consent and for evaluation of eligibility to participate based on inclusion and exclusion 
criteria.  Once a consented subject is deemed qualified to participate in the study, baseline 
assessments will occur followed by scheduling of the trial stimulation phase.  
Subjects who complete a successful DTM SCS trial phase will be scheduled to receive a 
permanent implant of the SCS system and will undergo 3 months of therapy with 
assessments at 1,  3, 6 and 12 months after the activation of the implanted device. All current 
subjects or those who have completed their 6-month visit will be offered to return for an 
additional 12-month visit.  This would increase their commitment to the study to 14 months 
Baseline assessments will include measures for pain intensity, use of medication, and 
extent of disability. 
Subjects will undergo a Trial Phase lasting up to 10 days to determine subject’s response to 
DTM SCS. Commercially available stimulation leads and a commercially available external 
neurostimulator (ENS) will be used during the Trial Phase. Subjects will evaluate DTM SCS 
therapy based on pain intensity under optimal stimulation parameters within the 
specifications of the device. Subjects who have a "successful Trial Phase" (defined as a 40% 
or greater pain reduction from Baseline in their upper limb pain) will proceed to permanent 
implantation of a SCS system. 
The implanted INS will be activated within 14 days after surgical procedure and SCS therapy 
will be evaluated for the next 12 months. Activation of the device marks the initial time 
point for effectiveness evaluation of the study therapy after implantation. Assessments of 
pain intensity, use of medication and study-related adverse events will be made through 
the 12 month following Device Activation. Additionally, a 3, 6 and 12months after Device 
Activation, subjects will also be assessed for extent of disability, Patient Global Impression 
of Change, subject satisfaction and paresthesia. All current subjects or those who have 
completed their 6-month visit will be offered to return for an additional 12-month visit.  
This would increase their commitment to the study to 14 months Figure 1 summarizes the 
sequence of study-related assessments, procedures, and activities. 
B.6.2. PRE-SCREENING/CONSENT/ENROLLMENT 
Medical records of all subjects deemed by the Investigator to be potential candidates for 
the study will be de-identified and sent to a sponsor designated physician for pre-screening. 
De-identified medical records should include detailed medical and surgical history of the 
pain condition under study as well any information about comorbidities. Any imaging 
studies (such as MRI, CT, X-ray) should be included for evaluation of the study candidate.  
Once the site has received confirmation that subject may be an appropriate candidate for 
this study, the site may proceed with the eligibility process. This de-identified pre-screening 
process assists in reducing unnecessary visits for subjects that would not be eligible for this 
study. 
Written informed consent for participation in the study must be obtained from subjects 

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before initiation of any study-related activities, including those that assess eligibility.  
Following informed consent, subjects will be assigned a unique subject identification 
number and will be considered to be enrolled in the study.  Eligibility for advancing to the 
next stage of the study will be evaluated by the site Investigator based on the defined 
inclusion and exclusion criteria. Subjects will be assessed for pain intensity and disability.  
B.6.3. ELIGIBILITY CRITERIA EVALUATION  
The eligibility of subjects who have consented participation will be assessed based on the 
inclusion and exclusion criteria.  Study subjects must meet all of the study inclusion criteria 
and none of the study exclusion criteria to be eligible.  Assessments for eligibility include 
average pain intensity (which will be used as Baseline pain intensity), other pain intensity 
(such as secondary pain or related pain), medication usage, medical records and history, 
and the Investigator’s clinical judgment.  Subjects with confirmed eligibility will proceed to 
Baseline assessment, while subjects who do not will be considered screen failures and 
discontinued from the study.   
 

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Figure 1. A flowchart of the study. 

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B.6.4. BASELINE 
A subject that is eligible to continue into the trial phase according to the inclusion and 
exclusion criteria will be requested to fill out standard questionnaires that will assess extent 
of disability and use of medications.  The medical and surgical history of the subject will 
also be collected. At this visit and subsequent visits, the subject will be assessed for study-
related adverse events, medication usage and will be reminded to not increase pain 
medications from baseline through the 3-Month Visit. Pre-operative assessments will 
follow the standard of care for SCS therapy and be determined by the site Investigator.  
B.6.5. SCS TRIAL PHASE 
Subjects will undergo a Trial Phase with DTM SCS programming. The Trial Phase will last up 
to 10 days. Percutaneous leads will be placed in the epidural space at a vertebral level based 
on the subject’s pain condition and pain pattern as described in the Physician Implant 
Manuals. Stimulation will be delivered from an external neurostimulator (ENS).   
Anterior-posterior (AP) and lateral X-ray imaging will be done following lead placement at 
the beginning of the Trial Phase. The subject should flex forward prior to the final AP and 
lateral X-ray imaging. Additional Imaging may be required if lead migration is suspected 
throughout the trial.  
Stimulation therapy will be as follows: 
• Subjects will be given multiple program groups to try. Each DTM SCS program group 
will have multiple parameters. The stimulation parameters will be within the 
specifications described in the IntellisTM manuals.  Each DTM SCS program group has 
at least two programs with different pulse rate in the 50 to 1,000 Hz range and each 
having a maximum pulse width of 1 ms. The subject will progress through each of the 
program groups until satisfactory pain relief has been reached. The subject will be 
able to adjust the intensity of the stimulation as deemed needed to obtain pain relief.  
If sufficient pain relief is not achieved with the initial program group, the subject will 
be instructed to trial another DTM SCS program group. 
Following the standard of care of SCS, adjustments to a program group may be made based 
on patient feedback following the trialing of a particular program group or set of 
stimulation parameters. The primary factor for assessing response to a given program 
group or stimulation parameters is the subject’s self-reported pain relief.  Adjustments to 
therapy will be attempted until at least 40% self-reported pain reduction from baseline is 
achieved or until conclusion of the trial phase (no more than 10 days). Subjects will be 
assessed for study-related adverse events and medication usage during the duration of the 
Trial Phase.  

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B.6.6. END OF TRIAL ASSESSMENT  
At the end of the Trial Phase, subjects will be assessed for pain intensity under optimal 
therapy parameters. Anterior-posterior (AP) and lateral X-ray imaging may be done at the 
end of the Trial Phase. The subject will be assessed for study-related adverse events and 
medication usage. 
Subjects who have a "successful Trial Phase" (defined as a 40% or greater pain reduction 
from Baseline in the upper limbs pain and the subject would like to move forward to the 
implant phase) will proceed to permanent implantation of a SCS system to evaluate DTM 
SCS programming. Permanent implantation of the IntellisTM SCS system will be scheduled. 
A threshold of 40% for the Trial Phase was predetermined as the minimum pain reduction 
that warrants consideration of a permanent implant and an opportunity to achieve a 50% 
pain reduction as defined in the Individual Subject Success criterion (see Section B.7.3).  
Subjects who did not achieve 40% or greater pain reduction in upper limb and do not 
receive permanent implantation will exit the study after being followed up for two weeks 
after removal of the leads to assess study-related adverse events. 
B.6.7. PERMANENT DEVICE IMPLANT (0-60 DAYS FROM END OF 
SUCCESSFUL TRIAL PHASE) 
As described in section B.6.6, subjects who underwent a successful trial of DTM SCS therapy 
and who agreed to continue into the next stage of the study will proceed to permanent 
implantation stage.  
Permanent percutaneous leads will be placed in the epidural space at a vertebral level 
based on the subject’s pain condition and pain pattern as described in the Physician Implant 
Manuals. The implantable neurostimulator (INS) will be implanted by a trained physician 
according to standard practice and following the Physician Implant Manual for the device.  
Anterior-posterior (AP) and lateral X-ray imaging will be obtained.  The standard practice 
of the study site will be followed for prophylactic pre-surgery antibiotics. Subjects will be 
assessed for study-related adverse events and medication usage.  
B.6.8. DEVICE ACTIVATION (0-14 DAYS FOLLOWING PERMANENT IMPLANT) 
Clinical personnel at the site will assess if healing of surgical wounds is sufficiently 
appropriate to start charging the INS. The INS will be initially programmed to the group 
therapy or set of stimulation parameters that provided adequate pain relief during the Trial 
Phase. Adjustments to therapy may be made based on patient response to a program group 
or set of stimulation parameters. The subject will be provided with instructions on how to 
operate the charger and patient remote control at this visit.  Subjects will be assessed for 
study-related adverse events and medication usage. 

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B.6.9. UNSCHEDULED VISITS 
Unscheduled visits may occur at any time during the study for the assessment of possible 
study-related adverse events, changes in pain medication, and programming adjustments.  
Each unscheduled visit will be documented and recorded in the corresponding case report 
form (CRF). 
B.6.10. TELEPHONE CALLS 
Subjects will be contacted by the study coordinator, via a telephone call, before each study 
visit. The study coordinator will check on the well-being of the subject, remind the subject 
of the upcoming scheduled visit, remind the subject not to change pain medication usage 
prior to the scheduled visit, and remind the subject to contact the Investigator/study staff 
should he/she have any concerns or questions. The telephone calls should be made two to 
three weeks before the scheduled visit. 
B.6.11. 1 MONTH AFTER DEVICE ACTIVATION (± 15 DAYS) 
Subjects will visit the study site where they will be assessed for pain intensity.  Programming 
adjustments may be made, as needed. Anterior-posterior (AP) and lateral X-ray imaging 
may be done if significant lead migration is suspected. Subjects will be assessed for study-
related adverse events and medication usage.  
B.6.12. 3 MONTHS AFTER DEVICE ACTIVATION (± 21 DAYS) 
Subjects will visit the study site where they will be assessed for pain, other pain (if 
applicable), extent of disability, Patient Global Impression of Change, and subject 
satisfaction.  Paresthesia generated by the stimulator will be assessed. Programming 
adjustments may be made, as needed.  Anterior-posterior (AP) and lateral X-ray imaging 
will be done. Subjects will also be assessed for possible study-related adverse events and 
medication usage. If there are no ongoing study-related adverse events, the subject will 
complete the study at this visit. In situations where there is an ongoing study-related 
adverse event, subjects will be followed until resolution of that adverse event or 
determination that the subject’s condition is stable, at which point the Study Completion 
CRF should be completed. 
 
B.6.13. 6 MONTHS AFTER DEVICE ACTIVATION (± 31 DAYS) 
.  The 6 Months visit will consist of the same assessments as the 3-month visit except the 
anterior-posterior (AP) and lateral X-ray imaging is optional.  Subjects will visit the study 
site where they will be assessed for pain, extent of disability, quality of life, Patient Global 

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Impression of Change, and subject satisfaction.  Paresthesia generated by the stimulator 
will be assessed. Programming adjustments may be made, as needed.  Subjects will also be 
assessed for possible adverse events and medication usage.  In situations where there is an 
ongoing study related adverse event, subjects will be followed until resolution of that 
adverse event or determination that the subject’s condition is stable.  
However, all subjects who remain implanted at the time of Study Completion will be offered 
to return for an additional visit 12-months after device activation. 
Following the last scheduled study visit, subjects will be followed by their pain physician at 
regular intervals, as dictated by standard of care at each site, in order to facilitate pain 
management, stimulation adjustments, possible revisions and/or replacements of 
neurostimulation components. Any additional non-study related monitoring of the subject 
will be the responsibility of the subject’s personal physician, as dictated by reasonable 
medical care. 
B.6.14. 12 MONTHS AFTER DEVICE ACTIVATION (± 31 DAYS) 
Subjects will be offered an optional visit at 12 months after device activation. This visit will 
consist of the same assessments as the 6-month visit.  Subjects will visit the study site where 
they will be assessed for pain, extent of disability, quality of life, Patient Global Impression 
of Change, and subject satisfaction.  Paresthesia generated by the stimulator will be 
assessed. Programming adjustments may be made, as needed.  Subjects will also be 
assessed for possible adverse events and medication usage.  In situations where there is an 
ongoing study related adverse event, subjects will be followed until resolution of that 
adverse event or determination that the subject’s condition is stable.  
Following the last scheduled study visit, subjects will be followed by the Investigator at 
regular intervals, as dictated by standard of care at each site, in order to facilitate pain 
management, stimulation adjustments, possible revisions and/or replacements of 
neurostimulation components. Any additional non-study related monitoring of the subject 
will be the responsibility of the subject’s personal physician, as dictated by reasonable 
medical care. 
 
 
B.6.15 OTHER ASSESSMENTS AND INFORMATION 
At any time during the study, if lead migration is suspected, the subject may have additional 
AP and lateral X-rays taken to confirm the new lead position in order to aid the Investigator 
in determining a course of action. 
Paresthesia testing may also be performed to assess lead location and therapy coverage of 
pain areas. Programming adjustments may be made based on patient feedback following 
assessment. 

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Additional information on Medication Usage: 
• The Investigator will instruct all subjects to take the Baseline doses of pain medication 
until the 3-Month Visit.  However, after Device Activation Visit, the Investigator may 
reduce the dose of pain medication if the subject is benefitting greatly from DTM SCS 
therapy and not benefitting from Baseline dose pain medication. 
o Subjects should not fluctuate medication usage nor dosages even if the dose is 
at or below Baseline doses. The Investigator/Study staffwill instruct all subjects 
to maintain stable dosing of medication for at least two weeks prior to 
scheduled follow-up visits. 
• Following trial and permanent implants, the clinical site’s standard practice for 
prophylactic pre-surgery antibiotics and post-surgery pain medications will be 
followed. Investigators/Study staff will instruct subjects not to change usage of any 
other concomitant pain medications. 
Remote data collection from the subjects is allowed. This should be evaluated on a case 
by case basis, pending Investigator’s approval based on safety and clinical condition. 
Subjects who are not demonstrating study compliance, e.g. not returning phone calls, not 
charging device or turning the device off should not be mailed study questionnaires until 
they demonstrate compliance with the study. The site should continue to contact the 
subject and ensure compliance before mailing the questionnaires. The communications 
will be documented in the source worksheets. Remote visits would apply to any visit that 
could be conducted remotely without the subject being present, including remote 
programming, if available. Procedural visits (trial and IPG) and any unscheduled visits 
required for study-related adverse events would continue to be performed in office 
where possible. 
• Visit windows remain in place and should be maintained as much as possible. 
Subjects should be contacted via phone to collect AEs, medications and 
concurrent procedures. All questionnaires required at a visit should be obtained 
via phone, email or via mail based on site and/or subject preference. 
• If by phone: site staff will read each question to the subject and record their 
answers. The site staff should initial and date the bottom of each form and 
indicate that is was completed via phone. 
• If by email: the site staff should send the study questionnaires. Subjects can either 
print and manually complete or complete the forms electronically. 
• If manually completed (printed): the subject will be instructed to initial and date 
each page and scan and email or mail the responses back to the site. 
• If the forms are completed electronically: the subject will be instructed to 
complete the questionnaires and return the responses to the site as soon as 
possible, ideally, within 3 business days. 

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• If the questionnaires are sent in hard copy by mail: the subject should be 
instructed to complete the questionnaires and initial and date each page after 
completion and return to site as soon as possible. Ideally, within 3 business days 
of receipt. 
• Source documentation should clearly describe the process utilized for each 
subject at each visit when these alternative methods are utilized.  
B.6.16. DEVICE EXPLANT 
At any time during the study, a subject may elect to withdraw from the study and have the 
SCS device system explanted.  Additionally, an Investigator may elect to explant a device 
due to an adverse event. 
The Investigator must follow the appropriate guidelines set forth by the manufacturer of 
the device for returning the explanted device and/or lead(s) as well as the accessories 
(charger, patient remote control). 
B.6.17. EARLY SUBJECT WITHDRAWAL 
Although efforts will be made by Investigators and study staff to encourage eligible subjects 
to remain enrolled in the study, subjects may withdraw early from the study for a number 
of reasons, including but not limited to: 
• Failure of SCS Trial Phase 
• Subject request 
• Investigator request 
• Subject lost to follow-up 
• Subject’s death 
• Adverse events (e.g., intolerable adverse event occurrence that forces subject to stop 
participation in the study) 
If a subject is considering withdrawing from the study due to unsatisfactory effectiveness 
of DTM SCS programming, the Investigator will attempt to improve therapy during a study 
visit. When a subject is withdrawn early from the study, a Study Termination CRF will be 
completed describing the reason for discontinuation.  Study staff will contact subjects to 
remind them about their scheduled visits and make sufficient efforts to locate a subject 
that is not responding to a contact call. If a subject has withdrawn consent for the study, or 
is lost to follow-up, the completion of this visit is not required.  In situations where study 
withdrawal is due to a study-related adverse event, subjects will be followed until 
resolution of the adverse event or determination that the adverse event is not likely to 
change. 
B.6.18. STUDY COMPLETION 
All subjects enrolled in the study are expected to complete all scheduled visits through the 

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follow up visit 12 Months after Device Activation.  However, all subjects who remain 
implanted at the time of Study Completion will be offered to return for an additional visit 
12-months after device activation.  A Study Completion CRF should be completed at the 
end of this visit unless they decide to remain in the study. If the subject decides to decline 
the additional 12-month visit and there is an ongoing study related adverse event, subjects 
will be followed until resolution of that adverse event or determination that the adverse 
event is not expected to change.  
Subjects who decide to complete the 12-month visit would also be followed equivalently 
in cases of ongoing study related adverse events. 
B.6.19. STUDY SUSPENSION AND TERMINATION 
Subjects will be considered to have completed all study requirements following the 
completion of the follow up visit 3 Months after Device Activation.  All subjects who remain 
implanted at the time of Study Completion will be offered to return for an additional visit 
6-months after device activation. 
Each clinical site will be considered to have completed study requirements at the end of 
the required monitored close out visit.  The study will be considered terminated when all 
of the requirements of this Clinical Study Plan have been fulfilled, all close out visits have 
been completed and all Sponsor and Investigator reports have been issued and reported to 
the IRB. 
The Sponsor, the Investigators, or the IRB(s) may suspend or terminate the study early at 
any time.  If the study is suspended or terminated prematurely, all subjects that are still 
enrolled will be terminated from the study. A Study Completion CRF will be completed 
noting that the study has been terminated.  If there is an ongoing study-related adverse 
event, the subject will be followed until resolution of the adverse event or determination 
that the adverse event is not likely to change.  
Subsequent follow-up of the subjects after study completion will be the responsibility of 
the subject’s personal physician.   
The Sponsor reserves the right to terminate the study but intends only to exercise this right 
for reasons related to the protection of subjects or valid scientific or business reasons.  The 
Sponsor will notify Investigators and IRBs in writing in the event of study termination.   
The Sponsor reserves the right to stop the enrollment of subjects at any clinical site at any 
time after the clinical site initiation. Possible reasons for suspending or terminating a 
clinical site may include, but are not limited to 
• Non-compliance by Investigator  
• Failure to obtain proper written informed consent 
• Repeated failure to complete or submit CRFs in a timely manner 
• Failure to report study-related serious adverse events (SAEs) or unanticipated 
adverse device events (UADEs) to the Sponsor within 48 hours of knowledge of the 
event and to reviewing IRB in accordance with its policies 

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• Repeated failure to comply with clearance of queries generated during monitoring of 
the study 
• Inactivity 
B.7. STUDY ENDPOINTS 
B.7.1. DEFINITION OF ANALYSIS POPULATIONS  
All subjects who receive a permanent SCS system implant and complete the study without 
any major protocol deviations (that would render their data unevaluable).  
B.7.2. EFFECTIVENESS ASSESSMENT DEFINITIONS 
Primary Effectiveness Assessment:  For subjects who have a successful Trial Phase and 
receive a permanent implant, the Primary Effectiveness Assessment occurs at the follow 
up visit 3 months after Device Activation.   
B.7.3. PRIMARY ENDPOINT 
Pain rating on the 10 cm Visual Analog Scale (VAS) is considered the primary outcome 
measure.  VAS is the most widely used outcome measure in assessing pain due to its 
documented reliability and validity, ease in administration, and minimal training 
requirements for the administrator. 
The primary effectiveness endpoint is the percentage of implanted subjects who respond 
to DTM SCS therapy at 3-months after device activation. 
An Individual Responder is a subject that reports a decrease in upper limb pain VAS 
score by at least 50% at 3 months after activation of the permanent SCS system 
(Device Activation) as compared with Baseline measurement.  
B.7.4. SECONDARY ENDPOINTS 
The following secondary endpoints will be evaluated:  
• Change from Baseline in upper limb pain mean VAS score determined at the 3-month 
visit after device activation. This is calculated as: Change from Baseline in Upper 
Extremities Pain VAS = 3-Month Visit Pain VAS – Baseline Pain VAS. A negative result 
reflects a decrease in Pain VAS score, while a positive result reflects an increase in 
Pain VAS score. 
• Change from Baseline in extend of disability as measured by mean Pain Disability 
Index (PDI), evaluated at 3 months after device activation. 
• Frequency of treatment emergent adverse events. 

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B.7.5. ADDITIONAL DATA COLLECTION  
The following will also be collected: 
• Comparison of mean change from Baseline in upper limb pain mean VAS score 
evaluated at 1, 3, 6 & 12months after device activation. 
• Subject Satisfaction, evaluated at 3, 6 & 12months after device activation. 
• Patient Global Impression of Change, evaluated at 3, 6 & 12 months after device 
activation. 
• Quality of paresthesia at 3, 6 & 12 months.  
• Comparison of mean change from baseline in other pain mean VAS score evaluated 
at 3, 6 & 12- months after device activation (if available) 
• Activity level based on IntellisTM Adaptive-Stim data log. 
 
B.8. EVALUATION CRITERIA 
B.8.1. EFFECTIVENESS 
Results of the tests and standard questionnaires will be recorded in Case Report Forms at 
Baseline and during follow-up visits. Changes from Baseline will be calculated.   
Effectiveness will be measured for each subject using the following tests: 
• Pain 
• Visual Analog Scale (VAS, 10 cm) at Baseline, End of Trial Phase, Months 1, 3, 6 and12 
monthsDisability 
Pain Disability Questionnaire at 3, 6 and 12 months 
• Impression of Change in Quality of Life 
Patient Global Impression of Change at 3, 6 and 12 months 
• Satisfaction with Therapy 
Subject Satisfaction Questionnaire at 3, 6 and 12 months 
• Paresthesia generated by the stimulation 
Paresthesia Questionnaire at 3, 6 and 12 months 
Study personnel will be appropriately trained for administration of each test.  
  

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B.8.3. SAFETY 
Safety will be assessed by characterizing study-related adverse events at all study visits with 
descriptive statistics. 
B.8.3.1 DEFINITIONS 
An adverse event (AE) is any untoward medical occurrence in a subject associated with 
the use of the therapy under the study whether or not related to the IntellisTM SCS system 
or the study procedures. An AE is also any event related to any underlying medical 
condition, present at baseline, which increases in severity or frequency by a clinically 
meaningful amount during the study as determined by the Investigator. Study-related is 
defined as relating to device, procedure or therapy. 
For all study-related adverse events, the Investigator will provide an assessment of the 
adverse event, its seriousness, treatment/intervention provided, relationship to the 
device/procedure/therapy, and resolution. 
As the effectiveness measure in this study is upper limb pain, upper limb pain do not need 
to be reported as an adverse event unless it meets the definition of a serious adverse 
event. Investigators may, however, report any other study pain-related adverse events 
during the study.   
A serious adverse event (SAE) is an adverse event that  
• Leads to death 
• Leads to serious deterioration in the health of the subject, that either results in  
o a life-threatening illness or injury (life-threatening is defined as at risk of death at 
the time of the event), or 
o a permanent impairment of a body structure or a body function, or 
o in-patient hospitalization or prolongation of existing hospitalization (in-patient 
hospitalization is defined as a hospital admission for a period of greater than 24 
hours), or  
o medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function, 
• Leads to fetal distress, fetal death, or a congenital abnormality or birth defect 
An unanticipated adverse device event (UADE) is a serious adverse event that was not 
previously identified in nature, severity, or degree of incidence in the Clinical Study Plan, 
or any unanticipated serious problem associated with a device that related to the rights, 
safety, or welfare of subjects. 
Known adverse events related to the device, procedure or therapy are listed in the section 
C. (Risk Analysis) of this Clinical Study Plan. 

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B.8.3.2 REPORTING 
Reported AEs, SAEs and UADEs will be assessed and captured from enrollment through 
the completion of the study on the Adverse Event Source Worksheet. Study-related is 
defined as relating to the device, procedure or therapy. The assessment/evaluation can 
be performed initially by a designee, but the Investigator will make the final 
determination.  
Only adverse events that are evaluated by the Investigator to be study-related will be 
captured on the CRF. 
All 
study-related 
adverse 
events 
will 
document 
seriousness, 
severity, 
treatment/intervention provided, relationship to the device/procedure/therapy, and 
resolution.   
AEs and SAEs will be reported as required by the IRB. 
As would be the common practice when using commercial medical devices, device -
related AEs may be reported by the site (per their institutional policy) to the Customer 
Service or Technical Support of Medtronic as specified in the manufacturer's 
labeling/manuals. 
Data Monitoring Committee will not be used as this is a post-market open label study and 
will adhere to all IRB reporting requirements and the device manufacturer’s reporting 
requirements. 
B.9. DATA COLLECTION AND ANALYSIS 
B.9.1. DATA COLLECTION 
Study data will be collected using paper CRFs. Each data field is expected to have a verifiable 
source document.  Subject confidentiality will be maintained, and each subject will be 
identified by the assigned study subject number.  Subject names will not be published. 
Data collection is summarized in Table 1. 
B.9.2. STATISTICAL ANALYSIS 
There are no formal hypotheses evaluated in this study. All baseline and outcome data will 
be reported using summary statistical methods. Descriptive statistics will be used to 
summarize baseline and outcome data collected during the study.  Continuous variables 
will be summarized using means, standard deviations, and ranges.  Categorical variables 
will be summarized in frequency distributions. 

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Table 1. Schedule of Study Activities 
 
 
Pre-Trial Phase 
Trial Phase 
Permanent Phase 
 
 
Activity 
Enrollment 
Baseline 
Start Trial Phase 
End Trial Phase 
(up to10 days 
after trial 
starts) 
Permanent 
Implant (up to 
60 days after 
end of trial) 
Device 
Activation (0-14 
days after 
implant) 
1-month visit 
(±15 days after 
activation) 
3 months visit 
(±21 days after 
activation) 
6 months visit 
(±31 days after 
activation) 
12 
months 
visit (±31 
days after 
activation
) 
Informed Consent 
X 
 
 
 
 
 
 
 
Xb) 
Xb) 
Pain Intensity Evaluation 
(VAS) 
X 
 
 
X 
 
 
X 
X 
X 
X 
Medication Use 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Medical/Surgical History 
X 
X 
 
 
 
 
 
 
 
 
Eligibility Criteria Evaluation 
X 
 
 
 
 
 
 
 
 
 
Pain Disability Questionnaire 
 
X 
 
 
 
 
 
X 
X 
X 
AP/Lateral x-ray imaging 
 
 
X 
[X] 
X 
[X] 
[X] 
X 
[X] 
[X] 
Paresthesia Questionnaire 
 
 
 
 
 
 
 
X 
X 
X 
Patient Global Impression of 
Change 
 
 
 
 
 
 
 
X 
X 
X 
Subject Satisfaction 
 
 
 
 
 
 
 
X 
X 
X 
Adverse Event Monitoring 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Device Programming 
 
 
X 
 
 
X 
[X] 
[X] 
[X] 
[X] 
Device Programming Log 
 
 
 
[X] 
 
 
[X] 
[X] 
[X] 
[X] 
Study Completion 
 
 
 
Xa) 
 
 
 
[X] c 
[X]c 
Xc 
[X] Optional activity. 
a) For subjects that do not have a successful Trial Phase.  
b) Some subjects may need to be reconsented to complete these visits.  
c)  Some subjects were originally consented to complete the study at the 3 or 6 month visit and may not consent for additional 
visit.

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C.  RISK ANALYSIS 
C.1. DESCRIPTION AND ANALYSIS OF ALL INCREASED RISKS TO SUBJECTS 
DTM SCS programming approach will be used with a commercially available, FDA approved, 
IntellisTM SCS system, with parameters within the specifications for the indicated use. 
Anticipated potential adverse events resulting from the study are expected to be in line with 
adverse events already documented for SCS using a conventional programming approach.  
There are known risks associated with the use of any SCS system.  Known risks are associated 
with the implant procedure, the stimulation, the implanted device (not associated with 
stimulation) and external devices such as the charger and remote control. These are typical of 
commercial SCS systems. Subjects will be informed of these anticipated risks in the study 
consent process. 
Risks of Surgery: 
Implanting a neurostimulation system has risks similar to spinal procedures, including spinal 
fluid leak (spinal fluid collection under the skin), headaches, swelling, bruising, bleeding, 
infection, or paralysis.  
Subjects on anticoagulation therapy may be at higher risk for problems after surgery such as 
hematomas that could result in paralysis. 
Spinal Cord Stimulation Risks: 
The implantation of a spinal cord stimulation system involves risks that are similar to other 
spinal procedures. In addition to those normally associated with surgery, implantation or use 
of a neurostimulation system includes, but is not limited to, the following risks: 
• Allergic or immune system response to the implanted materials 
• Infection 
• Lead or neurostimulator erosion through the skin or migration 
• Leakage of cerebrospinal fluid 
• Loss of pain relief may return patients to their underlying pain condition 
• Persistent pain at the neurostimulator site 
• Placement of the epidural lead is a surgical procedure that may expose patients to 
risks of epidural hemorrhage (bleeding), hematoma, or paralysis 
• Radicular chest wall stimulation 
• Seroma (fluid collection in pocket where stimulator is placed) or hematoma at the 
neurostimulator site 

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• Change in stimulation, possibly related to cellular changes around the electrode(s), 
shifts in electrode position, loose electrical connections, lead fractures, which has 
been described by some patients as uncomfortable stimulation (jolting or shocking 
sensation) 
• Over time, there could be changes in the level of symptom control. In most cases, the 
physician can correct these changes without surgery. 
• Formation of excessive tissue around the lead in the epidural space can result in 
delayed spinal cord compression and paralysis, requiring surgical intervention. Time 
to onset can range from weeks to many years after implant. 
• The safety of this therapy is unknown for pregnancy, unborn fetus, or delivery 
• Stimulation-dependent gastrointestinal symptoms such as diarrhea, incontinence or 
constipation 
• Stimulation-dependent bladder symptoms such as urinary retention, incontinence or 
frequency 
• Unexpected changes in stimulation - Electromagnetic interference, changes in 
posture, and other activities can cause a perceived increase in stimulation 
System Revision Risk: 
The Intellis Neurostimulator may require replacement in 9 years or earlier, regardless of the 
number of times the neurostimulator is recharged.  It is possible that the system will need to 
be revised (explanted, replaced, or repositioned) earlier than 9 years.  Possible reasons for 
revision/explant may include infection, malfunction, and migration of the system 
components.  The risks associated with system revision are equivalent to the commercially 
available systems.    
Pregnancy Risks 
Pregnant women are not able to take part in this study.  Female subjects must agree to not 
become pregnant during the study by using a medically acceptable method of birth control. If 
a subject becomes pregnant during this study, there may be risks to the unborn child that are 
not yet known.  Subjects will be advised and encouraged to notify the study doctor 
immediately if they think they are or have become pregnant.  Subjects that become pregnant 
during the study will be instructed to turn the neurostimulator “OFF” and will be exited from 
the study. 
Radiographic Imaging 
As part of the study, subjects maybe required to have fluoroscopic or X-ray images taken of 
their thoracic spine.  in addition to the imaging conducted to implant the leads.  This may be 
beyond what is standard of care.  The risk associated with these additional images has been 
considered and determined to be minimal since the total radiation dose will be approximately 
the same as one CT scan of the abdomen.     
Study Risk Control Measures  

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The following will be done to mitigate risks associated with the implanted system: 
• Investigators who are experienced with spinal cord stimulation implantation 
techniques will be utilized 
• Instructions will be given to the study participants to ensure they can properly use 
the patient programmer and recharger system 
• Subjects can turn off stimulation at any time during the study with the patient 
programmer or recharger 
• Periodic monitoring of the study participants 
• Written materials that contain precautions, warnings, and contraindications, as 
well as instructions on the use of the devices will be available and/or provided to 
the clinicians and subjects 
Since the efficacy measure in this study is intensity of pain in the upper limbs, pain in these 
areas does not need to be reported as an adverse event unless it meets the definition of a 
serious adverse event. However, Investigators may, at their discretion, report any other pain-
related adverse events during the study.   
C2.  MINIMIZATION OF RISKS 
Neurostimulation therapies, such as SCS, are used as an aid in the management of chronic, 
intractable pain that cannot be effectively managed with medications and/or other 
conservative treatments alone. Patients considered for neurostimulation therapy have 
typically had pain of long duration and have failed multiple therapeutic paths.  
Medtronic has carefully designed and tested the IntellisTM AdaptiveStim Neurostimulation 
Systems to ensure the safety and performance for the treatment of chronic, intractable pain. 
Medtronic has completed an extensive risk analysis to ensure the identification of potential 
hazards and subsequent mitigation of these hazards to eliminate them entirely or reduce 
them to an acceptable level.   
The risks associated with the surgical implantation of the device, device use, and device 
failures are the same as those observed for commercially available SCS devices. With an 
existing pre-market application approval for the commercially available IntellisTM 
AdaptiveStim Neurostimulation Systems, an established safety profile of probable benefit 
outweighing risk already exists for SCS Therapy for chronic back and/or leg pain. In most cases 
implantation of SCS is a reversible procedure and the system can be turned off or removed. 
Moreover, stimulation parameters are adjustable to minimize or reverse complications and 
maximize therapeutic effects. System output and programming parameters used with the 
proposed stimulation parameters are within the range of the commercially available Intellis 
AdaptiveStim Neurostimulation Systems. The anticipated benefits of the clinical outcomes of 
SCS therapy per the study design outweigh the overall risk. 

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Study Investigators are experienced in the diagnosis and treatment of chronic pain, have 
proper surgical and clinical training and will take adequate steps to ensure subject safety 
throughout the entire study.   
Investigators and study personnel will receive product training to become familiar with the 
components of the IntellisTM SCS systems and their functions. They will also receive training 
on assessment tools.  Investigators will also be reminded that the risk of serious injury to the 
patient increases as location of the selected needle insertion site progresses up the vertebral 
column—from a lower risk at a lumbar location to a higher risk at a cervical location.  
Therefore, they should select a vertebral location that provides the widest and easiest access 
to the epidural space during needle insertion to reduce the risk of serious patient injury 
resulting from direct trauma to the spinal cord. All Investigators and study personnel must 
provide evidence of training in Good Clinical Practice (GCP) in the conduct of clinical trials with 
human participants.  
C3.  POTENTIAL BENEFITS 
It is possible that an individual subject will experience no direct benefit from participating in 
the study. However, if a subject is benefiting from therapy, he/she will be allowed to keep the 
implanted device and accessories after completion of the study, with post-study care 
conducted by the subject’s personal physician. 
D.  DESCRIPTION OF THE DEVICE 
D.1. EACH IMPORTANT COMPONENT, INGREDIENT, AND PROPERTY OF THE 
DEVICE 
D.1.1. DEVICE SYSTEM OVERVIEW 
The Intellis™ system is a totally implantable spinal cord stimulation system that is indicated 
as an aid in the management of chronic intractable pain of the trunk and/or limbs. The 
system has been approved by the FDA and is available for commercial use.  
The Intellis system consists of a rechargeable implantable neurostimulator (INS) with 16 
output channels.  The INS is implanted in a subcutaneous pocket and is capable of 
stimulating the dorsal aspect of the spinal cord when used with one or two 8-contact 
percutaneous leads located in the epidural space. The INS can be controlled by a Patient 
Programmer and/or a Clinician Programmer.   
Before permanent implantation, a trial phase of therapy lasting up to 10 days is required. 
Components of the system during trial include an External Neurostimulator (ENS) capable 
of delivering the same stimulation as the INS, and Stimulation Leads. Other components of 

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the system include Clinician Programmer, Communicator, Patient Programmer, Extensions, 
Charger and charging system, and surgical accessories. 
D.1.2. DEVICE SYSTEM DETAILS  
 
Only FDA approved, commercially available components will be used for the study. 

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D.1.2.1 MAJOR COMPONENTS 
Implantable Neurostimulator: The Intellis neurostimulator (INS, Model 97715, 
Medtronic, Minneapolis MN) will be used for the study. The INS is a multi-programmable, 
rechargeable device that delivers stimulation through one or two 8-electrode leads. The 
stimulation settings are stored in programs. A program is a specific combination of pulse 
width, rate, and amplitude settings acting on a specific electrode combination (up to 16 
electrodes per program). Each of the 16 electrodes in the leads can be set to be a cathode, 
an anode, or to remain off. The INS is powered by a Li-Ion rechargeable battery.  The INS 
is capable of stimulating the dorsal aspect of the spinal cord through the electrodes in the 
leads that are connected to the output terminals of the INS. The electrical pulses used for 
stimulation are generated using a single current source.  The INS is designed to produce 
charge-balanced, biphasic rectangular pulses.  
The battery is recharged using an external charger that uses transcutaneous RF energy 
transmission. The INS is capable of communicating with the Charger to control the 
recharging function.   
The INS communicates with the Clinician Programmer and Patient Programmer (also 
called Patient Remote Controller). The Clinician Programmer is used to program the INS 
and the ENS. The Patient Programmer is used by the subject to control some of the 
therapy parameters, change therapy programs, and turn stimulation on and off. 
External Neurostimulator (ENS) for Trial Phase: The Medtronic Model 97725 Wireless 
External Neurostimulator (ENS) is part of a neurostimulation system used for trial 
stimulation outside of the operating room. The ENS is powered by two standard alkaline 
AAA batteries. The ENS is connected to leads implanted in the subject. The subject uses 
the ENS during the Trial Phase to evaluate the effectiveness of SCS therapy prior to 
receiving a permanent implant. The ENS also communicates with the Clinician 
Programmer system and Patient Remote Controller, similar to the INS.  
Clinician Programmer System:  The Medtronic Model A710 Intellis™ clinician programmer 
application resides on a tablet and is intended to be used by healthcare professionals to 
program the ENS (Model 97725) and IntellisTM INS (Model 97715 and 97716) for pain 
therapy. The Clinician Programmer requires the use of a Communicator (Model 8880T2) 
to communicate with the INS.  
Patient Programmer: The Patient Programmer (Model 97745), also called Patient Remote 
Controller, is a handheld unit able to communicate with the INS or ENS.  The Patient 
Programmer is powered by two standard AA alkaline batteries during the Trial Phase and 
a rechargeable battery after implant of the INS. The Patient Programmer is used by 
subjects to select the SCS therapy program to be applied, to turn on or off the INS or ENS, 
and to change some of therapy parameters such as stimulation amplitude.   
Charging System:  The Charging system (Model 97755) is used by the subject to 
transcutaneously charge the INS battery.  It is a portable device powered by a 
rechargeable battery and can be held in one hand. The charging system used in this study 

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is a commercially available charging system manufactured by Medtronic (Minneapolis, 
MN) and fully compatible with the study INS. 
Stimulation Leads and Lead Extensions:  The study will use commercially available 
percutaneous eight-electrode leads manufactured by Medtronic (Vectris, Minneapolis, 
MN) and compatible with the INS and ENS to be used in this study. The leads are 
positioned percutaneously in the epidural space of the subject and are used for delivering 
the stimulation field to the dorsal aspect of the spinal cord. The percutaneous leads are 
intended to be single use. Temporary or permanent percutaneous leads may be used 
during the Trial Phase of the study. The proximal end of these leads connect directly to 
the ENS. Permanent leads will be used during the Permanent Phase of the study. These 
may be connected to a Lead Extension. The leads or lead extensions are tunneled 
subcutaneously to connect to the INS. Commercially available lead extensions 
(Medtronic, Minneapolis, MN) compatible with the percutaneous leads and INS may be 
used in this study. As with any spinal procedure, the risk of serious injury to the patient 
(e.g, hemorrhage, hematoma, or paralysis) increases as location of the selected needle 
insertion site progresses up the vertebral column—from a lower risk at a lumbar location 
to a higher risk at a cervical location. Select a vertebral location that provides the widest 
and easiest access to the epidural space during needle insertion to reduce the risk of 
serious patient injury resulting from direct trauma to the spinal cord. 
D.1.2.2. SURGICAL ACCESSORIES 
The surgical accessories that will be used in the study will be commercially available 
devices. 
Torque Wrench:  A commercially available Torque Wrench is used to tighten the screws 
that lock a percutaneous lead into the INS and/or a lead extension. It also tightens the 
screws that lock the lead extension into the INS when this is used. 
Lead anchors:  Lead anchors may be used to possibly prevent lead migration and/or lead 
strain. These are used to anchor the percutaneous leads to the supraspinous ligament or 
fascia. Lead anchors used in this study are commercially available (Medtronic, 
Minneapolis, MN) and designed to slide freely over the lead length to the required fixation 
position. Surgical sutures are then tied around the anchor clamping the sleeve in place on 
the lead.   
Insertion Needle:  Percutaneous leads are implanted in the dorsal epidural space using 
insertion needles.  An insertion needle contains a cannula and stylet that facilitate access 
to the spinal canal for lead placement.  The insertion needle is a 14G epidural needle with 
a thin wall and a modified Touhy non-coring tip.  The cannula and stylet are designed to 
lock together and maintain the orientation of the tip of each component. The hub of the 
insertion needle has a standard luer fitting. 

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Stylets:  Stylets are used to push and “steer” a percutaneous lead into the desired place 
within the epidural space.  The distal end of the stylet could be straight or curved.  The 
implanter is able to use either one in order to comfortably maneuver a percutaneous lead 
through the epidural space until it reaches the desired implant location. 
Tunneling Tool:  A Tunneling Tool is used to create a subcutaneous tunnel that directs the 
percutaneous leads or lead extensions from the midline incision to the leads from the INS 
implant site.  This is a single use tool.  
INS Template:  The INS Template is an aid to be used for the implanter intended for proper 
sizing of the INS pocket within each subject. 
INS Port Plug:  An INS Port Plug is used to seal the port of the INS that is not in use when 
only one percutaneous lead is implanted. 
Lead Blank:  A Lead Blank is an optional aid made out of flexible stainless steel that has 
an outer diameter similar in size to the percutaneous lead. A lead blank can be optionally 
used to clear a path for the introduction of a percutaneous lead into the epidural space.  
D.2. PRINCIPLE OF OPERATION OF THE DEVICE 
A commercially approved IntellisTM SCS system approved by the FDA for the treatment of 
intractable chronic pain of the trunk and limbs.  The study will utilize this device within the 
approved specified parameters. Spinal cord stimulation therapy for pain management has 
been used for more than four decades. Its efficacy and safety has been widely documented.  
D.3. LABELING 
Instructions for Use:  The study devices will be used in accordance to their Physician Manual. 
D.4. ANY ANTICIPATED CHANGES IN THE DEVICE 
There are no anticipated changes at this time. 
 
E.  ADMINISTRATIVE PROCEDURES 
E.1. MONITORING  
Clinical site monitoring is conducted to ensure compliance with Good Clinical Practice (GCP) 
guidelines to protect the rights and well-being of trial participants, that the reported trial data 
are accurate, complete, and verifiable, and that the conduct of the trial is in compliance with 
the currently approved protocol/amendment(s), and with applicable regulatory 
requirement(s).   

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E.1.1. STUDY CLINICAL MONITOR 
The Sponsor will assign a Clinical Monitor(s) in order to fulfill the required Sponsor and 
monitoring responsibilities according to the Study Monitoring Plan. The Study Monitoring 
Plan describes in detail who will conduct the monitoring, at what frequency monitoring 
will be done, at what level of detail monitoring will be performed, the distribution of 
monitoring reports, and key monitoring activities and specifies the data to be reviewed 
over the course of the clinical study. The monitoring plan will facilitate compliance with 
Good Clinical Practices (GCP) and other relevant guidelines. The clinical study monitors 
will conduct monitoring visits in accordance with this plan. Monitoring may be conducted 
on-site or remotely.  
E.1.2. MONITORING PROCEDURES 
Monitoring visits to the clinical study sites will be made either remotely or on-site 
periodically and according to the monitoring Plan.  These visits will ensure that 
Investigators and their staff understand and accept their defined responsibilities, 
assess compliance with current GCP guidelines, evaluate clinical trial progress, assess 
the continued acceptability of the site facilities, evaluate compliance with this Clinical 
Study plan, and verify the data entered on the CRFs.  
Investigators are to maintain, in an appropriate secure location, all source documents 
as required by the Clinical Study plan. Source documents include signed informed 
consents, subject completed questionnaires, laboratory results, supporting medical 
records, and any applicable electronic files.  These source documents will be used by 
the Clinical Monitor at the scheduled monitoring visits to verify information entered 
onto the CRFs. Clinical monitoring activities will include review and resolution of 
missing or inconsistent results to assure the accuracy of the reported data.  Where 
any discrepancies are noted, the Clinical Monitor will generate queries. Discrepancies 
will be resolved with the Investigator and/or an individual designated by the 
Investigator.  If data is incomplete, the Investigator will attempt to obtain the missing 
data.  The original source documents will remain stored in a secure location at the 
clinical sites as designated by the Investigator.   
The safety and welfare of study subjects will be ensured by following the appropriate 
GCP guidelines for informed consent, including proper documentation (Informed 
Consent Form) by following the Clinical Study plan, and by reporting and following up 
study-related adverse events as appropriate. 
The Clinical Monitor will summarize the evaluation and assessment of each 
monitoring visit in written reports. These reports will identify any issues with 
repeated data recording or reporting and will specify clear recommendations for 
resolution of noted deficiencies. 

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The conduct and monitoring of the clinical investigation will be conducted in accordance 
with the Sponsor’s internal procedures.   
E.2. DATA QUALITY ASSURANCE 
Data collection is the responsibility of the clinical trial staff at the site under the supervision 
of the site Investigator. The Investigator is responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported. The subject data will be 
entered on paper CRFs following the study visits. Study visit worksheets will be provided for 
use as source document worksheets for recording data for each participant enrolled in the 
study.  All source documents should be completed in a neat, legible manner to ensure 
accurate interpretation of data. Data recorded on the CRFs should be consistent with the 
data recorded on the source documents. Data will be reviewed to identify inconsistent or 
missing data as well as study-related adverse events.  Data discrepancies will be addressed 
by written communication or by telephone with the clinical site and/or during clinical site 
monitoring visits. The Sponsor and representatives of regulatory authorities are permitted to 
access study documents (e.g. Clinical Study plan, CRFs, medical records/files) as needed. All 
attempts will be made to preserve the privacy and confidentiality of subjects. 
E.3. STUDY CONDUCT 
The Investigator agrees that the study will be conducted according to this investigation plan, 
the principles of GCPs as outlined in the United States Code of Federal Regulations (CFR) - 21 
CFR Parts 50, 56 and 812, and the Sponsor internal standard operating procedures.  The 
Investigator will conduct all aspects of the study in accordance with all Federal and local laws 
of pertinent regulatory authorities.  
The Investigator will assure correct implementation and conduct of the trial including those 
study-related duties delegated to other appropriately qualified individuals and designated in 
the delegation of authority documentation.  The Investigator will assure that study staff 
cooperates with monitoring and audits, and will demonstrate due diligence in recruiting, 
screening, and retaining study subjects. 
The Investigator will also be responsible for filing an annual study progress report to the IRB 
as per IRB guidelines. The Investigator and/or Sponsor, as required by local regulations, are 
required to report in writing to the IRB, notice of completion, termination, or discontinuation 
of the study. If the study is discontinued for safety concerns, the Investigator and/or Sponsor 
will notify the IRB immediately.  
The Investigator is also responsible for recording and assessing the relationship to the study 
and the seriousness of study-related adverse events. Investigators must report any study-
related serious adverse event (SAE) to the sponsor within 48 hours of knowledge of the event 
and to the IRB as per their regulations. 

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The Investigator is also responsible for promptly reporting to the Sponsor any deviations and 
exceptions to this Clinical Study plan and to the IRB per their requirements. 
E.4. INFORMED CONSENT MATERIALS 
Informed consent must be obtained from all subjects prior to study participation. Informed 
consent will be obtained by the Investigator or an Investigator-designated healthcare 
professional as per GCP guidelines. An informed consent form (ICF) will be provided to 
potential subjects for their private evaluation. If a subject consents to participate, the ICF must 
be signed by the subject.  Study ICF must be approved by the IRB. Signed ICFs will be retained 
in the subject's study records at the clinical site. Subjects may also be consented via a 
combination of mail and telephone calls. The Investigator or delegate will document the 
telephone calls and follow-up by signing the consent once the subject returns the signed 
consent. Study staff will then provide a photocopy to the subject.  
The ICF will be in compliance with the requirements set forth in 21 CFR 50, Protection of 
Human Subjects. 
E.5 INVESTIGATORS AND INSTITUTIONS 
The clinical Investigators participating in this study will be chosen based on their qualifications 
and experience.   
E.6. AMENDMENTS AND DEVIATIONS 
This Clinical Study plan is to be followed by Investigators and all personnel involved in the 
clinical study.  Any changes to the study covered by this Clinical Study plan must be 
documented on a formal Clinical Study plan amendment prior to implementation in the study.  
Changes to the Clinical Study plan may be initiated by the Sponsor or at the request of an 
Investigator.  A formal change to this study under this Clinical Study plan cannot be initiated 
by Investigator or clinical site personnel without sponsor’s approval, IRB approval, and the 
Investigator’s approval. 
Exception for Emergency Deviation:  An exception to the policy noted 
above is an emergency deviation to the Clinical Study plan that may be 
initiated by the Investigator without prior approval from the Sponsor, 
only in cases where a change is necessary to eliminate any immediate 
apparent hazard to subjects.  Emergency deviations must be reported to 
the Sponsor and the IRB no later than 24 hours following the emergency. 
Deviations from the Clinical Study plan and study requirements (including GCP guidelines) will 
be reviewed by the Sponsor and will be evaluated on an ongoing basis. Appropriate corrective 
actions will be implemented as necessary. 

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E.7. ADDITIONAL RECORD AND REPORTS 
This study will be registered on clinicaltrials.gov. Sponsor/Investigator Records and Reports 
will be maintained and provided in accordance to 21 CFR 812.140 and 812.150.  No additional 
records or reports will be maintained. 

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9. 
REFERENCES 
 
 
 
1 The Global Pain Therapeutics Market Analysis, R&D Pipelines and Competitive Landscape, 
Arrowhead Publishers, 2007, pp. 408. 
2 Institute of Medicine (US) Committee on Advancing Pain Research C, and Education. Relieving 
Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. 
Washington (DC): National Academies Press (US), 2011, pp. 2. 
3 Vos T, Global Burden of Disease Study 2013 Collaborators. Global, regional, and national 
incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and 
injuries in 188 countries, 1990–2013: a systematic analysis for the Global Burden of Disease 
Study 2013. Lancet 2015; 386: 743–800 
4 https://www.hhs.gov/opioids/about-the-epidemic/index.html 
5 Smits H, van Kleef M, Holsheimer J, et al. Experimental spinal cord stimulation and 
neuropathic pain: mechanism of action, technical aspects, and effectiveness. Pain Practice 
2013; 13:154-168.   
6 Deer TR, Mekhail N, Provenzano D, et al. The appropriate use of neurostimulation of the 
spinal cord and peripheral nervous system for the treatment of chronic pain and ischemic 
diseases: the neuromodulation appropriateness consensus committee. Neuromodulation 2014; 
17:515-550. 
7 Deer TR, Mekhail N, Provenzano D, et al. The appropriate use of neurostimulation: avoidance 
and treatment of complications of neurostimulation therapies for the treatment of chronic 
pain. Neuromodulation. 2014; 17:571-597. 
8 Taylor RS, Van Buyten JP, Buchser E. Spinal cord stimulation for chronic back and leg pain and 
failed back surgery syndrome: a systematic review and analysis of prognostic factors. Spine 
(Phila Pa 1976) 2005; 30:152-160. 
 
F.  APPENDICES 
A. Informed Consent Form 
B. Subject Questionnaires