Evaluation of Clinical Outcomes of Pulse Widths <500 µS And >1000 µS During a Temporary Spinal Cord Stimulation Trial
Phase: NA
Conditions: Spinal Cord Stimulation, Pain, Back, Pain
Sponsor: Amol Soin

 
 
 
 
 
Clinical Investigational Plan 
 
 
 
 
 
 
Evaluation of Conventional and Long Pulse Widths 
During a Temporary Spinal Cord Stimulation Trial 
 
 
 
 
Sponsor: 
The Ohio Pain Clinic 
7076 Corporate Way 
Dayton, OH 45458 
 
Principal Investigator: 
Amol Soin, MD 
The Ohio Pain Clinic 
7076 Corporate Way 
Dayton, OH 45458 
 
 
Date of Issue: 
January 26, 2018 
 
Protocol Revision 
1.0 
 

 Evaluation of Conventional and Long PWs During an SCS Trial
 
 
1. STUDY SUMMARY 
 
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 µS and 
>1000 µS on clinical outcomes during a temporary SCS trial. 
Study Design and 
Scope 
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 15 subjects in order to include up to 10 subjects in the study. 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 Algostim 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. 
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. 
Primary 
Effectiveness 
Objective 
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. 
Secondary 
Effectiveness 
Objectives 
Secondary measures of therapy effectiveness will include: 
• 
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. 
• 
Number of patients who achieved ≥ 50% pain relief during the trial (from 
either arm) 
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. 

 Evaluation of Conventional and Long PWs During an SCS Trial
 
 
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 µS) or arm two (pulse width 
>1000 µS) 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: 
• 
Relevant medical history  
• 
Physical examination 
• 
Brief Pain Inventory 
• 
Demographics 
• 
Record pain ratings and pain map 
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 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 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 
 
1. STUDY DESIGN 

 Evaluation of Conventional and Long PWs During an SCS Trial
 
 
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 15 subjects in order to include up to 10 
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 Algostim 
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. 
 
Figure 6-1: Algovita SCS Post-Market Clinical Study Design  
 
 

 Evaluation of Conventional and Long PWs During an SCS Trial
 
 
1.1 OVERVIEW OF DATA COLLECTION AT STUDY VISITS 
Enrolled subjects will have up to 5 scheduled visits as follows: Enrollment, Baseline, Implant, Follow-
up at 4 and 7 days (+/–2) post implantation and a Study Exit visit as shown in Table 6.1. 
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 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 AEs 
 
 
 
 
✓ 
Table 6-1: Summary of Assessments at Each Visit 
2. STUDY PROCEDURES 
2.1 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. 
2.1.1 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 this 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 
✓ 
 
 
 
 

 Evaluation of Conventional and Long PWs During an SCS Trial
 
 
• 
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 AEs 
 
 
 
 
✓ 
Table 6-1: Summary of Assessments at Each Visit