Multi-Center Evaluation of Clinical Outcomes of Pulse Widths <500 μsec and >1000 μsec During a Temporary Spinal Cord Stimulation Trial
Phase: NA
Conditions: Back Pain, Pain
Sponsor: Kettering Health Network

DRAFT 
 
CONFIDENTIAL 
 
9 March 2014 
i 
Multi-Center Evaluation of Clinical Outcomes of Pulse 
Widths <500𝜇𝜇sec and >1000𝜇𝜇sec During a Temporary 
Spinal Cord Stimulation Trial 
Title: 
Multi-Center Evaluation of Clinical Outcomes of Pulse Widths 
<500𝜇𝜇sec and >1000𝜇𝜇sec During a Temporary Spinal Cord 
Stimulation Trial 
Protocol Number: 
TBD 
Device: 
Nuvectra® Algovita® Spinal Cord Stimulation System 
Sponsor: 
The Ohio Pain Clinic 
7076 Corporate Way       
 
 
 
 
 
   
Dayton, OH 45458    
Sponsor Contact: 
Amol Soin, MD 
7076 Corporate Way       
 
 
 
 
 
   
Dayton, OH 45458 
 
 
 
         
drsoin@gmail.com 
 
Study Sites: 
TBD 
 
Medical Monitor: 
Erin Dewenter, RN  
 
 
 
 
                   
Ohio Pain Clinic 
 
 
 
 
                   
7076 Corporate Way 
 
 
 
 
 
 
Dayton, OH 45458 
Date of Protocol: 
TBD 
 
Confidentiality Statement 
The confidential information in this document is provided to you as an investigator or consultant for review by you, your staff, and the applicable 
Institutional Review Board.  Your acceptance of this document constitutes agreement that you will not disclose the information contained herein 
to others without written authorization from   . 
 
 
 

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ii 
Protocol Synopsis 
Sponsor Contact
Information 
Ohio Pain Clinic 
Amol Soin, MD 
7076 Corporate Way 
Dayton, OH 45458 
Study Purpose 
The purpose of this study is to evaluate the effect of pulse widths <500 µsec and
>1000 µsec on clinical outcomes during a temporary SCS trial. 
Study 
Design
and Scope 
The proposed study is a prospective, multi-center, two-arm, randomized,
crossover design to be conducted at up to 10 sites. The study will enroll up to 
100 subjects in order to include up to 10 subjects in the study per site. Subjects
selected to participate in the trial have back and/or leg pain, have been evaluated
as a candidate for SCS and have agreed to undergo a temporary SCS trial using
the Algovita® system with percutaneous leads. Each subject will be followed
during the trial period of approximately 7+/-2 days. 
The study will end when the last subject has completed the trial period and 
exited. The expected enrollment period for this study is approximately six
months. After exit from the clinical study, subjects will continue to be followed
by their physician per usual care. All device and procedure-related AEs will be
collected and reported per the study protocol. 
Primary 
Effectiveness 
Objective 
Compare the change in the patient defined pain coverage map from baseline to
the end of the 7+/-2 day trial. 
Secondary 
Effectiveness 
Objectives 
Secondary measures of therapy effectiveness will include: 
• 
Compare the change from baseline of pain scores between the two study
arms. Pain scores are obtained using the Numeric Rating Score (NRS)
administered at baseline and after completion of each arm of the study. 
• 
Paresthesia distribution: At end of each arm, subjects will be asked to
complete a diagram that shows distribution of paresthesia. 
• 
At the end of the trial period, subjects will be asked to select their favorite
program. 
• 
At the end of the trial period, subjects will be asked to rate the quality of 
the pain relief achieved during the trial (from either arm) using the 
following scale; Excellent, Very Good, Good, Fair or Poor. 
• 
At the end of the trial period, subjects will be asked to rate their overall
satisfaction with the pain relief achieved during the trial (from either arm)
using the following scale: Very Satisfied, Satisfied, Neither Satisfied nor
Unsatisfied, Unsatisfied, or Very Unsatisfied. 
Secondary 
Safety 
Objectives 
Secondary measures of therapy safety will include: 
• Rate of device-related and/or procedure-related AEs from the Trial
procedure through study completion. 

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iii 
Study Procedures 
After the subject has consented to the study, he or she will be enrolled in the
clinical study and undergo a baseline evaluation. The patient will then be 
randomly assigned to arm one (pulse with <500 µsec) or arm two (pulse width
>1000 µsec) and undergo an Algovita® trial procedures. Following the trial 
procedure, the subject’s EPG will be set to the appropriate pulse width, based on 
the arm assigned, and then programmed to achieve optimal pain relief. For the
next three days, the subject will evaluate pain relief generated by the 1st assigned
program (arms). 
After 3 days, the patient will visit the Ohio Pain Clinic for data collection and
then reprogramming of the EPG for the next arm. For the next three days, the
subject will evaluate the SCS therapy generated by the 2nd assigned program and 
then return to the clinic for data collection, removal of the leads and exit from 
the study. After the subject is exited from the study, he or she will be followed
by the Ohio Pain Clinic per usual care. The data collection requirements are 
listed below. 
Enrollment: 
• Informed consent signed 
• Confirmation of study eligibility 
Baseline evaluation: 
• Record pain ratings and pain map 
• Relevant medical history  
• Physical examination 
• Brief Pain Inventory 
• Demographics 
After the lead implantation: 
• Implant procedure 
• Document SCS products & lead configuration, electrode position and 
programmed parameters  
4 and 7 day (+/– 2) Post-Implantation:  
• Record pain map data 
• Record pain rating for current arm 
• Record paresthesia and pain map for current arm 
• Document AEs 
• Program subject with next arm parameters and document 
Study Exit  
• Record pain map data 
• Record pain rating for current arm 
• Record paresthesia and pain map for current arm 
• Record program preference  
• Record satisfaction and pain relief from each program 
• Document study exit reason & AEs 

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iv 
 
TIME AND EVENTS SCHEDULE 
 
Assessments and Data Collection 
Enrollment 
Baseline 
After Implant 
Follow-up 
Visits 
Study Exit 
• 
Eligibility confirmation 
✓ 
 
 
 
 
• 
Medical history 
• 
Physical exam 
✓ 
 
 
 
 
• 
Informed consent 
✓ 
 
 
 
 
• 
Record demographics 
• 
Brief Pain Inventory 
• 
Record pain map 
 
✓ 
✓ 
✓
 
 
 
• 
Implant and system information 
 
 
✓ 
 
 
• 
Record paresthesia and pain map for 
current arm 
• 
Record pain rating for current arm 
• 
Document any AEs 
 
 
✓ 
✓ 
 
 
✓ 
✓ 
✓ 
 
✓ 
✓ 
✓ 
 
✓ 
✓ 
✓ 
 
✓ 
✓ 
• 
Record subject program preference  
• 
Record subject satisfaction and pain 
relief from each program 
• 
Document study exit reason & any 
AEs 
 
 
 
 
✓ 
✓ 
 
✓ 
 
FLOWCHART 
 
PROTOCOL HISTORY OF CHANGE 
TBD 
Original issue 
 
 

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v 
Table of Contents 
 
Page 
Protocol Title ..................................................................................................................................... i 
Protocol Synopsis ............................................................................................................................. ii 
Protocol History of Change/ Summary of Bibliography Studies .................................................... vi 
List of Abbreviations and Definitions ...............................................................................................x 
1.0 
INTRODUCTION ..............................................................................................................8 
2.0 
OBJECTIVES ................................................................................................................... 10 
2.1 
Primary Objective ............................................................................................... 10 
2.2 
Secondary Objectives ......................................................................................... 10 
3.0 
REGULATORY CLASSIFICATION .............................................................................. 11 
4.0 
DEVICE ............................................................................................................................ 11 
4.1 
ALGOVITA® SPINAL CORD STIMULATION SYSTEM ............................. 11 
5.0 
STUDY DESIGN .............................................................................................................. 12 
5.1 
OVERVIEW OF DATA COLLECTION AT STUDY VISITS ......................... 12 
6.0 
ENDPOINTS .................................................................................................................... 13 
6.1 
PRIMARY EFFECTIVENESS ENDPOINT...................................................... 13 
6.2 
SECONDARY ENDPOINTS ............................................................................. 13 
7.0 
MINIMIZATION OF BIAS .............................................................................................. 14 
8.0 
INVESTIGATORS ........................................................................................................... 15 
8.1 
INVESTIGATOR SELECTION AND RESPONSIBILITIES ........................... 15 
9.0 
STUDY POPULATION ................................................................................................... 16 
9.1 
Inclusion Criteria ................................................................................................ 16 
9.2 
Exclusion Criteria ............................................................................................... 16 
9.3 
Sample Size ........................................................................................................ 16 
10.0 
Methods and Procedure ..................................................................................................... 17 
10.1 
DATA COLLECTION REQUIREMENTS........................................................ 17 
10.1.1 
Subject Screening Procedure ................................................................ 17 
10.1.2 
Informed Consent ................................................................................. 17 
10.1.3 
BASELINE VISIT ............................................................................... 18 
10.1.4 
IMPLANT ............................................................................................ 18 
10.1.5 
FOLLOW-UP VISITS.......................................................................... 18 
10.1.6 
STUDY EXIT ....................................................................................... 18 
11.0 
ADVERSE EVENT REPORTING ................................................................................... 20 
11.1 
ADVERSE EVENTS .......................................................................................... 20 
11.2 
ANTICIPATED ADVERSE DEVICE EFFECTS ............................................. 20 
11.3 
UNANTICIPATED ADVERSE DEVICE EFFECTS ........................................ 21 
12.0 
STATISTICS .................................................................................................................... 22 
12.1 
Study Population ................................................................................................. 22 
12.2 
Safety Analysis ................................................................................................... 22 
13.0 
ETHICS ............................................................................................................................ 23 
13.1 
Medical Ethics Committee ( IRB ) Review ........................................................ 23 
13.2 
Ethical Conduct of the Study .............................................................................. 23 
13.3 
Patient Information and Consent ........................................................................ 23 

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14.0 
STUDY ADMINISTRATION .......................................................................................... 24 
14.1 
Study Initiation ................................................................................................... 24 
14.2 
Clinical Supplies ................................................................................................. 24 
14.3 
Case Report Forms (CRFs) ................................................................................. 24 
14.4 
Study Completion ............................................................................................... 25 
14.5 
Final Report ........................................................................................................ 25 
14.6 
Retention of Study Records ................................................................................ 25 
14.7 
Confidentiality .................................................................................................... 25 
14.8 
Publication of Study Results ............................................................................... 26 
15.0 
SIGNATURE of PRINCIPAL INVESTIGATOR ............................................................ 27 
16.0 
Declaration of Helsinki ..................................................................................................... 28 
17.0 
REFERENCES BIBLIOGRAPHY ................................................................................... 31 

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vii 
List of Abbreviations and Definitions 
 
Abbreviation/Term 
Definition 
ADE: 
 Adverse Device Event 
AE:  
Adverse Event 
CIP:  
Clinical Investigational Plan  
CRF:  
Case Report Form 
CTA:  
Clinical Trial Agreement 
FDA:  
Food and Drug Administration  
GCP:   
Good Clinical Practices 
ICF:   
Informed Consent Form 
ICH:   
International Conference on Harmonization 
IRB:  
Institutional Review Board 
ISO:   
International Organization for Standardization 
NRS:  
Numeric Rating Scale 
PW:  
Pulse Width 
SADE:  
Serious Adverse Device Effect 
SCS:  
Spinal Cord Stimulation 
SOC:  
Standard of Care 
UADE:  
Unanticipated Adverse Device Effect 
USADE:  Unanticipated Serious Adverse Device Effect 
µsec:  
Micro Second 
VAS: 
Visual Analog Scale 
 
 
 
 
 
 
 

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8 
1.0 INTRODUCTION 
Patients with chronic intractable pain of the trunk and/or limbs are typically treated on a continuum 
with less invasive therapies prescribed first. Established, non-surgical treatment options include, 
but are not limited to, oral medications, physical therapy, TENS, acupuncture, nerve blocks, 
radiofrequency ablation and other options based on clinical judgment. The surgical treatment 
options for these patients include surgery of the spine, sympathectomy, intrathecal drug pumps, 
and spinal cord stimulation (SCS) systemsi. 
 
An advantage of a SCS system is that it is a reversible and nondestructive treatment option. The 
main principle of SCS therapy is pain suppression via the delivery of electrical signals to the spinal 
cord and related nerves through electrodes in the epidural space. An implantable pulse generator 
(IPG) is implanted under the skin, typically in the abdomen or buttock area, to generate mild 
electrical signals. The electrical signals typically produce paresthesia overlapping the area of pain 
for the patient. The IPG is programmed to deliver the electrical signals in a therapeutic manner and 
is then activated by the patient as needed to assist in management of their pain. SCS therapy 
treatment is deemed successful if there is a 50% reduction in pain as measured by a numeric rating 
scale or visual analog scale. The most common use of SCS therapy is for failed back surgery 
syndrome (FBSS) that affects up to 40% of patients who undergo spinal surgeriesii iii iv v. 
 
A candidate for SCS therapy is first tested by undergoing a trial procedure in which a temporary 
lead is implanted in the epidural space and then externalized and connected to eternal pulse 
generator (EPG). A temporary trial typically last 5 to 10 days and will allow the patient and doctor 
to determine the effectiveness of the therapy before undergoing a permanent implant. 
 
 
SCS therapy has been in use since the early 1970s and has been implanted in over 600,000 patients 
to treat chronic pain. Over the past 30 years, SCS system technology has advanced from single 
channel IPGs with single contact leads to multi- channel IPGs with over 32 channels, rechargeable 
batteries, and lead designs improved for reliability and stability. Though the principles of operation 
of the SCS system have essentially remained the same, these advances have increased safety, 
efficacy and longevity of the therapy. 
 
The Algovita® SCS System is similar in design and performance to newer SCS systems from other 
medical device companies. The FDA approved Algovita® system has many advanced features 
including the ability to better control the shape of the electrical pulse. One such feature is a longer 
pulse width range than the other systems on the market. Pulse width determines how long an 
electrical pulse is activated. A longer pulse width is not associated with any safety concerns as 
determined by the FDA. The intent and justification for this study is to understand if a longer pulse 
width provides better outcomes to patients.  
 
Although the effects of pulse width are mentioned in many SCS investigations, it has been the 
primary focus of very few studies. Several decades ago, research was conducted into the technical 
aspects of SCS, including PW. In a study of SCS, Jobling showed that different patients required 
widely varying amplitudes of stimulation and concluded that 200 μsec was the optimum pulse 
duration, because it was the most energy- efficientvi. In 1980, Davis and Gray concurred that 200 
μsec was the preferred PW to deliver adequate amplitude while conserving energyvii. Some 
published reports suggested that there was therapeutic value to having higher parameter ranges than 
were available on previous primary cell IPGs. In addition, longer PWs have been anecdotally 
described as achieving better pain-paresthesia overlap and comfort for the patient, thus potentially 
more effective at relieving painviii.  

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The introduction and widespread adoption of rechargeable IPGs for SCS has diminished the 
importance of energy efficient programming to prolong time between revision surgeries and 
resulted in longer pulse width settings in these systems. Gould and Bradley reported in a 
retrospective analysis of patient-preferred programs that over 50% of the programs used PWs in 
excess of 450 μsix. Yearwood et al. showed that 10/19 patients had greater coverage, and 8/19 
patients displayed “caudal shift” of paresthesia coverage with increased PWx. A mathematical 
model of electrical field and neural activation in SCS has shown good agreement with clinical data 
that a longer PW is associated with increased paresthesia coverage and a shift of the paresthesia 
coverage caudallyxi. 
 
Investigation into the clinical and technical effects of PWs may be important in the continued effort 
to more fully understand the mechanisms of SCS. In other neurostimulation applications, varied 
PW has been shown to provide large and small fiber neural selectivity, where shorter PWs 
maximized the difference between large and small fiber thresholdsxii. With advances in SCS 
technology, particularly rechargeable IPGs, patients are now being offered a wider range of 
parameters to treat their pain. In particular, PW programming ranges of the Algovita® system can 
be programmed up to 1500 μsec).  
 

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10 
2.0 OBJECTIVES 
2.1 
Primary Objective 
To evaluate the effect of conventional pulse widths <500 µsec and pulse widths >1000 µsec on 
clinical outcomes during temporary trial as measured by patient defined pain maps. 
 
2.2 
Secondary Objectives 
Secondary measures of therapy effectiveness will include: 
1. 
To evaluate the effect of conventional pulse widths <500µsecand pulse widths 
>1000µsecon clinical outcomes during temporary trial as measured by the percent 
reduction in targeted pain compared to baseline using the NRS at the end of the trial 
period. 
2. 
At end of each arm, subjects will be asked to complete a diagram that shows distribution 
of paresthesia. 
3. 
At the end of the trial period, subjects will be asked to select their favorite program. 
4. 
At the end of the trial period, subjects will be asked to rate the quality of the pain relief 
achieved during the trial (from either arm) using the following scale; Excellent, Very 
Good, Good, Fair or Poor  
5. 
At the end of the trial period, subjects will be asked to rate their overall satisfaction with 
the pain relief achieved during the trial (from either arm) using the following scale; Very 
Satisfied, Satisfied, Neither Satisfied nor Unsatisfied, Unsatisfied or Very Unsatisfied 
6. 
Number of patients who achieved ≥ 50% pain relief during the trial (from either arm) 
7. 
Rate of device-related and/or procedure-related AEs from SCS implant through study 
completion or study exit. 
 

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11 
3.0 DEVICE 
 
3.1 
ALGOVITA® SPINAL CORD STIMULATION SYSTEM 
This Clinical Study will include commercially released system components from 
the Algovita® SCS System manufactured by Nuvectra® Corporation (Plano, 
Texas). The materials, dimensions, method of construction, indications for use, 
and principles of operation of the Algovita® SCS system components are the same 
or functionally similar to the FDA-approved and CE marked products distributed 
by Medtronic, Abbott (St. Jude), and Boston Scientific. 
 
The Algovita® SCS system is indicated as an aid in the management of chronic 
intractable pain of the trunk and/or limbs, including unilateral or bilateral pain 
associated with failed back surgery syndrome, intractable low back pain and leg 
pain. 
 
The devices used for this study will be sourced through normal commercial 
channels from Nuvectra® and will not be supplied by the Sponsor. 
 
3.2 
REGULATORY CLASSIFICATION 
The Algovita® SCS System received CE Mark in Europe on 14 June 2014 and 
FDA (PMA) approval in the US on 20 November 2015. 
 
The sponsor has determined that this qualifies as a post-market study. The SCS 
system is being used per labeling indications and data collection have been aligned 
with typical data collection for SCS systems. 
 
 
 

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12 
4.0 STUDY DESIGN 
The proposed study is a prospective, single-center, two arm, randomized, 
crossover design to be conducted at The Ohio Pain Clinic. The study will enroll 
up to 100 subjects in order to assure at least 50 subjects in the study. Subjects 
selected to participate in the trial have back and/or leg pain, have been identified 
as a candidate for SCS and have agreed to undergo a temporary SCS trial using 
the Algovita® system with percutaneous leads. Each subject will be followed 
during the trial period of approximately 7 days. 
 
The study will end when the last subject has completed the trial period or is exited. 
The expected enrollment period for this study is approximately three months. After 
exit from the clinical study, subjects will continue to be followed by their physician 
per usual care. All device and procedure-related AEs will be collected and reported 
per the study protocol. 
4.1 
OVERVIEW OF DATA COLLECTION AT STUDY 
VISITS 
Assessments and Data Collection 
Enrollment 
Baseline 
After Implant 
Follow-up 
Visits 
Study Exit 
• 
Eligibility confirmation 
✓ 
 
 
 
 
• 
Medical history 
• 
Physical exam 
✓ 
 
 
 
 
• 
Informed consent 
✓ 
 
 
 
 
• 
Record demographics 
• 
Brief Pain Inventory 
• 
Record pain map 
 
✓ 
✓ 
✓
 
 
 
• 
Implant and system information 
 
 
✓ 
 
 
• 
Record paresthesia and pain map for 
current arm 
• 
Record pain rating for current arm 
• 
Document any AEs 
 
 
✓ 
✓ 
 
 
✓ 
✓ 
✓ 
 
✓ 
✓
✓ 
 
✓ 
✓
✓ 
 
✓ 
✓
• 
Record subject program preference  
• 
Record subject satisfaction and pain 
relief from each program 
• 
Document study exit reason & any 
AEs 
 
 
 
 
✓ 
✓ 
 
✓ 
    Figure 4.1 Study Flowchart 

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13 
5.0 ENDPOINTS 
The endpoints of the study are focused on collecting data to determine clinical 
outcomes of Pulse Widths >1000µseccompared to Pulse Widths <500µsecduring 
an SCS trial. Safety data will also be collected at all visits. Data will be collected 
using: 
• 
Patient generated Pain Maps 
• 
The NRS to assess pain levels 
• 
Questionnaires to assess pain coverage, program preference, overall 
satisfaction of the trial and AEs 
 
5.1 
PRIMARY EFFECTIVENESS ENDPOINT 
The primary effectiveness endpoint is defined as the percent reduction from 
baseline in targeted patient generated pain map coverage between the two arms. 
 
5.2 
SECONDARY ENDPOINTS 
Endpoints for secondary measures of therapy effectiveness: 
• To evaluate the effect of conventional pulse widths and pulse widths 
>1000µsecon clinical outcomes during temporary trial as measured by the 
percent reduction in targeted pain compared to baseline using the NRS at 
the end of the trial period. 
• Comparison of paresthesia overlap of pain between each arm as evaluated 
by the reviewer to determine which arm had superior pain overlap 
(coverage) 
• Patient preference for pulse widths >1000µsecor <500 µS 
• Patient satisfaction for pulse widths >1000µsecor <500 µS 
• Number of patients who achieved ≥ 50% pain relief during the trial (from 
either arm) 
• Rate of device-related and/or procedure-related AEs from Trial Lead 
implant through study completion. 
 

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14 
6.0 MINIMIZATION OF BIAS 
Potential sources of bias in this study may result from selection of subjects, 
treatment of subjects, and evaluation of study data. The following methods have 
been incorporated into the study to minimize potential bias. 
• 
Subjects will be screened to confirm eligibility for enrollment with defined 
inclusion/exclusion criteria prior to enrollment 
• 
Subject demographics will be collected at baseline on possible differences 
that may affect the primary objective 
• 
All study clinicians, participating site personnel, and the Sponsor’s 
personnel will be trained on their respective aspects of the study using 
standardized training materials 
• 
All study clinicians will be trained on and required to follow the CIP 

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15 
7.0 INVESTIGATORS 
7.1 INVESTIGATOR SELECTION AND RESPONSIBILITIES 
In order for the Investigators to participate in the study, they must meet the 
following criteria: 
• Curriculum vitae (CV) providing evidence of sufficient training and 
experience in the management of patients with chronic pain. 
• Has implanted and managed at least 12 patients with SCS devices within 
the past 12 months. 
• The Investigator’s participation in other clinical studies will not present a 
conflict of interest and will not interfere with the clinical study enrollment, 
study management, or study confidentiality. 
• Is willing to provide any conflicts of interest details. 
• Is willing to comply with all federal laws and regulations as well as IRB 
rules regarding clinical studies. 
 

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16 
8.0 STUDY POPULATION  
Subjects that are candidates for SCS, agreed to undergo an SCS temporary trial and 
that meet study eligibility criteria will be asked to participate in the study and will 
be required to sign informed consent prior to any study-related procedures or data 
collection occurring. It is expected that up to 15 subjects may be enrolled to screen 
for eligibility, and up to 10 subjects will undergo an SCS trial with the Algovita® 
Trial System. Subjects may either be male or female and must meet all eligibility 
criteria noted below which are typical eligibility criteria for SCS system post-
market studies.  
 
8.1 
Inclusion Criteria 
To be eligible for this study, patients MUST: 
1. be eligible for SCS therapy according to the Algovita® SCS system 
Indications for Use statement 
2. be undergoing a SCS trial using Algovita® SCS system 
3. sign a valid, Institutional Review Board (IRB)-approved informed consent 
form. 
4. be 18 years of age or older when written informed consent is obtained 
 
8.2 
Exclusion Criteria 
To be eligible for enrollment in this study, the patients must NOT: 
 
1. be contraindicated for an Algovita® SCS system 
2. have a cognitive impairment or exhibits any characteristic, that would limit 
the study candidate's ability to assess pain relief or complete study 
assessments 
3. have a life expectancy of less than 2 years 
4. be participating in another clinical study that would confound data analysis 
5. have a coexisting pain condition that might confound pain ratings 
6. have a significant psychiatric disorder 
 
8.3 
Sample Size  
The study sample size is limited to 100 subjects. 
 

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17 
9.0 Methods and Procedure 
 
9.1 
DATA COLLECTION REQUIREMENTS 
Subject data will be collected and documented on case report forms (CRFs). 
Drafts of the CRFs for this study are located in Appendix 17. 
 
9.1.1 
Subject Screening Procedure 
Subjects will be screened from candidates for SCS, that have agreed to 
undergo an SCS temporary trial and that meet study eligibility. Subjects 
who meet these criteria will be asked to participate in the study and if they 
agree will be required to sign an informed consent prior to any study-
related procedures or data collection occurring. 
Assessments and Data Collection 
Enrollment 
Baseline 
After Implant 
Follow-up Visits 
Study Exit 
• 
Eligibility 
✓ 
 
 
 
 
• Medical history 
• Physical exam 
✓ 
 
 
 
 
• Informed consent 
✓ 
 
 
 
 
• Record demographics 
• Brief Pain Inventory 
• Record pain map 
 
✓ 
✓ 
✓ 
 
 
 
✓ 
 
 
✓ 
• Implant and system information 
 
 
✓ 
 
 
• Record pain rating for current arm 
• Record paresthesia and pain map for 
current arm 
• Document any AEs 
 
 
 
 
 
✓ 
✓ 
✓ 
• Record subject program preference  
• Record subject satisfaction and pain 
relief from each program 
• Document study exit reason & any 
 
 
 
 
✓ 
✓ 
 
✓
Table 6-1: Summary of assessments at each visit 
 
9.1.2 
Informed Consent 
Informed consent is defined as legally effective, documented 
confirmation of a subject’s (or their legally authorized representative or 
guardian) voluntary agreement to participate in a particular clinical 

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18 
investigation after information has been given to the subject on all aspects 
of the clinical investigation that are relevant to the subject’s decision to 
participate. When a subject signs and dates the informed consent form, 
he/she is considered a subject enrolled in the study. 
Prior to initiation of any study-specific procedures, subjects (or their 
legally authorized representative or guardian) must sign and date the 
informed consent form and Health Insurance Portability and 
Accountability Act (HIPAA) authorization, or equivalent, where required 
by law and IRB. Documentation that consent was obtained prior to any 
study-related procedures must be maintained in the subject’s case history.  
 
9.1.3 
BASELINE VISIT 
Confirm subject’s eligibility for study participation and perform a Baseline visit. 
The following data will be collected by the study physician during this 
assessment and documented as appropriate: 
• 
Relevant medical history (including diagnosis, prior treatment for chronic 
pain, past surgical procedures) 
• 
Demographics 
• 
Physical examination  
• 
Collection of Brief Pain Inventory, pain-related ratings (NRS) and pain map 
 
9.1.4 
IMPLANT  
The implant trial procedure will be performed within 28 calendar days following 
the Baseline Visit. Appropriately trained field staff will assist as necessary with 
the Algovita® Trial Lead implant. The recommended placement for the device 
will be determined by the physician and documented on the CRF. Information 
regarding the devices used, location, and procedure data will be collected on an 
Implant CRF. A Nuvectra® representative may be present during the implant 
procedure and may assist in the programming of the Algovita® system at the 
Investigator’s direction. 
 
9.1.5 
FOLLOW-UP VISITS 
Follow-up visits will occur at day 4 and 7 (+/–2) post-implantation. Data 
collected at these visits will be recorded on case forms (CRFs) and will include: 
• 
Record paresthesia and pain map for current arm  
• 
Record pain rating for current arm 
• 
Document AEs 
• 
Program subject with next arm parameters and document 
9.1.6 
STUDY EXIT 
A Study Exit CRF must be completed for any subject who signed an informed 
consent form, as they are considered enrolled in the study. Data to be collected 
at this visit includes: 
• 
Record paresthesia and pain map for current arm 
• 
Record pain rating for current arm 
• 
Record program preference  

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19 
• 
Record satisfaction and pain relief from each program 
• 
Study exit date and reason for study exit 
Additional data that will be collected as they occur include: 
• 
Device or procedure related AEs 
• 
Technical Observations/Device Deficiencies 
• 
Surgical Interventions 
The following scenarios may lead to study exit and will require completion of a 
Study Exit CRF. 
• 
Inclusion/exclusion criteria not met 
• 
Subject ineligibility for implant, in the opinion of the study physician 
• 
SCS lead removal without re-implantation 
• 
Implant attempted, however no SCS was implanted 
• 
Voluntary withdrawal by subject 
• 
Investigator chooses to withdraw a subject 
• 
Failure to maintain adequate study compliance 
• 
Subject Death 
 
 

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10.0 ADVERSE EVENT REPORTING 
10.1 ADVERSE EVENTS 
At each evaluation, the investigator will determine whether any adverse events 
(AE’s) have occurred.  For the purpose of this protocol, an adverse event is any 
undesirable clinical occurrence in a subject that can be attributed to the device or 
incision closure procedure. 
 
In this study, patients should be encouraged to report AE’s spontaneously or in 
response to general, non-directed questioning (e.g., “How has your health been 
since the last visit?”).  Any time during the study, the patient may volunteer 
information that resembles an AE.  If it is determined that an AE has occurred, the 
investigator should obtain all the information required to complete the AE Form of 
the CRF. 
 
The following categories of adverse event severity are to be used: 
Mild 
Awareness of a sign or symptom that does not interfere with the 
patient's usual activity or is transient, resolved without treatment and
with no sequelae 
Moderate 
Interferes with the patient's usual activity 
Severe 
Any fatal or immediately life-threatening clinical experience that 
requires a subject to be hospitalized, or hospitalization is unduly
prolonged because of potential disability or danger to life or because 
an intervention has been necessitated.  This includes events that cause 
fetal distress, fetal death, congenital abnormality or malignancy or 
any permanently disabling event. 
 
10.2 ANTICIPATED ADVERSE DEVICE EFFECTS 
The following ANTICIPATED EVENTS have been identified as possible 
complications of implanting neurostimulator leads. 
• 
Infection at implant site 
• 
Pain at implant site 
• 
Bleeding 
• 
Bruising 
• 
Device failure 
o Unintended stimulation 
o Increased stimulation 
o Decreased stimulation 
o Lead breakage/migration 
o Battery depletion 
o Erosion of device 
o General device failure 
 

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10.3 UNANTICIPATED ADVERSE DEVICE EFFECTS 
Unanticipated adverse device effects are defined as any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated 
with, a device, if that effect, problem, or death was not previously identified in 
nature, severity or degree of incidence in the investigational plan or application 
(including a supplementary plan or application), or any other unanticipated serious 
problem associated with a device that relates to the rights, safety or welfare of 
subjects. 
For the purposes of this study, serious is defined as any significant adverse 
experience, including those which may be either life-threatening or involve 
permanent or long term injuries, but excluding injuries that are non-life-threatening 
and that are temporary and reasonably reversible. 
An Investigator must submit to the sponsor and to the responsible Medical 
Ethics Committee ( IRB ) any unanticipated adverse device effects occurring 
during the study as soon as possible, but in no event later than ten (10) working 
days after the Investigator first learns of the effect. 
Contact Name: 
Erin Dewenter, RN  
 
 
 
 
                    
Ohio Pain Clinic  
7076 Corporate Way 
Dayton, OH 45458 
 
Report 
Submit To 
Description/Constraints 
Death 
Sponsor 
Submit as soon as possible but no later than 10 working 
days after the Investigator first learns of the event. 
IRB 
Submit to IRB per local reporting requirements. 
Unanticipated 
adverse device effect 
(UADE)1 
Sponsor 
Submit as soon as possible but no later than 10 working 
days after the Investigator first learns of the event. 
IRB 
Submit as soon as possible but no later than 10 working 
days after the Investigator first learns of the event, or per 
local reporting requirements, whichever is more 
conservative. 
Other Adverse Device 
Effects 
Sponsor 
Submit or report as required per local reporting 
requirements. 
IRB 
Submit or report as required per local IRB reporting 
requirements. 
Regulatory Body 
Submit or report as required per regulations. 
Table 11-1: Investigator adverse event reports 

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11.0 STATISTICS 
11.1 Study Population 
All patients who received treatment will be included in an intent-to-treat (ITT) 
analysis.  A per protocol analysis will also be conducted if there are protocol 
violators. 
11.2 Safety Analysis 
All patients who received treatment will be included in the safety analysis.  The 
proportion of patients with complications will be compared by Fisher’s Exact test. 
The two treatment groups will be compared using t-test for continuous variables 
and chi square test for category variables. All adverse events will be listed and the 
frequencies, severity, and relationship to the treatment procedure will be tabulated 
and compared by treatment groups.  

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12.0 ETHICS 
12.1 Medical Ethics Committee ( IRB ) Review 
Prior to initiation of the study, the Principal Investigator will submit the study 
protocol, sample Informed Consent Form, and any other documents that may be 
requested, to the IRB for review and approval.  The Principal Investigator and will 
request that the IRB provide written approval of the study and will keep on file all 
IRB correspondence including records of approval of all documents pertaining to 
this study.  If the IRB imposes any additional requirements (e.g. safety reports, 
progress reports etc.), the Sponsor will prepare the required documents and send 
them to the Investigator for reporting to the IRB. 
12.2 Ethical Conduct of the Study 
This study will be conducted in compliance with the protocol, good clinical 
practices (GCP), and the applicable regulatory requirements. 
12.3 Patient Information and Consent 
Prior to screening for the study, each patient, as required, will be informed in detail 
about the nature of the clinical investigation with its expected risks and discomforts.  
The basic elements of informed consent as specified by the EU Directive 
2001/20/EC will be followed.  Written consent will be obtained from each patient 
as required, to be involved in the clinical study by using the  IRB -approved 
Informed Consent Form.  The Principal Investigator will verify the consent form.  
Each patient will be given a copy of the Informed Consent Form.  The patients will 
also be instructed that they are free to withdraw their consent and discontinue their 
participation in the study at any time without prejudice.  Prior to the start of the 
study, the Principal Investigator will provide    with an actual Informed Consent 
Form approved by the  IRB  for use during the study.  At the conclusion of the 
study, the Principal Investigator will provide a letter to stating that a signed 
informed consent was obtained from each of the study patients.  The signed 
informed consent forms will be kept on file at the study site for the required period 
of time. 

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13.0 STUDY ADMINISTRATION 
13.1 Study Initiation 
Prior to the start of this study, all pre-investigational requirements must be met by the 
Principal Investigator and study site.  Compliance will be confirmed by the study monitor 
during the pre-study visit.  The pre-investigational requirements may include: 
1. 
Current Curricula Vitae and current medical licenses or medical numbers of the Principal 
Investigator and all sub-investigators 
2. 
 IRB  name and address; Department of Health and Human Services (DHHS) number, if 
applicable, or membership list 
3. 
Written documentation of  IRB  approval of protocol (identified by protocol number and 
title) and informed consent document (identified by protocol number and title) 
4. 
A copy of the  IRB  approved consent form (that has also been approved by   ) 
5. 
A signed Clinical Research Agreement 
• 
Provisions for direct access to source/data documents if necessary for study-related 
monitoring, audits,  IRB  review, and regulatory inspection. 
13.2 Clinical Supplies 
The Principal Investigator will be responsible for the dispensing, inventory, and 
accountability of all clinical supplies, exercising accepted medical practices.  An accurate 
and timely record of the disposition of all clinical supplies must be maintained.  The 
supplies and inventory record must be made available for inspection by the Clinical 
Monitor and    upon request.  Upon completion or termination of the study the Principal 
Investigator will return all remaining clinical supplies to   , or designee along with a copy 
of the inventory record and a record of the clinical supplies returned.  Under no 
circumstances will the Principal Investigator allow the investigational device to be used 
other than as directed by this protocol.  
13.3 Case Report Forms (CRFs) 
   will provide the CRFs.  The Principal Investigator will be responsible for the timeliness, 
completeness, and accuracy of the information on the CRF.  All entries must be legibly 
recorded in ink, with entry errors designated by a single-line cross out, initialed and dated, 
such that the original entry remains readable 
The Principal Investigator will make these forms available for review and collection by the 
designated representative at each scheduled monitoring visit. 
The Principal Investigator will retain a file copy of each completed CRF.  In addition, the 
Principal Investigator will ensure that the monitor representative(s) have access to source 

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documents (e.g., hospital and clinic records) to ensure accuracy and completeness of the 
CRFs during the periodic reviews. 
13.4 Study Completion 
Data and materials that are required before the study can be considered complete and/or 
terminated are: 
• 
Laboratory findings, clinical data, and all special test results from treatment through 
the end of the follow-up period 
• 
CRFs (including correction forms) properly completed by appropriate study personnel 
and signed by the Principal Investigator 
• 
Completed Device Accountability Records 
• 
Statement of outcome for each unanticipated adverse device effect reported 
• 
Copies of protocol amendments and IRB  approvals (if applicable) 
13.5 Final Report 
The purpose of this single center pilot study is to assess the clinical performance of    
Wireless stimulator device when used to treat UUI. The results will be presented in a 
clinical report presented by    with the study data provided by the Primary Investigator (PI).   
13.6 Retention of Study Records   
The Principal Investigator will retain copies of the approved protocol, completed CRFs, 
informed consent documents, relevant source documents, study-related correspondence 
and all other supporting documentation related to the project for the latter of a period of 2 
years following the approval of a premarket application (U.S.) or 2 years from the time the 
study is terminated.  
These files must be made available for inspection upon reasonable request by authorized 
representatives of the Ohio Pain Clinic. 
 
13.7 Confidentiality 
Patient medical information obtained by the study is confidential and disclosure to third 
parties other than those noted below is prohibited. 
At the patient's request, medical information may be given to his or her personal physician 
or other appropriate medical personnel responsible for his or her welfare. 
Data generated by this study must be available for inspection on request by representatives 
of Nuvectra, and the IRB s (if appropriate).   
The information obtained in this study may be published in medical journals, but will not 
reveal the identity of the individual patients. 

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13.8 Publication of Study Results 
Results of this study will not be submitted for presentation or publication without the prior 
written permission of   . 

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14.0 SIGNATURE of PRINCIPAL INVESTIGATOR 
I have read the    study protocol, entitled Single center pilot study to show efficacy of a 
neurostimulator for the treatment of refractive UUI.  I agree to conduct the investigation in 
accordance with the agreement, the investigational plan and applicable EU and US 
regulations.  Further, I agree to conduct the investigation in accordance with the conditions 
imposed by the reviewing  IRB /IRB.  This includes the supervision of the device involving 
human patients and ensuring that the requirements for obtaining informed consent are met. 
 
 
 
 
Principal Investigator   
 
 
 
 
 
Date 
 
 

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15.0 Declaration of Helsinki 
 
WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI 
 Ethical Principles for Medical Research Involving Human Subjects  
 
Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the 
29th WMA General Assembly, Tokyo, Japan, October 1975 
35th WMA General Assembly, Venice, Italy, October 1983 
41st WMA General Assembly, Hong Kong, September 1989 
48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 
and the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000  
  
1. 
INTRODUCTION  
1. 
The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles 
to provide guidance to physicians and other participants in medical research involving human subjects. Medical 
research involving human subjects includes research on identifiable human material or identifiable data. 
2. 
It is the duty of the physician to promote and safeguard the health of the people. The physician's knowledge and 
conscience are dedicated to the fulfillment of this duty. 
3. 
The Declaration of Geneva of the World Medical Association binds the physician with the words, "The health 
of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A 
physician shall act only in the patient's interest when providing medical care which might have the effect of 
weakening the physical and mental condition of the patient."  
4. 
Medical progress is based on research which ultimately must rest in part on experimentation involving human 
subjects. 
5. 
In medical research on human subjects, considerations related to the well-being of the human subject should take 
precedence over the interests of science and society. 
6. 
The primary purpose of medical research involving human subjects is to improve prophylactic, diagnostic and 
therapeutic procedures and the understanding of the aetiology and pathogenesis of disease. Even the best proven 
prophylactic, diagnostic, and therapeutic methods must continuously be challenged through research for their 
effectiveness, efficiency, accessibility and quality.  
7. 
In current medical practice and in medical research, most prophylactic, diagnostic and therapeutic procedures 
involve risks and burdens.  
8. 
Medical research is subject to ethical standards that promote respect for all human beings and protect their health 
and rights. Some research populations are vulnerable and need special protection. The particular needs of the 
economically and medically disadvantaged must be recognized. Special attention is also required for those who 
cannot give or refuse consent for themselves, for those who may be subject to giving consent under duress, for 
those who will not benefit personally from the research and for those for whom the research is combined with 
care.  
9. 
Research Investigators should be aware of the ethical, legal and regulatory requirements for research on human 
subjects in their own countries as well as applicable international requirements. No national ethical, legal or 
regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set 
forth in this Declaration. 
2. 
BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH  

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1. 
It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of the human 
subject.  
2. 
Medical research involving human subjects must conform to generally accepted scientific principles, be based 
on a thorough knowledge of the scientific literature, other relevant sources of information, and on adequate 
laboratory and, where appropriate, animal experimentation. 
3. 
Appropriate caution must be exercised in the conduct of research which may affect the environment, and the 
welfare of animals used for research must be respected. 
4. 
The design and performance of each experimental procedure involving human subjects should be clearly 
formulated in an experimental protocol. This protocol should be submitted for consideration, comment, 
guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be 
independent of the investigator, the sponsor or any other kind of undue influence. This independent committee 
should be in conformity with the laws and regulations of the country in which the research experiment is 
performed. The committee has the right to monitor ongoing trials. The researcher has the obligation to provide 
monitoring information to the committee, especially any serious adverse events. The researcher should also 
submit to the committee, for review, information regarding funding, sponsors, institutional affiliations, other 
potential conflicts of interest and incentives for subjects.  
5. 
The research protocol should always contain a statement of the ethical considerations involved and should 
indicate that there is compliance with the principles enunciated in this Declaration.  
6. 
Medical research involving human subjects should be conducted only by scientifically qualified persons and 
under the supervision of a clinically competent medical person. The responsibility for the human subject must 
always rest with a medically qualified person and never rest on the subject of the research, even though the 
subject has given consent.  
7. 
Every medical research project involving human subjects should be preceded by careful assessment of 
predictable risks and burdens in comparison with foreseeable benefits to the subject or to others. This does not 
preclude the participation of healthy volunteers in medical research. The design of all studies should be publicly 
available. 
8. 
Physicians should abstain from engaging in research projects involving human subjects unless they are confident 
that the risks involved have been adequately assessed and can be satisfactorily managed. Physicians should cease 
any investigation if the risks are found to outweigh the potential benefits or if there is conclusive proof of positive 
and beneficial results.  
9. 
Medical research involving human subjects should only be conducted if the importance of the objective 
outweighs the inherent risks and burdens to the subject. This is especially important when the human subjects 
are healthy volunteers.  
10. 
Medical research is only justified if there is a reasonable likelihood that the populations in which the research is 
carried out stand to benefit from the results of the research.  
11. 
The subjects must be volunteers and informed participants in the research project. 
12. 
The right of research subjects to safeguard their integrity must always be respected. Every precaution should be 
taken to respect the privacy of the subject, the confidentiality of the patient's information and to minimize the 
impact of the study on the subject's physical and mental integrity and on the personality of the subject. 
13. 
In any research on human beings, each potential subject must be adequately informed of the aims, methods, 
sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated 
benefits and potential risks of the study and the discomfort it may entail. The subject should be informed of the 
right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal. 
After ensuring that the subject has understood the information, the physician should then obtain the subject's 
freely-given informed consent, preferably in writing. If the consent cannot be obtained in writing, the non-written 
consent must be formally documented and witnessed.  

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14. 
When obtaining informed consent for the research project the physician should be particularly cautious if the 
subject is in a dependent relationship with the physician or may consent under duress. In that case the informed 
consent should be obtained by a well-informed physician who is not engaged in the investigation and who is 
completely independent of this relationship.  
15. 
For a research subject who is legally incompetent, physically or mentally incapable of giving consent or is a 
legally incompetent minor, the investigator must obtain informed consent from the legally authorized 
representative in accordance with applicable law. These groups should not be included in research unless the 
research is necessary to promote the health of the population represented and this research cannot instead be 
performed on legally competent persons.  
16. 
When a subject deemed legally incompetent, such as a minor child, is able to give assent to decisions about 
participation in research, the investigator must obtain that assent in addition to the consent of the legally 
authorized representative.  
17. 
Research on individuals from whom it is not possible to obtain consent, including proxy or advance consent, 
should be done only if the physical/mental condition that prevents obtaining informed consent is a necessary 
characteristic of the research population. The specific reasons for involving research subjects with a condition 
that renders them unable to give informed consent should be stated in the experimental protocol for consideration 
and approval of the review committee. The protocol should state that consent to remain in the research should 
be obtained as soon as possible from the individual or a legally authorized surrogate. 
18. 
Both authors and publishers have ethical obligations. In publication of the results of research, the investigators 
are obliged to preserve the accuracy of the results. Negative as well as positive results should be published or 
otherwise publicly available. Sources of funding, institutional affiliations and any possible conflicts of interest 
should be declared in the publication. Reports of experimentation not in accordance with the principles laid down 
in this Declaration should not be accepted for publication.  
3. 
ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE 
1. 
The physician may combine medical research with medical care, only to the extent that the research is justified 
by its potential prophylactic, diagnostic or therapeutic value. When medical research is combined with medical 
care, additional standards apply to protect the patients who are research subjects. 
2. 
The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current 
prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in 
studies where no proven prophylactic, diagnostic or therapeutic method exists.  
3. 
At the conclusion of the study, every patient entered into the study should be assured of access to the best proven 
prophylactic, diagnostic and therapeutic methods identified by the study.  
4. 
The physician should fully inform the patient which aspects of the care are related to the research. The refusal 
of a patient to participate in a study must never interfere with the patient-physician relationship. 
5. 
In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic methods do not exist or have 
been ineffective, the physician, with informed consent from the patient, must be free to use unproven or new 
prophylactic, diagnostic and therapeutic measures, if in the physician's judgment it offers hope of saving life, re-
establishing health or alleviating suffering. Where possible, these measures should be made the object of 
research, designed to evaluate their safety and efficacy. In all cases, new information should be recorded and, 
where appropriate, published. The other relevant guidelines of this Declaration should be followed.  
 

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16.0 REFERENCES BIBLIOGRAPHY 
 
i American Chronic Pain Association Resource Guide to Chronic Pain Medication 
and Treatment, 2014 Edition.  
ii North RB. Failed back surgery syndrome: 5-year follow-up in 102 patients 
undergoing repeated operation. Neurosurgery, vol. 28, p. 685–90, 1991.  
iii Wilkinson HA. The Failed Back Surgery Syndrome: Etiology and Therapy, 2nd 
edition., Philadelphia: Harper & Row, 1991. 
iv Law JD. Reoperation after lumbar intervertebral disc surgery. J Neurosurg, vol. 
48, p. 259–63, 1978. 
v  Lehmann TR. Repeat lumbar surgery: A review of patients with failure from 
previous lumbar surgery treated by spinal canal exploration and lumbar spinal 
fusion. Spine , vol. 6, p. 615–9, 1981.  
vi Jobling DT, Tallis RC, Sedgwick EM, Illis LS. Electronic aspects of spinal-cord 
stimulation in multiple sclerosis. Med Biol Eng Comput 1980; 18:48-56 
vii Davis R, Gray E. Technical factors important to dorsal column stimulation. 
Appl Neurophysiol 1981; 44:160-170. 
viii Meyerson B. Commentary on: Holsheimer J. Effectiveness of spinal cord 
stimulation in the management of chronic pain: Analysis of technical drawbacks 
and solutions. Neurosurgery 1997; 40:990-999. 
ix Gould B, Bradley K. Pulse width programming in spinal cord stimulators. 
Abstract of the American Academy of Pain Medicine 22nd Annual Meeting, 2006 
February 22-25. San Diego, CA 
x Yearwood TL, MD, Hershey B, Bradley K, Lee D. Pulse Width Programming in 
Spinal Cord Stimulation: A Clinical Study. Pain Physician 2010; 13:321-335 
xi Lee D, Hershey B, Bradley K, Yearwood T. Predicted effects of pulse width 
programming in spinal cord stimulation: a mathematical modeling study. 
Med Biol Eng Comput (2011) 49:765–774   
xii Grill WM, Mortimer JT. The effect of stimulus pulse duration on 
selectivity of neural stimulation. IEEE Trans Biomed Eng 1996; 43:161 –
166.