CompaRison of Paresthesia Mapping to anatomIc Midline-based burSt Programming Strategies
Phase: NA
Conditions: Chronic Pain
Sponsor: Abbott Medical Devices

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
Reference:  
SJM-CIP-10126 
 
CRISP 
“CompaRison of paresthesia mapping to anatomIc midline-based burSt Programming 
strategies” 
Clinical Investigation Plan (CIP) 
 
Sponsor  
 
 
 
St. Jude Medical, Inc. 
6901 Preston Road 
Plano, TX  75024 
USA 
Tel: 972 309 8000 
Fax:  972 309 8150 
 
NCT Number: NCT02986074 
Document Date: May 5th, 2016 
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
PRINICPAL INVESTIGATOR SIGNATURE PAGE 
CRISP 
 
“CompaRison of paresthesia mapping to anatomIc midline-based burSt Programming 
strategies” 
 
 
Version A 
Reference #: SJM-CIP-10126 
 
I have read and agree to adhere to the clinical investigational plan and all regulatory requirements 
applicable in conducting this clinical study. 
 
 
Principal Investigator 
 
Printed name: 
____________________________________ 
Signature:_______________________________________ 
Date:  ____________________ 
 
 
 
 
 
 
 
 
 
 
 
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
 
Table of Contents 
Page 
1.0 
Synopsis ........................................................................................................................................ 5 
1.1 Study Flow Chart ................................................................................................................................................. 9 
1.2 Study Contacts ..................................................................................................................................................... 9 
2.0 
Background And Justification For Clinical Study .......................................................................... 10 
3.0 
Risks And Benefits Of The Clinical Study .................................................................................... 12 
3.1 Description Of Subject Population ..................................................................................................................... 12 
3.2 Anticipated Clinical Benefits ............................................................................................................................. 12 
3.3 Anticipated Adverse Events And Adverse Device Effects ................................................................................. 12 
3.4 Residual Risks Associated With The Device Under Investigation, As Identified In The Risk Analysis Report 13 
3.5 Risks Associated With Participation In The Clinical Study ............................................................................... 13 
3.6 Possible Interactions With Concomitant Medical Treatments And/Or Concurrent Medical Interventions ....... 13 
3.7 Steps That Will Be Taken To Control Or Mitigate The Risks ........................................................................... 13 
3.8 Risk-To-Benefit Rationale ................................................................................................................................. 13 
3.9 Description Of History Of Modifications Or Recall In Relation To Safety And Clinical Performance For Device 
Under Investigation..................................................................................................................................................... 14 
4.0 
Study Design ............................................................................................................................... 14 
4.1 Purpose ............................................................................................................................................................... 14 
4.2 Study Design And Scope .................................................................................................................................... 14 
4.3 Objectives ........................................................................................................................................................... 15 
4.4 Endpoints ........................................................................................................................................................... 16 
4.5 Inclusion And Exclusion Criteria ....................................................................................................................... 16 
4.6 Subject Population ............................................................................................................................................. 18 
4.7 Informed Consent Process .................................................................................................................................. 18 
5.0 
Device Under Investigation .......................................................................................................... 19 
5.1 Device Description ............................................................................................................................................. 19 
5.2 Device Accountability (If Applicable) ............................................................................................................... 20 
6.0 
Procedures .................................................................................................................................. 21 
6.1 Study Flow Chart ............................................................................................................................................... 21 
6.2 Procedures .......................................................................................................................................................... 22 
6.3 Enrollment Visit ................................................................................................................................................. 22 
6.4 Baseline Visit ..................................................................................................................................................... 23 
6.5 Scs Trial Implant ................................................................................................................................................ 24 
6.6 Trial Assessment Visit 1. ................................................................................................................................... 25 
6.7 Trial Assessment 2 ............................................................................................................................................. 25 
6.8 Scs Implant Procedure ........................................................................................................................................ 25 
6.9 Activation Visit .................................................................................................................................................. 26 
6.10 Scheduled Follow-Ups ....................................................................................................................................... 26 
6.11 Unscheduled Visits ............................................................................................................................................. 26 
6.12 Description Of Activities Performed By Sponsor Representatives .................................................................... 27 
6.13 Subject Study Completion .................................................................................................................................. 27 
6.14 Any Known Or Forseeable Factors That May Compromise The Outcome Of The Clinical Study Or The 
Interpretation Of The Results...................................................................................................................................... 27 
6.15 Criteria And Procedures For Subject Withdrawal Or Discontinuation .............................................................. 27 
7.0 
Compliance To Cip ...................................................................................................................... 28 
7.1 Statements Of Compliance ................................................................................................................................. 28 
7.2 Adherence To The Clinical Investigation Plan .................................................................................................. 29 
7.3 Repeated And Serious Non-Compliance ............................................................................................................ 30 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
8.0 
Adverse Event, Adverse Device Effect, Device Deficiency .......................................................... 30 
8.1 Definitions .......................................................................................................................................................... 30 
8.2 Procedure For Assessing, Recording, And Reporting Adverse Events, Device Deficiencies/Complaints, Adverse 
Device Effects, Serious Adverse Events, And Serious Adverse Device Effects: ....................................................... 32 
8.3 Subject Death ..................................................................................................................................................... 33 
9.0 
Data Management ....................................................................................................................... 33 
9.1 Data Management Plan ...................................................................................................................................... 33 
9.2 Document And Data Control .............................................................................................................................. 34 
10.0 Monitoring .................................................................................................................................... 34 
11.0 Regulatory Inspections ................................................................................................................ 34 
12.0 Statistical Considerations ............................................................................................................ 35 
12.1 Statistical Design, Hypotheses, Method And Analytical Procedures ................................................................. 35 
12.2 Sample Size ........................................................................................................................................................ 35 
12.3 Pass/Fail Criteria To Be Applied To The Results Of The Clinical Study .......................................................... 35 
13.0 Document Retention .................................................................................................................... 35 
14.0 Amendments To Clinical Investigational Plan .............................................................................. 36 
15.0 Investigation Suspension Or Termination .................................................................................... 36 
15.1 Premature Termination Of The Whole Clinical Study Or Of The Clinical Study In One Or More Investigational 
Sites 36 
15.2 Resuming The Study After Temporary Suspension ........................................................................................... 38 
15.3 Study Conclusion ............................................................................................................................................... 38 
16.0 Publication Policy ........................................................................................................................ 38 
17.0 Bibliography ................................................................................................................................. 38 
Appendix A: Abbreviations ................................................................................................................... 40 
Appendix B: Cip Revision History ......................................................................................................... 41 
Appendix C: Declaration Of Helsinki ..................................................................................................... 42 
Appendix D: List Of Clinical Investigation Sites And Irb/Ec ................................................................... 43 
Appendix E: Sample Informed Consent ................................................................................................ 44 
Appendix F: Case Report Forms .......................................................................................................... 45 
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
 
1.0 
SYNOPSIS  
 
Title: 
CompaRison of paresthesia mapping to anatomIc midline-based burSt 
Programming strategies 
Acronym: 
CRISP 
Purpose: 
The primary purpose of this study is to compare the therapeutic efficacy of 
the conventional, paresthesia mapping-based burst spinal cord stimulation 
(SCS) implantation strategy to a more novel, anatomic midline-based 
approach that has the potential to streamline the workflow associated with 
the SCS treatment continuum.   
Primary Objective: 
• 
Compare pain relief provided by paresthesia mapping-based burst trial 
to anatomical midline-based burst trial 
Secondary 
Objectives: 
• 
Compare subject preference between the paresthesia mapping-based 
and anatomical midline-based burst trial 
• 
Compare improvements in quality of life and disability between the 
paresthesia mapping-based burst trial and the anatomical midline-
based burst trial 
• 
Evaluate pain relief, improvements in quality of life, disability, and 
subject satisfaction at 3, 6 and 12 months after permanent implant by 
burst SCS delivered through electrodes positioned using either 
anatomical midline-based or paresthesia based implantation 
Primary Endpoint: 
• 
Changes in low back and lower limb pain between baseline and trial 
assessments  
Secondary 
Endpoints: 
• 
Comparison of subject preference between the 2 lead implantation 
techniques during the SCS trial  
• 
Changes in low back and lower limbs pain between baseline and at 3, 
6 and 12 months after permanent implant (evaluated using Visual 
Analog Scale (VAS) assessments) 
• 
Changes in quality of life assessed using the EQ-5D questionnaire and 
in disability assessed using the Oswestry Disability Index (ODI) 
between baseline, trial assessments and at 3, 6 and 12 months after 
permanent implant 
• 
Evaluate subject satisfaction at 3, 6 and 12 months after permanent 
implant 
Design: 
This is a prospective, multicenter, double-blinded, feasibility study 
consisting of two phases: SCS trial and permanent implant follow up. 
 
After baseline evaluation, subjects will undergo SCS trial using the St. 
Jude Medical (SJM) Invisible Trial system.  During the trial implant, two 
SCS leads will be implanted, one using the standard paresthesia-based 
mapping, and the other using the anatomical midline-based technique. 
Subjects will be blinded and then randomized 1:1 to receive burst SCS 
using one of the 2 leads (lead placed using paresthesia-based mapping or 
the anatomical midline) for 2 weeks, and will then receive burst stimulation 
on the alternate lead for an additional 2 weeks.  Therapeutic efficacy for 
stimulation delivered through each of the 2 leads will be evaluated at the 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
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end of the 2-week trial period during trial assessment visits 1 and 2. 
 
Subjects who underwent a successful trial (≥50% overall pain relief) will 
then be implanted with a SJM Proclaim™, Prodigy™ or Prodigy MRI™ 
system.  The lead activated will depend on the subject’s preference 
following the trial.  It the subject has no preference, the lead placed using 
the anatomic midline-based technique will be activated.  The subject will 
then be followed for 12 months to assess the long term treatment 
outcome.   
 
Subjects who do not experience a  ≥50% overall pain relief on either of the 
2 leads will exit the study.   
 
This clinical study will be conducted in up to 3 centers in the EU. 
 
Approximately 50 subjects will be enrolled in this study. 
 
Subjects will be followed up for 12 months. 
Devices used: 
• 
SJM Invisible trial™ system 
• 
Proclaim™, Prodigy™ or Prodigy MRI™ Implantable Pulse Generator 
(IPG) 
• 
Clinician Programmer  
• 
Patient Programmer 
• 
IPG recharger (for Prodigy MRI™ patients) 
Study Population: 
Failed back surgery syndrome (FBSS) subjects with predominant low back 
pain eligible for a SCS trial will be considered for enrollment in this study.  
Inclusion/Exclusion 
Criteria  
Inclusion Criteria 
• 
Subject is able to provide informed consent to participate in the study; 
• 
Subject is 18 years of age or older; 
• 
Subject has failed to respond to at least 6 months of conventional 
treatment including pharmacological treatment, physical therapy, 
epidural injections and/or radiofrequency therapy as per NICE Tag 
0159; 
• 
FBSS subjects with predominant low back pain; 
• 
Subject has a lower back pain intensity of at least 6.0 out of 10.0 on 
the VAS at baseline; 
• 
Subject is on  stable pain medications with a total opioid equivalent of 
120 mgs a day or less for at least 28 days prior to enrolling in this 
study, and  is willing to stay on those medications with no dose 
adjustments until activation of the permanently implanted SCS device; 
• 
Subject’s medical record has been evaluated by the Investigator to 
ensure that the subject is a good candidate for a neurostimulation 
system;  
• 
Subject is willing to cooperate with the study requirements including 
compliance with the regimen and completion of all office visits; 
• 
Female candidates of child-bearing potential agree to commit to the 
use of an effective method of contraception (including but not limited to 
sterilization, barrier devices, oral contraceptives, intrauterine devices 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
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(IUDs), condoms, rhythm method, or abstinence) for the duration of 
the study   
 
Exclusion Criteria 
• 
Subjects with significant scoliosis even if surgically corrected 
• 
 Subject is currently participating in a clinical investigation that includes 
an active treatment arm; 
• 
Subject has been implanted with or participated in a trial period for a 
neurostimulation system; 
• 
Subject has an infusion pump; 
• 
Subject has  evidence of an active disruptive psychological or 
psychiatric disorder as determined as per standard of care; 
• 
Subject has a current diagnosis of a coagulation disorder, bleeding 
diathesis, progressive peripheral vascular disease or uncontrolled 
diabetes mellitus; 
• 
Subject has a current diagnosis of a progressive neurological disease 
as determined by the Investigator; 
• 
Subject is immunocompromised; 
• 
Subject has an existing medical condition that is likely to require 
repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple 
sclerosis, acoustic neuroma, tumor); 
• 
Subject has history of cancer requiring active treatment in the last 12 
months; 
• 
Subject has an existing medical condition that is likely to require the 
use of diathermy in the future; 
• 
Subject has documented history of allergic response to titanium or 
silicone; 
• 
Subject has a documented history of substance abuse (narcotics, 
alcohol, etc.) or substance dependency in the 6 months prior to 
baseline data collection; 
• 
Female candidates of child bearing potential that are pregnant 
(confirmed by positive urine/blood pregnancy test). 
Data Collection 
FBSS subjects with predominant low back pain will be screened as per the 
inclusion/exclusion criteria, and those who successfully meet these criteria 
and provide their consent will be considered for enrollment.  
 
Subjects will undergo a baseline assessment to collect primary and 
secondary outcome measures prior to the SCS trial. Specifically, 
assessments will include: pain rating as assessed by the VAS, quality of 
life as assessed by EQ-5D and disability as assessed by ODI. 
 
Trial phase: 
Therapeutic efficacy of trial SCS will be evaluated during trial assessment 
visits 1 and 2 using the VAS, EQ-5D, and ODI. . Pain diaries will be used 
to record subjects’ pain during the trial period. Subject preference for 
stimulation delivered through either of the 2 leads will also be recorded. 
Subjects who experienced at least a 50% overall pain reduction at either 
of the trial assessment visits will be considered for permanent implant. 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
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Permanent implant follow up: 
Subjects who receive permanent SCS implant will be followed up for 12 
months. Assessments, performed at the 3, 6 and 12 month visits, will 
include: pain rating as assessed by the VAS, quality of life as assessed by 
EQ-5D, disability as assessed by the ODI, and subject satisfaction. Pain 
diaries will be used to record subjects pain during the last week before 
each of the follow up visits.  
 
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
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1.1 
STUDY FLOW CHART 
 
1.2 
STUDY CONTACTS 
Jeff Kramer 
Lalit Venkatesan 
Filippo Agnesi 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
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2.0 
BACKGROUND AND JUSTIFICATION FOR CLINICAL STUDY 
Spinal cord stimulation (SCS) is a well-established therapy for the treatment of chronic, 
intractable pain. In a systematic meta-analysis of the literature, (Taylor et al. 2006) reported that 
SCS reduces pain, improves quality of life, reduces analgesic use, allows some patients to 
return to work and may also result in significant cost savings over time, while having minimally 
significant adverse events in patients with neuropathic back and/or leg pain.  
 
Patients receiving conventional tonic SCS (electrical pulses delivered in the 40-60Hz stimulation 
frequency range) experience paresthesia or a tingling sensation. Burst SCS is a newer 
paradigm currently approved for use in the European Union and Australia to treat chronic pain 
conditions.  Burst stimulation eliminates or greatly reduces the incidence of paresthesia 
(Courtney et al. 2014), and it entails delivering groups of pulses called burst trains (A) repeated 
at a burst rate (B); within each burst train, several pulses are issued at an intra-burst rate (C) 
(See Figure 1). Individual pulses are characterized by a pulse amplitude (D) and pulse width. 
 
Figure 1: Burst Pattern 
 
The current conventional strategy for implanting SCS leads involves physiologically mapping the 
dermatomal areas encompassing the painful target location using traditional tonic stimulation 
parameters and adjusting the lead position accordingly. Although effective, this process can 
prove cumbersome for both the patient and the clinician programmer as different combinations 
of electrode contacts and polarities have to be tested in order to identify the optimal 
configuration that maximizes the overlap of the pain and paresthesia regions while minimizing 
stimulation-induced side effects. While this process can be optimal for tonic SCS, it is unclear if 
it represents the ideal approach for burst SCS.  As burst SCS can be delivered without 
producing stimulation-induced sensory side effects, the physiological-mapping procedure using 
tonic stimulation can potentially be eliminated from the workflow. 
 
Of late, anatomical midline-based lead implantations have been performed successfully (Al-
Kaisy et al. 2014).  Two leads are inserted at the T12 level and tunneled such that the tip of the 
first lead typically is positioned at the start of the T8 segment while the tip of the second lead is 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
positioned at the T9 segment.  Such an implantation strategy provides coverage extending from 
T8-T11 (figure 2) and maximizes the number of contacts in the T9-T10 junction.  Use of a high 
frequency stimulation paradigm in two of the contacts in one lead at the T9-T10 junction has 
resulted in sustained long-term pain relief over a period of 24 months (Al-Kaisy et al. 2014) in 65 
chronic pain patients.   
 
 
 
Figure 2: X-ray of anatomic midline-based lead implants spanning the T8 to T11 vertebral 
segments. 
 
The current implantation procedure for burst stimulation involves placement of leads using tonic 
stimulation based physiological mapping.  Anatomical midline-based lead implantation has the 
potential to reduce the time associated with the surgical procedure, and thus could assist in 
establishing a more streamlined and time-efficient treatment continuum while using burst SCS. 
As anatomical midline-based lead implantation does not require patient input, this novel 
approach will improve patient’s comfort, as sedation can be maintained constant throughout the 
procedure.  However, the therapeutic efficacy of burst stimulation delivered through the leads 
placed using the anatomical midline-based approach is unknown. In this feasibility study, we 
aim to compare the therapeutic efficacy of the conventional, paresthesia mapping-based burst 
spinal cord stimulation (SCS) programming strategy to the anatomic midline-based approach 
while using burst stimulation during a SCS trial.  Additionally, the study design also includes a 
long-term follow up period in order to assess the pain-relief provided by burst stimulation 
delivered using the lead implant technique preferred by the subject at 3,6 and 12 months 
following the permanent implant.  
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
3.0 
 RISKS AND BENEFITS OF THE CLINICAL STUDY 
Only devices that are currently market approved for treatment of chronic intractable pain of the 
trunk and limbs will be used during this study.  Subjects will be asked to stabilize their 
medication regimen with no dose adjustments until activation of the permanently implanted SCS 
device.  
 
3.1 
DESCRIPTION OF SUBJECT POPULATION 
Approximately 50 subjects will be enrolled in the study. The study population consists of failed 
back surgery syndrome (FBSS) subjects with predominant low back pain eligible for a SCS 
system trial. 
 
3.2 
ANTICIPATED CLINICAL BENEFITS 
We anticipate that the participants in this study will experience reduction of pain intensity 
commonly afforded by SCS.  
 
3.3 
ANTICIPATED ADVERSE EVENTS AND ADVERSE DEVICE EFFECTS 
In addition to those risks commonly associated with surgery, the following risks are associated 
with implanting or using this neurostimulation system for SCS: 
Anticipated adverse events 
Undesirable changes in stimulation, which may be related to cellular changes in tissue around 
the electrodes, changes in electrode position, loose electrical connections, or lead failure 
Lead migration, causing changes in stimulation and/or reduced pain relief 
Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from 
placement of a lead in the epidural space 
Cerebrospinal fluid (CSF) leakage 
Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant 
Persistent pain at the electrode or IPG site 
Seroma (mass or swelling) at the IPG site 
Infection of the lead extension at the exit zone during trial or infection of the IPG site 
Allergic or rejection response to implant materials 
Implant migration or skin erosion around the implant 
Anticipated adverse device effects 
Battery failure 
Battery leakage 
 
These adverse events and adverse device effects are not specific to the study, but related to the 
approved SCS implant procedure. 
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
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3.4 
RESIDUAL RISKS ASSOCIATED WITH THE DEVICE UNDER INVESTIGATION, AS 
IDENTIFIED IN THE RISK ANALYSIS REPORT 
There are no residual risks associated with the stimulation protocol under investigation. 
 
3.5 
RISKS ASSOCIATED WITH PARTICIPATION IN THE CLINICAL STUDY 
In this study, the position of one lead will be optimized using a paresthesia-based mapping 
approach ensuring that the subjects will receive adequate paresthesia coverage. The second 
lead will be positioned using an anatomical midline-based approach. The anatomical midline-
based approach is a novel technique and the subjects might not receive adequate pain relief on 
use of the lead placed using that technique.  In that case, activation of the paresthesia mapping-
based lead is expected to mitigate the issue and provide the subject with adequate pain relief. 
Additionally, both the two leads will be implanted using standard SCS surgical techniques, so 
we do not foresee any additional risks associated with the participation in this clinical study 
compared to the SCS treatment continuum. 
 
3.6 
POSSIBLE INTERACTIONS WITH CONCOMITANT MEDICAL TREATMENTS AND/OR 
CONCURRENT MEDICAL INTERVENTIONS 
There are no possible interactions with concomitant medical treatment and/or concurrent 
medical intervention beyond those associated with standard medical care using SCS. 
 
3.7 
STEPS THAT WILL BE TAKEN TO CONTROL OR MITIGATE THE RISKS 
This study consists of implantation of leads using two different techniques.  The conventional 
paresthesia mapping-based procedure is currently being utilized in the SCS treatment 
continuum while using burst stimulation and was shown to be successful in treating chronic pain 
associated with FBSS (Shu et al. 2014, de Vos et al. 2015).  Recent data shows that the newer 
anatomic midline-based lead implants deliver adequate pain relief while using high frequency 
stimulation, but therapeutic efficacy provided by burst stimulation is unknown.  During the 2-
week trial, the subject might not get adequate pain relief while using burst stimulation delivered 
using the anatomic midline-based lead.  But, the trial’s phase involving burst stimulation 
delivered through the paresthesia mapping-based lead will ensure that the subject undergoes a 
SCS trial conducted according to standard clinical practice.  
 
3.8 
RISK-TO-BENEFIT RATIONALE 
Subjects participating in this study will incur risks that are no greater in significance when 
compared to risks associated with standard SCS treatment continuum. The anatomic midline-
based lead implantation technique is expected to reduce the time associated with lead 
implantation surgery, thus reducing the burden on the patients as well as clinicians. The 
procedure to implant the SCS leads will be shorter than the tonic stimulation based paresthesia 
mapping procedure.  As a result, X-ray radiation exposure may also be reduced.  Subjects can 
also be under conscious sedation for the entire duration of the procedure compared to having to 
provide input regarding the paresthesia coverage during physiologic mapping based lead 
implant procedures.  

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
 
 
3.9 
DESCRIPTION OF HISTORY OF MODIFICATIONS OR RECALL IN RELATION TO 
SAFETY AND CLINICAL PERFORMANCE FOR DEVICE UNDER INVESTIGATION 
There have been no modifications or recalls in relation to safety and clinical performance of the 
devices utilized in this study. 
 
4.0 
STUDY DESIGN 
4.1 
PURPOSE 
The primary purpose of this study is to compare the therapeutic efficacy of the conventional, 
paresthesia mapping-based burst SCS implant strategy to a more novel, anatomic midline-
based approach that has the potential to streamline the workflow associated with the SCS 
treatment continuum.   
 
4.2 
STUDY DESIGN AND SCOPE 
This study is a prospective, multicenter, single-blinded feasibility study consisting of two phases: 
SCS trial and permanent implant follow up. 
 
Patients recommended by the Principal Investigator as a candidate and who meet the standard 
requirements will be approached to participate in this study. Patients that meet the 
inclusion/exclusion criteria and sign the informed consent will be enrolled in the study and 
undergo baseline assessment to collect primary and secondary outcome measures prior to the 
SCS trial. Specifically, assessments will include pain ratings as assessed by visual analog scale 
(VAS), quality of life as assessed by the EQ-5D and disability as assessed by the Oswestry 
disability index (ODI).  
 
Subjects will subsequently undergo a SCS trial using the St. Jude Medical (SJM) Invisible Trial 
system.  During the trial implant, two SCS leads will be implanted using standard surgical 
techniques. One lead will be implanted using paresthesia mapping to maximize the overlap 
between painful regions and evoked paresthesia according to standard clinical practice. A 
second lead will be implanted using a novel anatomical midline-based approach. Under 
fluoroscopic guidance, the lead will be positioned above the anatomical midline such that it 
extends over the T9-T10 junction.  
 
Subjects will be randomized 1:1 to receive burst stimulation using one of the 2 leads (lead 
placed using paresthesia mapping or lead placed by anatomic midline-based approach or vice 
versa), and will be blinded to the randomization order.  
 
The SCS trial will consist of two phases, and will last for a total of 4 weeks. 
 
During the first trial phase, burst SCS will be delivered for two weeks using the first lead in the 
randomization sequence.  After two weeks, subjects will assess the pain level, quality of life and 
disability associated with stimulation delivered.  
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
Subjects will then cross over to the second trial phase during which burst stimulation will be 
delivered for an additional two weeks using the second lead in the randomization sequence.  
 
At the end of the second trial phase, subjects will assess pain level, quality of life and disability 
associated with stimulation delivered using the second lead. Subject preference for stimulation 
delivered during the two trial phases will also be recorded during this visit.   
 
If the VAS score during either of the two trial assessments is reduced by at least 50% compared 
to the baseline score, the subject will be considered for permanent SCS implant.  Subjects who 
do not experience a ≥50% overall pain relief on either of the 2 leads will exit the study.   
 
Subjects who underwent a successful trial (≥50% overall pain relief) will then be implanted with 
a SJM Proclaim™, Prodigy™ or Prodigy MRI™ system.  The lead activated will depend on the 
subject’s preference following the trial.  It the subject has no preference; the lead placed using 
the anatomic midline-based technique will be activated.  The subject will then be followed for 12 
months to assess the long term treatment outcome.  Follow up visits will occur at 3, 6 and 12 
months after permanent implant. During each of these visits, subjects will rate their pain using 
the VAS, their quality of life using the EQ-5D, their disability using the ODI. 
 
The total duration of the study is expected to be approximately 2 years. 
 
The clinical study will be conducted in up to 3 centers in the E.U. 
 
4.2.1 
Number of subjects required to be included in the study 
Approximately 50 subjects will be enrolled in this study. Enrollment will end when 40 subjects 
will have received permanent SCS implant. 
 
4.2.2 
Estimated time needed to enroll this subject population 
The study may continue up to 2 year, dependent on the rate of enrollment. 
 
4.3 
OBJECTIVES 
4.3.1 
Primary Objective 
• 
Compare pain relief provided by paresthesia mapping-based burst trial to anatomical 
midline-based burst trial 
4.3.2 
Secondary Objective 
• 
Compare subject preference between the paresthesia mapping-based anatomical midline-
based burst trial 
• 
Compare improvements in quality of life and disability between the paresthesia mapping-
based burst trial and the anatomical midline-based burst trial 
• 
Evaluate pain relief, improvements in quality of life, disability, and subject satisfaction at 3, 6 
and 12 months after permanent implant by burst SCS delivered through electrodes 
positioned using anatomical midline-based implantation  
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 16 of 45 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, 
disclosed or used without the express written consent of St. Jude Medical 
 
4.4 
ENDPOINTS 
4.4.1 
Primary Endpoint 
• 
Changes in low back and lower limb pain between baseline and SCS trial assessments. 
 
4.4.2 
Secondary Endpoint 
• 
Comparison of subject preference between the 2 lead implantation techniques during the 
SCS trial  
• 
Changes in low back and lower limbs pain between baseline and at 3, 6 and 12 months after 
permanent implant (evaluated using Visual Analog Scale (VAS) assessments) 
• 
Changes in quality of life assessed using the EQ-5D questionnaire and in disability 
assessed using the Oswestry Disability Index (ODI) between baseline, trial assessments 
and at 3, 6 and 12 months after permanent implant 
• 
Evaluate subject satisfaction at 3, 6 and 12 months after permanent implant 
 
4.5 
INCLUSION AND EXCLUSION CRITERIA 
A subject, who meets all of the inclusion criteria, and none of the exclusion criteria, is eligible to 
participate in this study.  
 
All subjects enrolled in the clinical study (including those withdrawn from the clinical study or lost 
to follow-up) will be accounted for and documented, assigning an identification code linked to 
their names, alternative identification or contact information. 
 
This log will be kept up to date throughout the clinical study by the principal investigator or 
his/her authorized designee. To ensure subject privacy and confidentiality of data this log must 
be maintained throughout the clinical study at the clinical site. 
 
To participate in this clinical subject, the subject must meet all of the following inclusion criteria: 
 
4.5.1 
Inclusion Criteria 
• 
Subject is able to provide informed consent to participate in the study; 
• 
Subject is 18 years of age or older; 
• 
Subject has failed to respond to at least 6 months of conventional treatment including 
pharmacological treatment, physical therapy, epidural injections and/or radiofrequency 
therapy as per NICE Tag 0159; 
• 
FBSS subjects with predominant low back pain;  
• 
Subject has a low back and pain intensity of at least 6.0 out of 10.0 on the VAS at baseline; 
• 
Subject is on  stable pain medications with a total opioid equivalent of 120 mgs a day or less 
for at least 28 days prior to enrolling in this study, and  is willing to stay on those 
medications with no dose adjustments until activation of the permanently implanted SCS 
device; 
• 
Subject’s medical record has been evaluated by the Investigator to ensure that the subject is 
a good candidate for a neurostimulation system;  

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 17 of 45 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, 
disclosed or used without the express written consent of St. Jude Medical 
• 
Subject is willing to cooperate with the study requirements including compliance with the 
regimen and completion of all office visits; 
• 
Female candidates of child-bearing potential agree to commit to the use of an effective 
method of contraception (including but not limited to sterilization, barrier devices, oral 
contraceptives, intrauterine devices (IUDs), condoms, rhythm method, or abstinence) for the 
duration of the study   
 
Subjects are not eligible for clinical study participation if they meet any of the following exclusion 
criteria: 
 
4.5.2 
Exclusion Criteria 
• 
Subjects with significant scoliosis even if surgically corrected; 
• 
Subject is currently participating in a clinical investigation that includes an active treatment 
arm; 
• 
Subject has been implanted with or participated in a trial period for a neurostimulation 
system; 
• 
Subject has an infusion pump; 
• 
Subject has  evidence of an active disruptive psychological or psychiatric disorder as 
determined as per standard of care; 
• 
Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive 
peripheral vascular disease or uncontrolled diabetes mellitus; 
• 
Subject has a current diagnosis of a progressive neurological disease as determined by the 
Investigator; 
• 
Subject is immunocompromised; 
• 
Subject has an existing medical condition that is likely to require repetitive MRI evaluation in 
the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor); 
• 
Subject has history of cancer requiring active treatment in the last 12 months; 
• 
Subject has an existing medical condition that is likely to require the use of diathermy in the 
future; 
• 
Subject has documented history of allergic response to titanium or silicone; 
• 
Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance 
dependency in the 6 months prior to baseline data collection; 
• 
Female candidates of child bearing potential that are pregnant (confirmed by positive 
urine/blood pregnancy test). 
 
 
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 18 of 45 
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or used without the express written consent of St. Jude Medical 
4.6 
SUBJECT POPULATION 
 
The study population consists of FBSS patients with a diagnosis of chronic low back pain accompanied 
by lower limb pain, and eligible for a SCS trial. 
  
4.6.1 
Subject Screening 
All subjects presenting at the investigational site can be screened by a member of the investigational 
team previously trained on the CIP and delegated to do so. 
 
Subjects who do not meet the inclusion/exclusion criteria will not be eligible to participate in this study. 
 
Subjects meeting the inclusion/exclusion criteria will be fully informed about the study and asked to 
participate in the study. In case the subject agrees, a duly signed and dated Patient Informed Consent 
will be obtained. 
 
4.6.2 
Point of Enrollment 
Subjects are considered enrolled in the study from the moment the subject has provided written Patient 
Informed Consent, has been screened for inclusion/exclusion criteria and his/her enrollment form has 
been completed. (Refer to section 4.7 for the Informed Consent Process).  
 
4.7 
INFORMED CONSENT PROCESS 
4.7.1 
General process 
Prior to enrolling in the clinical study and conducting study-specific procedures, all subjects will be 
consented, as required by applicable regulations and the center’s IRB/EC.  Informed consent must be 
obtained from each subject prior to any study related procedures. The consent form must be signed 
and dated by the subject and by the person obtaining the consent. 
 
The principal investigator or his/her authorized designee will conduct the Informed Consent Process. 
This process will include a verbal discussion with the subject on all aspects of the clinical study that are 
relevant to the subject’s decision to participate in the clinical study.  
 
The subject shall be provided with the informed consent form that is written in a language that is 
understandable to the subject and has been approved by the center’s IRB/EC.  Failure to obtain 
informed consent from a subject prior to study enrollment should be reported to St. Jude Medical within 
5 working days and to the reviewing center’s IRB/EC/ consistent with the center’s IRB/EC reporting 
requirements.  
 
 
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 19 of 45 
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or used without the express written consent of St. Jude Medical 
5.0 DEVICE UNDER INVESTIGATION 
5.1 
DEVICE DESCRIPTION 
In this study, the SJM Invisible trial system and the Proclaim™, Prodigy ™ or Prodigy MRI™ 
neurostimulation system will be used.  
Table 1:  Description of Proposed Devices 
Device 
Component 
Model/Type 
Investigational or 
Market Released 
SJM Invisible trial external pulse 
generator (EPG) 
3599 (Base), 3032 (Header) 
Released 
SJM Invisible trial Clinician Programmer 
3870, 3872 
Released 
SJM Invisible trial Patient Controller 
3871, 3873 
Released 
SJM Lead extension 
338X 
Released 
SJM Proclaim internal pulse generator 
(IPG) 
3660, 3662 
Released 
SJM Prodigy IPG 
3799 
Released 
SJM Prodigy MRI IPG 
3772 
Released 
SJM Clinician Programmer App 
3874 
Released 
SJM Patient Controller App 
3875 
Released 
SJM Rapid programmer System 
3831,3382 
Released 
Prodigy MRI Patient programmer 
3855 
Released 
Prodigy MRI charger 
3730 
Released 
SJM Octrode™ lead 
318X 
Released 
SJM Cinch™ Lead Anchor 
1194 
Released 
SJM Swift-Lock™ Anchor 
1192 
Released 
 
• 
SJM Invisible trial™ external pulse generator (EPG): a 16 channels, software controlled, battery 
powered, external stimulator that generates the electrical pulses to be used during the trial phase of 
the study  
• 
SJM Invisible trial Clinician Programmer: software compatible with iOS™ App 8.1 or later to be 
used on iPad mini™; enables the clinician to program the SJM Invisible trial EPG 
• 
SJM Invisible trial Patient Controller: software compatible with iOS™ App 8.1 or later to be used 
on iPad touch™; enables patient-controlled therapy adjustment of the SJM Invisible trial EPG 
• 
SJM Percutaneous trial lead: sterile stimulating electrode placed in the epidural space of the 
spinal cord and connected to the EPG 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 20 of 45 
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or used without the express written consent of St. Jude Medical 
• 
SJM Lead extension: sterile extension that connects the pulse generator to the stimulating 
electrode 
• 
SJM Proclaim™ internal pulse generator (IPG): a 16 channels, software controlled, battery 
powered, internal stimulator to be used during the follow up phase of the study that generates the 
electrical pulses 
• 
SJM Prodigy IPG: a 16 channels, software controlled, rechargeable battery powered, internal 
stimulator to be used during the follow up phase of the study that generates the electrical pulses  
• 
SJM Prodigy MRI™ IPG: a 16 channels, software controlled, rechargeable battery powered, 
internal stimulator to be used during the follow up phase of the study that generates the electrical 
pulses  
• 
SJM Clinician Programmer App: software compatible with iOS™ App 8.3 or later to be used on 
iPad mini™; enables the clinician to program the Proclaim IPG 
• 
SJM Patient Controller App: : software compatible with iOS™ App 8.1 or later to be used on iPad 
touch™; enables patient-controlled therapy adjustment of the Proclaim IPG 
• 
SJM Rapid Programmer™ system:  device designed to be used by the clinician to program the 
Prodigy MRI™ IPG 
• 
SJM Prodigy MRI™ Patient Programmer: device designed to enable patient-controlled 
adjustment of the Prodigy MRI™ IPG 
• 
SJM Prodigy MRI™ Recharger: provides the capability to recharge the Prodigy MRI™ battery 
• 
SJM Octrode™ lead: sterile stimulating electrode that placed in the epidural space of the spinal 
cord and connected to the Proclaim IPG 
• 
SJM Cinch™ Lead Anchor: securing device designed to reduce lead migration and breakage 
• 
SJM Swift-Lock™ Anchor: securing device designed to reduce lead migration and breakage 
 
5.2 
DEVICE ACCOUNTABILITY (if applicable) 
Device accountability is not required in post market studies.  

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 21 of 45 
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or used without the express written consent of St. Jude Medical 
 
6.0 PROCEDURES 
6.1 
STUDY FLOW CHART 
 
 
Figure 3: Flow Chart 
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 22 of 45 
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or used without the express written consent of St. Jude Medical 
 
6.2 
PROCEDURES 
The clinical study will be conducted in accordance with the CIP.  All parties participating in the conduct 
of the clinical study will be qualified by education, training, or experience to perform their tasks and this 
training will be documented appropriately. 
 
The clinical study will not commence until St. Jude Medical receives written approval from the IRB/EC 
and relevant regulatory authorities and all required documents have been collected from the site(s). 
 
Table 1: List of all study specific activities/procedures 
                Visit 
 
 
 
 
 
Study Activity 
Enrollment 
 
Baseline 
Screening 
SCS Trial  
Trial Assessment 
1 
Trial assessment 
2 
SCS Implant  
procedure 
Activation 
Follow up Visits* 
Informed Consent Process 
X 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
Screening 
X 
 
 
 
 
 
 
 
VAS assessment 
 
X 
 
X 
X 
 
 
X 
EQ-5D questionnaire 
 
X 
 
X 
X 
 
 
X 
ODI questionnaire 
 
X 
 
X 
X 
 
 
X 
Provide pain diary 
 
 
X 
X 
 
 
X 
X 
Collect pain diary 
 
 
 
X 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
Subject Preference 
questionnaire 
 
 
 
 
X 
 
 
 
Trial leads implant 
 
 
X 
 
 
 
 
 
EPG programming 
 
 
X 
X 
 
 
 
 
Permanent implant 
 
 
 
 
 
X 
 
 
IPG Programming 
 
 
 
 
 
 
X 
 
Subject Satisfaction 
questionnaire 
 
 
 
 
 
 
 
X 
* Follow up visit assessments will be performed after activation visit at weeks 12 (84±7 days), 26 
(182±7 days), and 52 (365±7 days). 
 
6.3 
ENROLLMENT VISIT  
The following enrollment activities are performed after the subject has been screened and must occur 
before any study procedure/visit. 
 
• 
The principal or delegated study personnel are responsible for screening all potential subjects to 
determine subject eligibility for the study 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 23 of 45 
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or used without the express written consent of St. Jude Medical 
• 
Record enrollment information (name of the study, date of consent and Inclusion/exclusion 
information) in the hospital records and complete and submit the Enrollment form in a timely 
manner (recommended within 5 days)  
• 
Notification of enrollment to the sponsor will take place only when the sponsor receives the 
enrollment form  
 
NOTE: As soon as the subject signs the Patient Informed Consent, adverse events need to be reported 
according to the guidelines mentioned in section 8. 
 
If a subject does not meet all inclusion criteria or meets any of the exclusion criteria, the subject cannot 
participate in the study and cannot be enrolled.  
 
In case the subject was already consented to participate in the study, but does not meet 
inclusion/exclusion criteria, the following actions will be taken. 
 
If study procedure/device implant has not occurred: 
• 
Document enrollment information (name of the study, date of consent and inclusion/exclusion) in 
the hospital records; complete the Enrollment and Withdrawal Forms. The form must be 
authorized / approved by the principal or delegated investigator. 
o Inform the subject about the withdrawal.  
o The EC/IRB and CA should be notified appropriately about any deviations with regards to 
obtaining the informed consent. 
 
 If study procedure/device implant has occurred: 
• 
Document enrollment information (name of the study, date of consent and inclusion/exclusion) in 
the hospital records; complete the Enrollment and Withdrawal Forms. The form must be 
authorized / approved by the principal or delegated investigator. 
o Complete study deviation for inclusion/exclusion not met 
o The EC/IRB and CA should be notified appropriately about any deviations with regards to 
obtaining the informed consent. 
 
The following activities and assessments will be performed during enrollment: 
 
Timing of visit 
Activities at visit 
Case Report Form 
Enrollment 
• 
Subject signs informed consent  
• 
Subject is screened for inclusion/exclusion 
criteria 
• 
Subject is enrolled 
• 
Inclusion/Exclusion Form 
• 
Enrollment Form 
 
 
6.4 
BASELINE VISIT 
Baseline screening of subjects can occur at the same visit of enrollment after the informed consent has 
been obtained. Subjects will be screened according to inclusion/exclusion criteria. Subjects will perform 
assessment of pain levels (VAS), quality of life (EQ-5D) and disability (ODI). 
 
Subjects will be provided with a pain diary, instructed to fill it daily and return it at the SCS trial implant 
visit. 
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 24 of 45 
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or used without the express written consent of St. Jude Medical 
The following activities and assessments will be performed during baseline visit: 
 
Timing of visit 
Activities at visit 
Case Report Form 
Baseline 
• 
Subject assessments of current pain levels, 
quality of life and disability 
• 
VAS Form 
• 
EQ-5D Form 
• 
ODI Form 
 
6.5 
SCS TRIAL IMPLANT 
During the trial implant, two SCS leads will be implanted using standard surgical techniques. One lead 
will be implanted using paresthesia mapping to maximize the overlap between painful regions and 
evoked paresthesia according to standard clinical practice. A second lead will be implanted using a 
novel anatomical midline-based placement. Under fluoroscopic guidance the lead will be positioned 
above the anatomical midline such that it extends over the T9-T10 junction. No tonic stimulation based 
paresthesia mapping will be performed to implant this lead. Leads will be connected to the EPG such 
that channels 1-8 will provide stimulation through the paresthesia mapping-based lead and channels 9-
16 to the anatomical midline-based lead. 
 
Subjects will be randomized 1:1 to either lead sequence (paresthesia lead first followed by anatomical 
lead or vice versa). Only stimulation programs using the lead selected by the randomization will be 
programmed in the EPG. When programming stimulation delivered with the lead implanted using the 
paresthesia-based placement, paresthesia mapping will be used to define the optimal contacts to 
activate.  When programming stimulation delivered with the lead implanted using the anatomical-
midline placement, a generalized bipolar stimulation approach will be used. 
  
During the programming sessions, burst stimulation amplitude will be slowly increased up to the point 
where the subject feels any stimulation induced sensation (paresthesia, warmth, heaviness, cramping); 
this intensity value will constitute the Threshold for Perception (TP).  Intensity will be then set at 60% of 
TP and the subject will be asked to move around, walk and cough. If sensations are still experienced, 
amplitude will be reduced in 0.05 mA steps until no sensations are experienced during the 
aforementioned activities. This intensity level will be used to define the target intensity and the 
stimulator will be programmed to allow the subjects to increase stimulation intensity up to 80% of TP.  
Subjects will be instructed to increase stimulation intensity slowly (by one click every two hours) if they 
are not experiencing pain relief. Similarly, intensity should be reduced slowly if they are experiencing 
increased pain, uncomfortable stimulation, heaviness or any other side effects.  
 
Subjects will be provided with a pain diary, instructed to fill it daily and return it at the trial assessment 
visit 1. 
 
The following activities and assessments will be performed during SCS trial: 
 
Timing of visit 
Activities at visit 
Case Report Form 
SCS Trial 
• 
SCS lead implant 
• 
EPG programming 
• 
Collect stimulation parameters 
• 
Provide pain diary 
• 
Surgery Form 
• 
Randomization Form 
• 
Programming Parameters 
Form 
• 
VAS Pain Diary Form 
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 25 of 45 
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6.6 
TRIAL ASSESSMENT 1 
Two weeks after the start of the trial subject will assess therapeutic efficacy of the stimulation delivered 
using the lead assigned by randomization. Subjects will rate their level of pain using the VAS 
assessment, their quality of life using the EQ-5D questionnaire and their disability level using the ODI 
questionnaire.  
Before any change is made, stimulation parameters used in the previous two weeks will be collected. 
Subsequently, subjects will cross over to stimulation delivered using the second lead.  EPG stimulation 
programs used in the previous 2 weeks will be deleted and new stimulation programs will be 
programmed using the procedure detailed in the section 6.5.   
 
Subjects will return the pain diary, be provided with a new one, instructed to fill it daily and return it at 
the trial assessment visit 2. 
 
The following activities and assessments will be performed during end of anatomical lead trial visit: 
 
Timing of visit 
Activities at visit 
Case Report Form 
Trial Assessment 1 • 
Subject assessments of current pain levels, 
quality of life and disability 
• 
Collect stimulation parameters 
• 
 EPG programming 
• 
Collect pain diary 
• 
Provide pain diary 
• 
VAS Form 
• 
EQ-5D 
• 
ODI 
• 
Programming Parameters 
Form 
• 
VAS Pain Diary Form 
 
6.7 
TRIAL ASSESSMENT 2 
At the end of the trial, subject will assess therapeutic efficiency of the stimulation delivered in the 
previous two weeks.  Subjects will rate their level of pain using the VAS assessment, their quality of life 
using the EQ-5D questionnaire, their disability level using the ODI questionnaire and their preference. 
If the improvement in VAS obtained at either of the two trial assessment visits is ≥50% of the baseline 
score, SCS trial will be considered successful and subjects will be considered for permanent IPG 
implant.  Otherwise the subject will exit the study. 
 
The following activities and assessments will be performed during end of anatomical lead trial visit: 
 
Timing of visit 
Activities at visit 
Case Report Form 
Trial Assessment 2 • 
Subject assessments of current pain level, 
quality of life and disability 
• 
Collect stimulation parameters 
• 
Record subject preference between 
stimulation delivered using the 2 leads 
• 
Collect pain diary 
• 
VAS Form 
• 
EQ-5D 
• 
ODI 
• 
Subject Preference Form 
• 
VAS Pain Diary Form 
 
6.8 
SCS IMPLANT PROCEDURE 
IPG will be implanted using standard surgical techniques. 
 
The following activities and assessments will be performed during SCS implant: 
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 26 of 45 
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Timing of visit 
Activities at visit 
Case Report Form 
SCS Implant 
• 
IPG implant 
• 
Surgery Form 
 
6.9 
ACTIVATION VISIT 
The lead activated will depend on the subject’s preference following the trial.  It the subject has no 
preference, the lead placed using the anatomic midline-based technique will be activated. Stimulation 
intensity will be programmed with the same method used in the SCS trial implant visit. 
 
Subjects will be provided a pain diary and instructed to complete it on the last week before the first 
follow up visit. 
 
The following activities and assessments will be performed during activation visit. 
 
Timing of visit 
Activities at visit 
Case Report Form 
Activation 
• 
IPG programming 
• 
Provide pain diary 
• 
Programming Parameters 
form 
 
6.10 
SCHEDULED FOLLOW-UPS 
Subjects will be followed up for 12 months. During each visit, the subjects will rate their level of pain 
using the VAS assessment, their quality of life using the EQ-5D questionnaire and their disability level 
using the ODI questionnaire.  Stimulation parameters used will be collected before any change (if 
necessary) is made. 
 
Subjects will return the pain diary, be provided a new one and instructed to complete it on the last week 
before the following follow up visit. 
 
The following activities and assessments will be performed during follow up visits. 
 
Timing of visit 
Activities at visit 
Case Report Form 
Follow up 
• 
Subject assess current pain levels, quality of 
life and disability 
• 
Collect stimulation parameters 
• 
Collect pain diary 
• 
Provide pain diary 
• 
VAS Form 
• 
EQ-5D Form 
• 
ODI Form 
• 
Programming Parameters 
Form 
• 
VAS Pain Diary Form 
• 
Subject Satisfaction Form 
 
6.11 
UNSCHEDULED VISITS 
An Unscheduled Visit is defined as any visit where an active study subject returns to the participating 
study site for medical care outside of a specified study visit.  Unscheduled visits may include subjects 
returning to the office for an adverse event. 
The visit should be documented by completing the Unscheduled Visit Form and any other applicable 
forms (Adverse Event, Deviation, Death and/or Withdrawal Form). 
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 27 of 45 
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6.12 
DESCRIPTION OF ACTIVITIES PERFORMED BY SPONSOR REPRESENTATIVES 
Trained sponsor personnel may perform certain activities to ensure compliance to the clinical 
investigational plan and may provide technical expertise. 
Sponsor personnel may:  
• 
Provide technical support to the Investigators during trial 
Sponsor personnel will not:  
• 
Perform the informed consent process  
• 
Provide medical diagnosis or treatment to subjects  
• 
Discuss a subject’s condition or treatment with a subject without the approval and presence of a 
health care practitioner  
• 
Independently collect clinical investigational data 
 
6.13 
SUBJECT STUDY COMPLETION 
When the subject’s participation in the clinical study has been completed the subject will return to the 
medical care as per physician’s recommendation. 
 
6.14 
ANY KNOWN OR FORSEEABLE FACTORS THAT MAY COMPROMISE THE OUTCOME OF 
THE CLINICAL STUDY OR THE INTERPRETATION OF THE RESULTS 
All foreseeable factors that may compromise the outcome have been taken into account by clinical 
study design and well-defined subject selection criteria. 
Patient recruitment and retention will be monitored throughout the study and include (but are not limited 
to) the following activities: evaluation of the site and investigators, training of site personnel, developing 
site support materials, providing patient visit calendars.  
6.15 
CRITERIA AND PROCEDURES FOR SUBJECT WITHDRAWAL OR DISCONTINUATION 
Subjects must be informed about their right to withdraw from the study at any time and for any reason 
without sanction, penalty or loss of benefits to which the subject is otherwise entitled and withdrawal 
from the study will not jeopardize their future medical care or relationship with the investigator. Subjects 
will be asked to specify the reason for the termination, but have the right not to answer. 
 
The investigator may decide to withdraw a subject from the study at any time with reasonable rationale. 
The subject’s future care will not be influenced by a decision, voluntary or otherwise, to withdraw from 
the study. All reasonable efforts should be made to retain the subject in the clinical study until 
completion of the study. 
 
Reasons for subject’s withdrawal include, but are not limited to: 
 
• 
Subject refuses to continue participating in the study 
• 
Subject does not meet the inclusion/exclusion criteria and does not require additional follow-up for 
safety reasons. 
• 
Subject is deceased (cause must be documented) 
• 
Subject’s non-compliance 
• 
Subject’s participation is terminated by the PI or investigator, although the subject consented, 
since participation is no longer medically appropriate 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 28 of 45 
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or used without the express written consent of St. Jude Medical 
• 
Subject is ‘lost to follow up’: Subject does not adhere to the scheduled follow up visits but has not 
explicitly requested to be withdrawn from the clinical study. (This does not apply to missed visits). 
Site personnel should at all times make all reasonable efforts to locate and communicate with the 
subject in order to achieve subject compliance to the scheduled follow up visits: 
1.  A subject will be considered ‘Lost to Follow Up’ after a minimum of 2 phone calls of a 
physician or delegate at the investigational site to the subject or contact. These 2 phone calls 
need to be documented in the subject’s hospital records. 
2.  If these attempts are unsuccessful, a letter should be sent to the subject’s last known 
address or general practitioner (GP) and a copy of this letter should be maintained in the 
subject’s hospital records. 
 
Note: If a subject misses one or more of the scheduled follow up visits (inclusive of the assigned visit 
windows), this will be considered as a missed visit. The subject may therefore still return for subsequent 
visits and will not be excluded from the study. 
 
If a subject withdraws from the clinical study, the site will record the subject’s reasons for withdrawal, on 
a Withdrawal CRF. 
 
When subject withdrawal from the clinical study is due to an adverse event the subject will be followed 
until resolution of that adverse event or determination that the subject’s condition is stable. The status 
of the subject’s condition should be documented at the time of withdrawal.   
 
The subject should be seen for a final study visit. At this final study visit, the subject will undergo the 
following evaluations: 
• 
Identify and describe required evaluations or other procedures 
  
7.0 COMPLIANCE TO CIP 
7.1 
STATEMENTS OF COMPLIANCE 
The study will be performed in accordance with the most current versions of the World Medical 
Association (WMA) Declaration of Helsinki, ISO14155 and any regional and/or national regulations and 
will be compliant to this International Standard and any regional and national regulations, as 
appropriate. 
 
The investigator will not start enrolling subjects or requesting informed consent from any subject prior 
to obtaining IRB/EC approval and Competent Authority approval, if applicable, and authorization from 
the sponsor in writing for the study. 
 
In case additional requirements are imposed by the IRB/EC or Competent Authority, those 
requirements will be followed, if appropriate. If any action is taken by an IRB/EC, and regulatory 
requirements with respect to the study, that information will be forwarded to St. Jude Medical. 
 
As sponsor, St. Jude Medical has taken up general liability insurance in accordance with the 
requirements of the applicable local laws. Appropriate country representative will be utilized to 
understand the requirements for the type of insurance that will be provided for subjects, such 
information will be incorporated into the informed consent, as applicable 
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 29 of 45 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed 
or used without the express written consent of St. Jude Medical 
If required, additional subject coverage or a study specific insurance will be provided by the Sponsor as 
well. 
 
7.2 
ADHERENCE TO THE CLINICAL INVESTIGATION PLAN 
A deviation is defined as an event where the clinical investigator, site personnel, sponsor or sponsor 
representative did not conduct the clinical study according to the Clinical Investigational Plan, IRB/EC 
requirements or the Investigator Agreement. The investigator is not allowed to deviate from the CIP, 
except as specified under emergency circumstances.   
 
In some cases, failure to comply with the CIP may be considered failure to protect the rights, safety and 
well-being of subjects, since the non-compliance exposes subjects to unreasonable risks. For example, 
failure to adhere to the inclusion/exclusion criteria: these criteria are specifically defined by the Sponsor 
to exclude subjects for whom the device is not beneficial and the use involves unreasonable risks. This 
may be considered failure to protect the rights, safety and well-being of the enrolled subject. Similarly, 
failure to perform safety assessments intended to detect adverse events may be considered failure to 
protect the rights, safety and well-being of the enrolled subject. Investigators should seek minimization 
of such risks by adhering to the CIP. 
 
Simultaneously, in the event that adhering to the CIP might expose the subject to unreasonable risks, 
the investigator is also required to protect the rights, safety and well-being of the subject by intentionally 
deviating from the requirements of the CIP, so that subjects are not exposed to unreasonable risks.  
 
It is the responsibility of the investigator to provide adequate medical care to a subject enrolled in a 
study. 
 
Regulations require that the PI maintain accurate, complete, and current records, including documents 
showing the date of and reason for every deviation from the Clinical Investigational Plan.  Relevant 
information for each deviation will be documented on a Deviation Case Report Form. The site will 
submit the CRF to St. Jude Medical. 
 
Regulations require Investigators obtain approval from St. Jude Medical and the IRB/EC [as required] 
before initiating changes in or deviations from the protocol, except when necessary to protect the life or 
physical well-being of a subject in an emergency.  Under emergency circumstances, deviations from 
the CIP to protect the rights, safety and well-being of human subjects may proceed without prior 
approval of the sponsor and the EC. Such deviations shall be documented and reported to the sponsor 
and the EC as soon as possible, but no later than 5 working days. 
 
Prior approval must be requested when the PI anticipates, contemplates, or makes a conscious 
decision to depart from the CIP, except when unforeseen circumstances are beyond the investigator’s 
control (e.g. a subject who fails to attend a scheduled follow-up visit, a subject is too ill to perform a 
CIP-required test, etc.).  All deviations, including those beyond the investigator’s control, must be 
reported on a CRF. 
 
To obtain approval, the Principal Investigator may call or email and discuss the potential deviation with 
St. Jude Medical or designee prior to initiating any changes.   
 
All deviations must be reported to appropriate regulatory authorities in specified timelines (if 
appropriate). 
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 30 of 45 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed 
or used without the express written consent of St. Jude Medical 
Investigators or the designee must notify St. Jude Medical, Inc. as soon as possible and complete the 
Deviation CRF. 
 
The Investigator is required to adhere to local regulatory requirements for reporting deviations to 
IRB/EC. 
 
7.3 
REPEATED AND SERIOUS NON-COMPLIANCE 
In the event of repeated non-compliance or a one-time serious non-compliance, as determined by the 
Sponsor, a Clinical Research Associate or clinical representative will attempt to secure compliance by 
one or more of the following actions: 
• 
Visiting the investigator 
• 
Contacting the investigator by telephone 
• 
Contacting the investigator in writing 
• 
Retraining of the investigator 
 
If an investigator is found to be repeatedly non-compliant with the signed agreement, the CIP or any 
other conditions of the clinical study, the Sponsor will either secure compliance or, at its sole discretion, 
terminate the investigator’s participation in the clinical study. 
 
8.0 ADVERSE EVENT, ADVERSE DEVICE EFFECT, DEVICE DEFICIENCY 
8.1 
DEFINITIONS 
8.1.1 
Medical device 
Any instrument, apparatus, implement, machine, appliance, implant, software, material or other similar 
or related article 
• 
Intended by the manufacturer to be used, alone or in combination, for human beings for one or 
more of the specific purpose(s) of 
o Diagnosis, prevention, monitoring, treatments or alleviation of disease, 
o Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury, 
o Investigation, replacement, modification, or support of the anatomy or of a physiological 
process, 
o Supporting or sustaining life, 
o Control of conception, 
o Disinfection of medical devices and 
• 
Which does not achieve its primary intended action in or on the human body by pharmacological, 
immunological or metabolic means, but which may be assisted in its intended function by such 
means 
 
8.1.2 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including 
abnormal laboratory findings) in subjects, users or other persons, whether or not related to the 
investigational medical device under study. 
 
This definition includes events related to the investigational medical device or the comparator. 
This definition includes events related to the procedures involved. 
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 31 of 45 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed 
or used without the express written consent of St. Jude Medical 
8.1.3 
Serious Adverse Event (SAE) 
An adverse event that led to: 
• 
Death 
• 
A serious deterioration in the health of the subject, that either resulted in: 
o A life-threatening illness or injury OR 
o A permanent impairment to a body structure or a body function OR 
o An in-patient or prolonged hospitalization OR 
o A medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body OR 
o A malignant tumor 
• 
Fetal distress, fetal death or a congenital abnormality or birth defect 
A planned hospitalization for a pre-existing condition, or a procedure required by the CIP is not 
considered a serious adverse event. 
 
8.1.4 
Adverse Device Effect (ADE) 
An adverse event related to the use of an investigational medical device. 
 
This definition includes adverse events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the investigational medical 
device. 
 
This definition includes any event resulting from the use error or from intentional misuse of the 
investigational medical device. 
 
8.1.5 
Serious Adverse Device Effect (SADE) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse 
event. 
 
1. Unanticipated Serious Adverse Device Effect (USADE) [applicable to studies following ISO 
14155] 
A serious adverse device effect which by its nature, incidence, severity or outcome has not been 
identified in the current version of the risk analysis report. 
2. UADE [applicable to investigational studies following FDA regulations] 
As defined in 21 CFR §812.3, unanticipated adverse device effects (UADE) 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 clinical 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.   
 
If an unanticipated adverse device effect occurs, the investigator must notify St. Jude Medical and the 
IRB/MEC immediately, but no later than 10 working days of the investigator’s knowledge of the event, 
as required by 21 CFR §812.150. St. Jude Medical will take any steps necessary to investigate the 
event, and will be responsible for notifying FDA and all other participating IRBs/MECs and 
investigators. 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 32 of 45 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed 
or used without the express written consent of St. Jude Medical 
 
3. Anticipated Serious Adverse Device Effect (ASADE)  
A serious adverse device effect which by its nature, incidence, severity or outcome has been previously 
identified in the risk analysis report. 
 
8.2 
PROCEDURE FOR ASSESSING, RECORDING, AND REPORTING ADVERSE EVENTS, 
DEVICE DEFICIENCIES/COMPLAINTS, ADVERSE DEVICE EFFECTS, SERIOUS ADVERSE 
EVENTS, AND SERIOUS ADVERSE DEVICE EFFECTS:  
Safety surveillance within this study and the safety reporting both performed by the investigator, starts 
as soon as the subject is enrolled in this study (date of signature of the informed consent). The safety 
surveillance and the safety reporting will continue until the last investigational visit has been performed, 
the subject is deceased, the subject/investigator concludes his participation into the study or the 
subject/investigator withdraws the subject from the study, except as otherwise specified in the CIP. 
 
All adverse event data including deaths and device deficiency data (if applicable) will be collected 
throughout the clinical study and will be reported to the Sponsor on a dedicated case report form. The 
Investigator will record all adverse events and device deficiencies on the appropriate case report forms.  
 
Records relating to the subject’s subsequent medical course must be maintained and submitted (as 
applicable) to the Sponsor until the event has subsided or, in case of permanent impairment, until the 
event stabilizes and the overall clinical outcome has been ascertained. Adverse events will be 
monitored until they are adequately resolved.  The status of the subject’s condition should be 
documented at each visit.   
 
The investigator will report the event to the IRB/EC per their reporting requirements.  
 
Reportable events to sponsor are considered: 
• 
All Adverse Device Effects 
• 
All Serious Adverse Events (whether or not the event is considered device or procedure related 
and regardless the randomization group) 
 
All above events will be reported to the Sponsor, as soon as possible, but no later than 72 hours of first 
learning of the event. 
 
The Sponsor will ensure that all events and device deficiencies are reported to the relevant authorities 
as per regulations.  
 
Adverse events needs to be reported using the adverse events CRF specifying date of the adverse 
event, treatment, resolution, assessment of both the seriousness and the relationship to the 
investigational device, type of treatment and status of the adverse event. 
 
Additional information may be requested, when required, by the Sponsor in order to support the 
reporting of AEs to regulatory authorities. 
 
The investigator must notify the IRB/EC, if appropriate, in accordance with national and local laws and 
regulations, of the AEs reported to the Sponsor. 
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 33 of 45 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed 
or used without the express written consent of St. Jude Medical 
 
All adverse events will be reported as per applicable regulatory requirements.  
 
8.3 
SUBJECT DEATH 
8.3.1 
Procedure for recording and reporting subject death 
All subject deaths are to be documented and reported to the sponsor within 72 hours after becoming 
aware of the event. 
 
In event of subject’s death a death and a withdrawal form should be completed.  Deaths should be 
classified according to primary cause (cardiac, non-cardiac, unknown) and relationship to the protocol 
and or device.  Adverse event form should be completed if appropriate. 
 
9.0 DATA MANAGEMENT 
Overall, the Sponsor will be responsible for the data handling. 
 
The sponsor and/or its affiliates will be responsible for compiling and submitting all required reports to 
governmental agencies. 
 
Data will be analyzed by the Sponsor and may be transferred to the Sponsor’s locations outside of 
Europe and/or any other worldwide regulatory authority in support of a market-approval application. 
 
St. Jude Medical respects and protects personally identifiable information that we collect or maintain. 
As part of our commitment, St. Jude Medical is certified to the U.S. - European Union Framework and 
U.S. – Swiss Safe Harbor Framework Agreements regarding human resources and subject clinical trial 
personal information. The privacy of each subject and confidentiality of his/her information will be 
preserved in reports and when publishing any data. Confidentiality of data will be observed by all 
parties involved at all times throughout the clinical study.  All data will be secured against unauthorized 
access. 
 
The following documents will be produced and maintained as part of this study: 
• 
Informed consent form 
• 
CRFs 
 
The Principal Investigator or institution will provide direct access to source data during and after the 
clinical study for monitoring, audits, IRB/EC review and regulatory authority inspections.  As required, 
the Principal Investigator or institution will obtain permission for direct access to source documents from 
the subject, hospital administration and national regulatory authorities before starting the clinical study. 
 
9.1 
DATA MANAGEMENT PLAN 
A detailed Data Management Plan will be established to ensure consistency of the data. This document 
will include procedures used for data review, database cleaning, and issuing and resolving data 
queries. If appropriate, the DMP may be updated throughout the study duration. All revisions will be 
tracked and document controlled. 
 
CRF data will be captured in a validated electronic database management system hosted by St. Jude 
Medical.  

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 34 of 45 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed 
or used without the express written consent of St. Jude Medical 
 
All CRF received data for the study will be entered by trained and qualified St. Jude Medical personnel. 
An electronic audit trail will be used to track any subsequent changes of the entered data. 
 
9.2 
DOCUMENT AND DATA CONTROL 
9.2.1 
Traceability of documents and data 
The investigator will ensure accuracy, completeness, legibility and timeliness of the data reported to the 
sponsor on the CRFs and in all required reports.  
 
9.2.2 
Recording data 
Source documents will be created and maintained by the investigational site team throughout the 
clinical study. 
 
The data reported on the CRFs will be derived from, and be consistent with, these source documents, 
and any discrepancies will be explained in writing. 
 
The following data can be recorded directly in the CRFs: 
• 
Pain VAS scores 
• 
EQ-5D scores 
• 
ODI scores 
 
The CRFs will be signed and dated by the authorized site personnel. Any change or correction to data 
reported on a paper CRF will be dated, initialed and explained if necessary, and will not obscure the 
original entry. 
 
10.0 MONITORING  
It is the responsibility of St. Jude Medical as the sponsor of the study to ensure the study is conducted, 
recorded, and reported according to the approved protocol, subsequent amendment(s), applicable 
regulations, and guidance documents. Monitoring will be conducted according to the St. Jude Medical 
Clinical Monitoring standard operating procedure. 
 
Prior to beginning the study, St. Jude Medical will contact the investigator or designee to discuss the 
study and data requirements. A St. Jude Medical monitor will periodically review the subject records 
and associated source documents.  
 
The investigator shall make subject and study records available to the clinical monitor for monitoring. 
  
11.0 REGULATORY INSPECTIONS 
The investigator and/or delegate should contact St. Jude Medical immediately upon notification of a 
governmental agency inspection at the site. A clinical monitor or designee will assist the investigator 
and/or delegate in preparing for the audit. 
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 35 of 45 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed 
or used without the express written consent of St. Jude Medical 
An investigator who has authority to grant access will permit authorized governmental agency 
employees, at reasonable times and in reasonable manner, to enter and inspect any establishment 
where devices are held (including any establishment where devices are used or where records or 
results are kept). 
 
An investigator, or any person acting on behalf of such a person with respect to the study, will permit 
authorized governmental agency employees, at reasonable times and in reasonable manner, to inspect 
and copy all records relating to the study. 
 
An investigator will permit authorized governmental agency employees to inspect and copy records 
that identify subjects, upon notice that governmental agency has reason to suspect that adequate 
informed consent was not obtained, or that reports required to be submitted by the investigator, to the 
Sponsor or IRB/EC have not been submitted or are incomplete, inaccurate, false or misleading. 
 
12.0 STATISTICAL CONSIDERATIONS 
12.1 
STATISTICAL DESIGN, HYPOTHESES, METHOD AND ANALYTICAL PROCEDURES 
VAS scores, EQ-5D scores and ODI scores will be tested for statistical differences using a repeated 
measures ANOVA . 
 
12.2 
SAMPLE SIZE 
Approximately 50 patients will be enrolled in this study.  Based on clinical experience atleast 80% of the 
subjects are expected to have a successful trial and be implanted with permanent IPGs. Enrollment will 
be discontinued after 40 subjects have received a permanent implant. This study is a feasibility trial; the 
sample power cannot be calculated because the effect size is not known.  The sample size was 
selected to obtain early evidence and estimates of the effect size.  
 
12.3 
PASS/FAIL CRITERIA TO BE APPLIED TO THE RESULTS OF THE CLINICAL STUDY 
The trial will be considered successful if significant pain relief can be obtained using burst stimulation in 
leads implanted using anatomical midline-based lead positioning. 
 
13.0 DOCUMENT RETENTION 
The principal investigator (PI) will maintain all clinical study documents from prior, during and (as 
specified) after the clinical study on file at the site for a minimum of 15 years after the termination of this 
study, or longer as per local laws, or when it is no longer needed to support a marketing application, 
whichever is later.   
The PI must contact the sponsor prior to destroying or archiving off-site any records and reports 
pertaining to this study to ensure that they no longer need to be retained on-site. 
All original subject files must be stored for the longest possible time permitted by the regulations at the 
hospital, research institute, or practice in question. If archiving can no longer be maintained at the site, 
the investigator will notify the sponsor.  
 
All data and documents will be made available on request of the relevant authorities in case of an audit. 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 36 of 45 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed 
or used without the express written consent of St. Jude Medical 
 
The sponsor will archive and retain all essential clinical study documents from prior, during and (as 
specified) after the clinical study as per requirements.  
 
These documents must be retained by the investigational site for a period of 2 years after clinical study 
conclusion and made available for monitoring or auditing by St. Jude Medical’s representative or 
representatives of the FDA and other applicable regulatory agencies.  The Principal Investigator must 
ensure the availability of source documents from which the information on the case report forms was 
derived. 
14.0 AMENDMENTS TO CLINICAL INVESTIGATIONAL PLAN 
Study related documents such as, the Investigator Brochure (IB), Report of Prior Investigations (RPI) 
CIP, CRFs, Informed Consent form and other subject information, or other clinical study documents will 
be amended as needed throughout the clinical study, and a justification statement will be included with 
each amended section of a document. Proposed amendments to the CIP will be agreed upon between 
the Sponsor and the coordinating investigator (if applicable).  
 
The amendments to the CIP and the subject’s Informed Consent will be notified to, or approved by, the 
IRB/EC and regulatory authorities, if required. The version number and date of amendments will be 
documented. 
 
The amendment will identify the changes made, the reason for the changes and if it is mandatory or 
optional to implement the amendment. 
 
Any amendment affecting the subject requires that the subject be informed of the changes and a new 
consent be signed and dated by the investigator at the subject’s next follow up. 
 
Changes to, or formal clarifications of, the CIP will be documented in writing and provided to the 
investigators. This information will be incorporated when an amendment occurs. 
 
15.0 INVESTIGATION SUSPENSION OR TERMINATION 
15.1 
PREMATURE TERMINATION OF THE WHOLE CLINICAL STUDY OR OF THE CLINICAL 
STUDY IN ONE OR MORE INVESTIGATIONAL SITES 
The Sponsor reserves the right to stop the study at any stage, with appropriate written notice to the 
investigator.  
 
Possible reasons for early termination of the study by the sponsor, either at local, national or 
international level, may include, but are not limited to: 
 
• 
The device /  therapy fails to perform as intended 
• 
Occurrence of USADE which cannot be prevented in future cases 
• 
Sponsor’s decision 
• 
Recommendation from DSMB to Steering committee and Sponsor 
• 
Request from Regulatory bodies 
• 
Request of Ethics Committee(s)  

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 37 of 45 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed 
or used without the express written consent of St. Jude Medical 
• 
Concern for subject safety and welfare 
• 
Failure to secure subject Informed Consent prior to any investigational activity 
• 
Failure to report unanticipated adverse device effects within 72 hours to St. Jude Medical and the 
EC 
• 
Repeated non-compliance with this CIP or the Clinical Trial Agreement 
• 
Inability to successfully implement this CIP 
• 
Violation of the Declaration of Helsinki 2008 (refer to Appendix C) 
• 
Violation of applicable national or local laws and regulations 
• 
Falsification of data, or any other breach of ethics or scientific principles 
• 
Loss of or unaccounted use of investigational device inventory 
 
 
The study will be terminated according to applicable regulations. 
 
The investigator may also discontinue participation in the clinical study with appropriate written notice to 
the Sponsor. 
 
Should either of these events occur, the investigator will return all documents to the sponsor; provide a 
written statement as to why the premature termination has taken place and notify the IRB/EC and/or the 
Competent Authority (if applicable). Follow-up for all enrolled subjects will be as per CIP requirements. 
 
A Principal Investigator, IRB/EC or regulatory authority may suspend or prematurely terminate 
participation in a clinical study at the investigational sites for which they are responsible.   
 
If suspicion of an unacceptable risk to subjects arises during the clinical study or when so instructed by 
the IRB/EC or regulatory authority, St. Jude Medical may suspend the clinical study as appropriate 
while the risk is assessed.  St. Jude Medical will terminate the clinical study if an unacceptable risk is 
confirmed.   
 
St. Jude Medical will consider terminating or suspending the participation of a particular investigational 
site or investigator in the clinical study if monitoring or auditing identifies serious or repeated deviations 
on the part of an investigator.   
 
If suspension or premature termination occurs, the terminating party will justify its decision in writing 
and promptly inform the other parties with whom they are in direct communication.  The Principal 
Investigator and St. Jude Medical will keep each other informed of any communication received from 
IRB/EC or regulatory authority.   
 
If for any reason St. Jude Medical suspends or prematurely terminates the study at an individual 
investigational site, St. Jude Medical will inform the responsible regulatory authority, as appropriate, 
and ensure that the IRB/EC are notified, either by the Principal Investigator or by St. Jude Medical.  If 
the suspension or premature termination was in the interest of safety, St. Jude Medical will inform all 
other Principal Investigators.   
 
If suspension or premature termination occurs, St. Jude Medical will remain responsible for providing 
resources to fulfill the obligations from the CIP and existing agreements for following up the subjects 
enrolled in the clinical study, and the Principal Investigator or authorized designee will promptly inform 
the enrolled subjects at his/her investigational site, if appropriate.   
 
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 38 of 45 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed 
or used without the express written consent of St. Jude Medical 
15.2 
RESUMING THE STUDY AFTER TEMPORARY SUSPENSION 
When St. Jude Medical concludes an analysis of the reasons for the suspension, implements the 
necessary corrective actions, and decides to lift the temporary suspension, St. Jude Medical will inform 
the Principal Investigators, IRB/EC, or regulatory authority, where appropriate, of the rationale, 
providing them with the relevant data supporting this decision.   
 
Concurrence will be obtained before the clinical study resumes from the IRB/EC or regulatory authority 
where appropriate.   
 
If subjects have been informed of the suspension, the Principal Investigator or authorized designee will 
inform them of the reasons for resumption. 
 
15.3 
STUDY CONCLUSION 
The study will be concluded when: 
• 
All sites are closed AND 
• 
The Final report generated by St. Jude Medical has been provided to sites or St. Jude Medical 
has provided formal documentation of study closure 
 
16.0 PUBLICATION POLICY 
The results of the clinical study may be submitted for publication.  
 
A ‘Publication Agreement’ will be signed between the Principal Investigator and the Sponsor either as a 
separate Publication Agreement or within the Clinical Trial Agreement. 
 
For more information on publication guidelines, please refer to the International Committee of Medical 
Journal Editors (ICMJE) on www.icmje.org. 
 
17.0 BIBLIOGRAPHY  
Al-Kaisy A, Van Buyten JP, Smet I, Palmisani S, Pang D, Smith T. Sustained effectiveness of 10 kHz 
high-frequency spinal cord stimulation for patients with chronic, low back pain: 24-month results of a 
prospective multicenter study. Pain Med. 2014 Mar;15(3):347-54. 
 
Courtney P, Espinet A, Mitchell B, Russo M, Muir A, Verrills P, Davis K.  Improved Pain Relief With 
Burst Spinal Cord Stimulation for Two Weeks in Patients Using Tonic Stimulation: Results From a 
Small Clinical Study.  Neuromodulation. 2015 Jul;18(5):361-6. 
de Vos CC, Bom MJ, Vanneste S, Lenders MW, de Ridder D. Burst spinal cord stimulation evaluated in 
patients with failed back surgery syndrome and painful diabetic neuropathy. Neuromodulation. 2014 
Feb;17(2):152-9. 
Schu S, Slotty PJ, Bara G, von Knop M, Edgar D, Vesper J. A prospective, randomised, double-blind, 
placebo-controlled study to examine the effectiveness of burst spinal cord stimulation patterns for the 
treatment of failed back surgery syndrome. Neuromodulation. 2014 Jul;17(5):443-50. 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 39 of 45 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed 
or used without the express written consent of St. Jude Medical 
Taylor RS. Spinal cord stimulation in complex regional pain syndrome and refractory neuropathic back 
and leg pain/failed back surgery syndrome: results of a systematic review and meta-analysis.  J Pain 
Symptom Manage.  2006 Apr;31(4 Suppl):S13-9.  Review 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 40 of 45 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed 
or used without the express written consent of St. Jude Medical 
 
APPENDIX A: ABBREVIATIONS 
 
Select or add abbreviations used 
Abbreviation 
Term 
ADE 
AE 
ASADE 
CA 
CCI 
CEC 
CIP 
CRF 
CPRB 
DD 
DMP 
DSMB 
EC 
eCRF 
EDC 
EMEA 
EPG 
EQ-5D 
GP 
IB 
ICMJE 
IPG 
IRB 
ISB 
ISO 
MP 
NA 
ODI 
PI 
POA 
RDC 
SADE 
SAE 
SC  
SCS 
SJM 
USADE 
VAS 
WMA 
Adverse Device Effect 
Adverse Event 
Anticipated Serious Adverse Device Effect 
Competent Authority 
Clinical Coordination Investigator 
Clinical Events Committee 
Clinical Investigational Plan 
Case Report Form 
Clinical Project Review Board 
Device Deficiency 
Data Management Plan 
Data Safety Monitoring Board  
Ethics Committee 
Electronic Case Report Form 
Electronic Data Capture 
Europe, Middle East, Africa 
External Pulse Generator 
European Quality of life questionnaire 5 dimensions 
General Practitioner 
Investigator Brochure 
International Committee of Medical Journal Editors 
Implantable Pulse Generator 
Institutional Review Board 
Investigator Site Binder 
International Organization for Standardization 
Monitoring Plan 
Not Applicable 
Oswestry Disability Index 
Principal Investigator 
Power of Attorney 
Remote Data Capture 
Serious Adverse Device Effect 
Serious Adverse Event 
Steering Committee 
Spinal Cord Stimulation 
St. Jude Medical 
Unanticipated Serious Adverse Device Effect 
Visual analog scale 
World Medical Association 
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 41 of 45 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed 
or used without the express written consent of St. Jude Medical 
 
APPENDIX B: CIP REVISION HISTORY 
 
Revision History 
Amendment 
Number 
Version 
Date 
Rationale 
Details 
Not 
Applicable 
VA 
ddMMMyyyy 
First release of CIP 
NA 
 
 
 
 
 
 
 
 
 
 
 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 42 of 45 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed 
or used without the express written consent of St. Jude Medical 
 
Appendix C: DECLARATION OF HELSINKI 
The most current version of the document will be followed. 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 43 of 45 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed 
or used without the express written consent of St. Jude Medical 
 
Appendix D: LIST OF CLINICAL INVESTIGATION SITES AND IRB/EC 
A list of Clinical Investigational sites and IRB/EC will be kept under a separate cover and is available 
upon request.  

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 44 of 45 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed 
or used without the express written consent of St. Jude Medical 
 
Appendix E: SAMPLE INFORMED CONSENT 
Study specific informed consent will be kept under a separate cover and is available upon request 

Study Document No: SJM-CIP-10126 Ver. A 
Study Name: CRISP 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 45 of 45 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed 
or used without the express written consent of St. Jude Medical 
 
Appendix F: CASE REPORT FORMS 
Case report forms will be kept under a separate cover and are available upon request.