Objective Assessment of Activity and Sleep Quality In Burst Spinal Cord Stimulation
Phase: NA
Conditions: Chronic Pain
Sponsor: Abbott Medical Devices

COVER PAGE 
 
 
Study title: 
Objective Assessment of Activity and Sleep Quality In Burst Spinal Cord Stimulation 
(OASIS) 
 
NCT number: 
NCT02950831 
 
Document Date: 
05-05-2016 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
Reference:  
SJM-CIP-10133 
 
OASIS 
“Objective assessment of Activity and Sleep quality In burst spinal cord Stimulation” 
Clinical Investigation Plan (CIP) 
 
Sponsor  
 
 
St. Jude Medical, Inc. 
6901 Preston Road 
Plano, TX  75024 
USA 
Tel: 972 309 8000 
Fax:  972 309 8150 
 
 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
PRINICPAL INVESTIGATOR SIGNATURE PAGE 
OASIS 
 
Objective assessment of Activity and Sleep quality In burst spinal cord Stimulation 
 
 
Version A 
Reference #: SJM-CIP-10133 
 
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-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
Table Of Contents 
Page 
 
Synopsis ....................................................................................................................................... 5 
1.1 Study Flow Chart ................................................................................................................................................. 9 
1.2 Study Contacts...................................................................................................................................................... 9 
 
Background And Justification For Clinical Study .......................................................................... 10 
 
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 
 
Study Design ............................................................................................................................... 14 
4.1 Purpose ............................................................................................................................................................... 14 
4.2 Study Design And Scope .................................................................................................................................... 14 
4.3 Objectives ........................................................................................................................................................... 15 
4.4 Endpoints ............................................................................................................................................................ 15 
4.5 Inclusion And Exclusion Criteria ....................................................................................................................... 16 
4.6 Subject Population .............................................................................................................................................. 18 
4.7 Informed Consent Process .................................................................................................................................. 18 
 
Device Under Investigation And Control/Comparators (If Applicable) .......................................... 19 
5.1 Device Description ............................................................................................................................................. 19 
5.2 Device Accountability (If Applicable) ............................................................................................................... 20 
 
Procedures .................................................................................................................................. 21 
6.1 Study Flow Chart ............................................................................................................................................... 21 
6.2 Procedures .......................................................................................................................................................... 22 
6.3 Enrollment .......................................................................................................................................................... 22 
6.4 Baseline Visit ..................................................................................................................................................... 23 
6.5 Scs Trial ............................................................................................................................................................. 24 
6.6 End Of Trial Visit ............................................................................................................................................... 24 
6.7 Permanent Implant ............................................................................................................................................. 25 
6.8 Activation Visit .................................................................................................................................................. 25 
6.9 Scheduled Follow-Ups ....................................................................................................................................... 25 
6.10 Unscheduled Visits ............................................................................................................................................. 25 
6.11 Description Of Activities Performed By Sponsor Representatives .................................................................... 26 
6.12 Subject Study Completion .................................................................................................................................. 26 
6.13 Any Known Or Forseeable Factors That May Compromise The Outcome Of The Clinical Study Or The 
Interpretation Of The Results ...................................................................................................................................... 26 
6.14 Criteria And Procedures For Subject Withdrawal Or Discontinuation .............................................................. 26 
 
Compliance To Cip ...................................................................................................................... 27 
7.1 Statements Of Compliance ................................................................................................................................. 27 
7.2 Adherence To The Clinical Investigation Plan ................................................................................................... 28 
7.3 Repeated And Serious Non-Compliance ............................................................................................................ 29 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
 
Adverse Event, Adverse Device Effect, Device Deficiency .......................................................... 29 
8.1 Definitions .......................................................................................................................................................... 29 
8.2 Procedure For Assessing, Recording, And Reporting Adverse Events, Device Deficiencies/Complaints, 
Adverse Device Effects, Serious Adverse Events, And Serious Adverse Device Effects: ......................................... 31 
8.3 Subject Death ..................................................................................................................................................... 32 
8.4 Device Deficiency (Dd)...................................................................................................................................... 32 
 
Data Management ....................................................................................................................... 33 
9.1 Data Management Plan ...................................................................................................................................... 33 
9.2 Document And Data Control .............................................................................................................................. 34 
 Monitoring ................................................................................................................................... 34 
 Regulatory Inspections ................................................................................................................ 34 
 Statistical Considerations ............................................................................................................ 35 
12.1 Statistical Design, Hypotheses, Method And Analytical Procedures ................................................................. 35 
12.2 Sample Size ........................................................................................................................................................ 35 
 Document Retention .................................................................................................................... 35 
 Amendments To Clinical Investigational Plan .............................................................................. 35 
 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 ........................................................................................... 37 
15.3 Study Conclusion ............................................................................................................................................... 37 
 Publication Policy ........................................................................................................................ 38 
 Bibliography ................................................................................................................................ 38 
Appendix A: Abbreviations ................................................................................................................... 39 
Appendix B: Cip Revision History ......................................................................................................... 40 
Appendix C: Declaration Of Helsinki .................................................................................................... 41 
Appendix D: List Of Clinical Investigation Sites And Irb/Ec ................................................................... 42 
Appendix E: Sample Informed Consent ............................................................................................... 43 
Appendix F: Case Report Forms .......................................................................................................... 44 
 
 
 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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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 
 SYNOPSIS  
 
Title: 
Objective assessment of activity and sleep quality in burst SCS 
Acronym: 
OASIS 
Purpose: 
The purpose of this study is to assess feasibility of using wearable sensors 
to capture objective assessments of patient’s activity and sleep quality 
during the spinal cord stimulation (SCS) treatment continuum.  
Primary Objective: 
To compare objective assessments of activity levels and sleep quality 
prior to trial, during trial and after permanent implant in failed back 
surgery syndrome or chronic intractable pain patients who are eligible for 
a SCS trial 
Secondary 
Objectives: 
To compare objective assessments obtained with wearable sensors to 
subjective assessments of: 
• Pain; 
• Quality of life; 
• Disability 
obtained using patients questionnaires  
Primary Endpoint: 
• Change in activity levels and sleep quality between baseline, SCS trial 
and 1, 2 and 3 months following permanent implant  
Secondary 
Endpoints: 
• Compare changes in activity assessed using wearable sensors to 
changes in visual analog scale (VAS) pain scores, quality of life, and 
disability scores assessed using patient questionnaires 
• Compare changes in sleep quality assessed using wearable sensors to 
changes in visual analog scale (VAS) pain scores, quality of life, and 
disability scores assessed using patient questionnaires 
between baseline, SCS trial and 1, 2 and 3 months following permanent 
implant  
Design: 
This is a prospective, multicenter, single arm, observational study 
designed to evaluate feasibility of using wearable sensors to capture 
objective assessments of patient’s activity and sleep quality during SCS 
treatment continuum. 
 
Subjects with a diagnosis of failed back surgery syndrome or chronic 
intractable trunk and lower limb pain and eligible for a SCS trial will be 
considered for inclusion in the study.  After screening for eligibility using 
the inclusion/exclusion criteria, baseline evaluation will be performed.  
Eligible subjects will be provided with wearable sensors in order to record 
objective activity and sleep quality assessments for 2 weeks and a one-
week pain diary to be completed in the last week of the baseline 
evaluation. 
 
Subjects will subsequently be trialed using St. Jude Medical (SJM) 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
invisible trial system according to standard clinical procedures.  During 
the trial, objective assessments will be recorded using the wearable 
sensors and pain will be recorded using a pain diary in the last week of the 
trial.  Subjective assessments will be performed at the end of the trial. 
 
Subjects attaining at least 50% low back and lower limbs pain relief 
(assessed using the VAS questionnaire) will be eligible for permanent 
implant and further participation in the study. 
 
After activation of the permanent implant, subjects will be followed up for 
3 months.  Objective assessments will be recorded using the wearable 
sensor throughout the 3 month duration and pain recorded using pain 
diaries in the week before follow up visits. Subjective assessments will be 
performed during the 1, 2 and 3 month follow up visits.  Subjects w 
 
The total duration of the study is expected to be 12 months. 
 
The clinical study will be conducted in three centers in the EMEA region  
 
Approximately 20 subjects will be enrolled in this study. 
Devices used: 
• SJM Invisible trial system 
• SJM SCS leads and extensions 
• Proclaim, Prodigy or Prodigy MRI™ Implantable Pulse Generator 
(IPG)  
• Clinician Programmer  
• Patient Programmer 
• 
Actigraph GT9X link activity monitor  
Study Population 
A patient becomes a subject once he/she has been fully informed about 
the study, has agreed to participate, signed & dated the consent.  
 
The study population consists of patients with a diagnosis of failed back 
surgery syndrome or chronic intractable trunk and lower limb pain and 
who are eligible for a SCS trial.  Patients will be considered for 
enrollment by the Principal Investigator as a candidate for the study at the 
study site if they meet the inclusion/exclusion criteria requirements, and 
agree to participate in the 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; 
• Subjects with the diagnosis of failed back surgery syndrome or 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
chronic intractable trunk and lower limb pain and are eligible for a 
SCS trial;  
• Subjects have an average trunk pain VAS score of at least 6.0 out of 
10.0, and lower limb pain VAS score of at least 6.0 out of 10.0; 
• Subject is on  stable pain medications, as determined by the 
Investigator, 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; 
• Subject agrees to wear the wearable sensor for the duration of  the 
study; 
• 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 
Exclusion Criteria 
• 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 diagnosed with neurological deficits affecting the lower limbs; 
• Subject diagnosed with fibromyalgia or chronic fatigue; 
• 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; 
• Subjects with concurrent clinically significant or disabling chronic 
pain problem that requires additional treatment;  
• 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; 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
• 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 
Screening visit: 
Subjects will be screened as per inclusion/exclusion criteria and will 
complete questionnaires to collect secondary outcome measures before 
the SCS trial.  Specifically assessments will include: pain as assessed by 
the VAS, quality of life as assessed by the EQ-5D, and disability as 
assessed by the Oswestry Disability Index.  Subjects will be provided with 
a wearable accelerometer for a two weeks to collect baseline objective 
assessment of activity levels and sleep quality as well as a one-week pain 
diary to be completed in the last week before initiation of the SCS trial. 
 
Trial phase: 
Subjects will undergo a SCS trial performed according to standard clinical 
practice.  During the trial period the subjects will continue to wear the 
wearable accelerometers and will be asked to complete a one-week pain 
diary during the last week of the trial.  During the end of trial visit, 
subjects will complete questionnaires to collect secondary outcome 
measures as during the screening visit.  Subjects experiencing at least 
50% reduction in VAS scores in their primary area of pain will be 
considered for a permanent SJM SCS neurostimulation implant capable of 
delivering burst stimulation. 
 
Permanent implant procedure: 
Subjects who underwent a successful trial phase will be implanted with an 
implantable pulse generator following standard surgical procedures. 
   
Follow up visits: 
Following permanent implant activation, the subjects will be followed up 
for 3 months.  During the follow up phase of the study, the subjects will 
continuously wear the wearable sensors and complete one-week pain 
diaries in the last week before each follow up visit.  Follow up 
assessments will be performed 1, 2 and 3 months post permanent implant.  
During each of the follow up visits, subjects will complete questionnaires 
to collect secondary outcome measures as during the screening visit. 
 
 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
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-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
 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.  
 
The International Association for the Study of Pain defines pain as “an unpleasant sensory and 
emotional experience associated with actual or potential tissue damage, or described in terms of 
such damage” (derived from Bonica, 1979). It is a complex phenomenon incorporating an 
affective component meant to orient behavior toward avoidance of painful stimuli.  The nature of 
this emotional experience confines pain measurements to strictly subjective evaluations such as 
the visual analog scale (VAS) which is currently accepted as the golden standard.  While this 
form of assessment provides viable evaluations, it remains prone to large inter-user variability 
and is affected from a variety of factors. The perception of, expression of, and reaction to pain 
are influenced by genetic, developmental, familial, psychological, social and cultural variables. 
Psychological factors, such as the situational and emotional factors that exist when we 
experience pain, can profoundly alter the strength of these perceptions. Similarly, attention, 
understanding, control, expectations, and the aversive significance can affect pain perceptions 
(McGrath 1994).  The use of objective, continuous measurements of pain has the potential to 
reduce confounding factors in the evaluation of the therapeutic outcome of SCS and to provide 
feedback to help physicians in the adjustment of pain management strategies.   
 
While considerable efforts toward establishing biomarkers of pain have been performed, no 
established practical method to objectively measure the sensation of pain has been proposed so 
far. Nevertheless, studies in the literature suggest that measurements of behaviors affected by 
pain could be used to indirectly derive information about a person in a painful state.  In a 
nationally representative sample, adults with chronic widespread pain have lower average 
activity and spend less time engaged in moderate to vigorous activity when compared to those 
who do not suffer from chronic pain (Dainese et al. 2014). In patients with chronic pain, mean 
and peak activity levels were lower while sedentary time was longer (Wilson et al. 2012).  
Similarly, sleep disturbances are a known comorbidity of chronic pain (Emery et al. 2014).  SCS 
has the potential to restore physical activity as shown in animal models (Sato et al. 2014, Gong et 
al. 2014).  Likewise SCS produced improvement in insomnia scores (Ramineni et al 2016)) and 
sleep quality (Obuchi et al. 2015).  
Similar to subjective pain evaluations, scales utilized for subjective assessments of activity and 
sleep are limited in their reliability.  A systematic review of 120 physical activity questionnaires 
concluded their validity is “moderate at best” (Helmerhorst et al 2012).  While sleep 
questionnaires can have a higher validity (Nascimento-Ferreira et al 2015) a systematic review of 
the Epworth sleepiness scale does not suggests the use for individual-level comparisons. 
 
Recent advancements in wearable technologies can allow continuous objective assessment of 
changes in patient activity levels and sleep quality, which could be related to effectiveness of 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
pain treatment and management.  In this study, we aim to evaluate the feasibility of using 
wearable sensors to record objective assessments of activity and sleep quality over the duration 
of the SCS treatment continuum.  Additionally we also aim to compare these assessments to the 
commonly used subjective measures in the standard of care in chronic pain patients indicated for 
a SCS trial.  While these objective assessments are not direct measurements of pain, they have 
the potential to serve as a highly accurate tool to evaluate changes in the quality of life and the 
level of disability in chronic pain patients. 
 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
  RISKS AND BENEFITS OF THE CLINICAL STUDY 
The purpose of study is to collect data necessary to evaluate the feasibility of using wearable 
sensors to capture objective measures of patient’s activity and sleep quality during spinal cord 
stimulation (SCS) treatment continuum using burst stimulation.  The study population consists of 
patients with a diagnosis of failed back surgery syndrome or chronic intractable pain who are 
eligible for a SCS trial.   
 
The SCS devices used in the study are currently market approved for treatment of chronic trunk 
and/or limb pain. Objective assessments will be performed using wearable sensors that are 
commercially available.  
 
We do not foresee any additional risk, beyond those normally associated with SCS therapy. 
 
3.1 
DESCRIPTION OF SUBJECT POPULATION 
Approximately 20 patients will be enrolled in this study. The study population consists of 
patients with a diagnosis failed back surgery syndrome or chronic intractable pain who are 
eligible for a SCS trial.  Patients will be considered for enrollment by the Principal Investigator 
as a candidate for the study at the study site if they meet the inclusion/exclusion criteria 
requirements, and agree to participate in the study. 
  
3.2 
ANTICIPATED CLINICAL BENEFITS 
There are no additional clinical benefits associated with the participation in this study beyond 
those anticipated with standard clinical 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 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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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 
These adverse events and adverse device effects are not specific to the study, but related to the 
approved SCS implant procedure. 
 
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 
There are no risks associated with the participation in the study beyond those associated with to 
SCS standard of care. 
 
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 
Subjects will be informed concerning the potential risks and benefits associated with 
participation in the study prior to their enrollment. 
 
3.8 
RISK-TO-BENEFIT RATIONALE 
The study will use devices currently approved as part of standard pain management care together 
with commercially available wearable sensors.  Establishing feasibility of using wearable sensors 
to capture objective measures of patient’s activity and sleep quality during spinal cord 
stimulation (SCS) treatment continuum could provide robust outcomes not affected by 
confounding factors such as subjectivity and emotional state. 
 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
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. 
 
 STUDY DESIGN 
4.1 
PURPOSE 
The purpose of this study is to assess feasibility of using wearable sensors to capture objective 
measures of patient’s activity and sleep quality during spinal cord stimulation (SCS) treatment 
continuum using burst stimulation. 
 
4.2 
STUDY DESIGN AND SCOPE 
This is a prospective, multicenter, single arm, observational study designed to compare objective 
assessment of activity levels and sleep quality prior to trial, during trial and after permanent 
implant in failed back surgery syndrome or chronic intractable pain patients who are eligible for 
a SCS trial 
 
Patients with a diagnosis of failed back surgery syndrome or chronic intractable pain who are 
eligible for a SCS trial and recommended by the principal investigator will be approached to 
participate in the study.  The patient will be informed about the study to determine if he/she is 
interested in participating.  Subjects will be assessed at baseline using questionnaires.  
 
Specifically subjective assessments will include:  
• pain level as assessed by the VAS; 
• quality of life as assessed by the EQ-5D; 
• disability as assessed by the Oswestry Disability Index (ODI). 
 
Subjects will be provided with wearable sensors and to collect baseline objective assessments of 
activity levels and sleep quality for two weeks. Subjects will also receive a one-week pain diary 
and will be instructed to complete it in the last week before initiation of the SCS trial.  
  
Subjects will subsequently be trialed using St. Jude Medical (SJM) invisible trial system 
according to standard clinical procedures.  During the trial period subjects will continue to use 
the wearable sensors; objective assessments will be recorded during the trial while the subjective 
assessments performed at baseline will be repeated at the end of trial visit. 
Subjects obtaining at least 50% low back and lower limbs pain relief (assessed using the VAS 
questionnaire) will be eligible for permanent implant and further participation in the study. 
 
After activation of the permanent implant, subjects will be followed up for 3 months.  Objective 
assessments will be recorded using the wearable sensor throughout the 3 month duration and 
subjective assessments will be performed during the 1, 2 and 3 month follow up visits. 
 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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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 total duration of the study is expected to be 12 months. 
 
The clinical study will be conducted in three centers in the EMEA region. 
4.2.1 
Number of subjects required to be included in the study 
Approximately 20 subjects will be enrolled in the study. 
 
4.2.2 
Estimated time needed to enroll this subject population 
The study may continue up to 2 years, dependent on the rate of enrollment. 
 
4.3 
OBJECTIVES 
4.3.1 
Primary Objective 
To compare objective assessment of activity levels and sleep quality prior to trial, during trial 
and after permanent implant in failed back surgery syndrome or chronic intractable pain 
patients who are eligible for a SCS trial.  
 
4.3.2 
Secondary Objective 
To compare objective assessments obtained with wearable sensors to subjective assessments of: 
• Pain; 
• Quality of life; 
• Disability 
 
obtained using patients questionnaires. 
 
4.4 
ENDPOINTS 
4.4.1 
Primary Endpoint 
Change in activity levels and sleep quality between baseline, SCS trial and permanent implant 
follow up visits.  
 
4.4.2 
Secondary Endpoint 
• Compare changes in activity assessed using wearable sensors to changes in visual analog 
scale (VAS) pain scores, quality of life, and disability scores assessed using patient 
questionnaires 
• Compare changes in sleep quality assessed using wearable sensors to changes in visual 
analog scale (VAS) pain scores, quality of life, and disability scores assessed using patient 
questionnaires 
 
between baseline, SCS trial and 1, 2 and 3 month visits following permanent implant  
 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
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; 
• Subjects with the diagnosis of failed back surgery syndrome or chronic intractable trunk and 
lower limb pain and are eligible for a SCS trial;  
• Subjects have an average trunk pain VAS score of at least 6.0 out of 10.0, and lower limb 
pain VAS score of at least 6.0 out of 10.0 
• Subject is on  stable pain medications, as determined by the Investigator, 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; 
• Subject agrees to wear the wearable sensor for the duration of the study 
• 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 
 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 17 of 44 
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disclosed or used without the express written consent of St. Jude Medical 
• 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 diagnosed with neurological deficits affecting the lower limbs; 
• Subject diagnosed with fibromyalgia or chronic fatigue; 
• 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; 
• Subjects with concurrent clinically significant or disabling chronic pain problem that requires 
additional treatment;  
• 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-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 18 of 44 
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4.6 
SUBJECT POPULATION 
The study population consists of patients with a diagnosis of failed back surgery syndrome or chronic 
intractable pain patients who are eligible for a SCS trial.  Patients will be considered for enrollment by 
the Principal Investigator as a candidate for the study at the study site if they meet the 
inclusion/exclusion criteria requirements, and agree to participate in the study. 
 
4.6.1 
Subject Screening 
Patients who are recommended by the Investigator as a candidate for the study will be fully informed 
about the study and asked to participate in the study.  In case the patient agrees, a duly signed and dated 
Patient Informed Consent will be obtained.  Subjects will 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. 
 
4.6.2 
Point of Enrollment 
Subjects are considered enrolled in the study from the moment the subject has provided written Patient 
Informed Consent. (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-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 19 of 44 
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or used without the express written consent of St. Jude Medical 
 DEVICE UNDER INVESTIGATION AND CONTROL/COMPARATORS (IF APPLICABLE) 
5.1 
DEVICE DESCRIPTION 
In this study, the SJM Invisible trial system and the Proclaim, Prodigy or the Prodigy MRI  
neurostimulation system will be used. The SCS system consists of the following devices 
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 Percutaneous trial lead 
31XX 
Released 
SJM Lead extension 
33XX 
Released 
SJM Prodigy internal pulse generator 
(IPG) 
3799 
Released 
SJM Prodigy MRI IPG 
3772 
Released 
SJM Prodigy Charger 
3730 
Released 
SJM Prodigy Patient Programmer 
3856 
Released 
SJM Rapid Programmer programming 
device 
3835 
Released 
SJM Proclaim IPG 
3660, 3662 
Released 
SJM Clinician Programmer App 
3874 
Released 
SJM Patient Controller App 
3875 
Released 
SJM Octrode™ lead 
318X 
Released 
SJM Cinch™ Lead Anchor 
1194 
Released 
SJM Swift-Lock™ Anchor 
1192 
Released 
Actigraph wearable sensor 
GT9X link activity monitor 
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 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 20 of 44 
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• 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 
• SJM Lead extension: sterile extension that connects the pulse generator to the stimulating electrode 
• SJM Prodigy: 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: 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 Charger: The IPG Charging System provides the capability to recharge the IPG 
battery while stimulation is either on or off.  The charging system has several main parts: AC line 
cord, AC power supply, power cable, and charger antenna.  The charger transmits RF energy 
through the antenna to the IPG battery to recharge it. 
• SJM Patient Programmer: the patient programmer allows subjects to adjust stimulation intensity 
and to select a different stimulation programs in the Prodigy MRI IPG. 
• SJM Rapid Programmer: the rapid programmer enables the clinician to program the Prodigy IPG.   
• 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 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 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 
• Actigraph GT9X link activity monitor: wrist worn watch containing a gyroscope, magnetometers 
and 3-axis accelerometer designed for objective assessment of activity and sleep quality 
 
5.2 
DEVICE ACCOUNTABILITY (if applicable) 
Device accountability is not required in post market studies. 
  

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 21 of 44 
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or used without the express written consent of St. Jude Medical 
 PROCEDURES 
6.1 
STUDY FLOW CHART 
 
Figure 2: Study Flow Chart 
 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 22 of 44 
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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 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 
SCS Trial 
End of 
Trial 
SCS 
Implant 
Procedure 
Activation 
Follow up 
Visits* 
Informed Consent Process 
X 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
Screening 
X 
 
 
 
 
 
 
VAS assessment 
 
X 
 
X 
 
 
X 
EQ-5D questionnaire 
 
X 
 
X 
 
 
X 
ODI questionnaire 
 
X 
 
X 
 
 
X 
Provide wearable sensor 
 
X 
 
 
 
 
 
Provide pain diary 
 
X 
X 
 
 
X 
X 
Collect wearable sensor data 
 
 
X 
X 
 
 
X 
Collect pain diary 
 
 
X 
X 
 
 
X 
Trial system implant 
 
 
X 
 
 
 
 
Permanent lead implant 
 
 
 
 
X 
 
 
IPG implant 
 
 
 
 
X 
 
 
IPG Programming 
 
 
 
 
 
X 
 
*Follow up visit assessments will be performed after activation visit at weeks 4 (28±7 days), 8 (56±7 
days) and 12 (84±7 days). 
 
6.3 
ENROLLMENT  
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 
 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  
 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 23 of 44 
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NOTE: As soon as the subject signs the Patient Informed Consent, adverse events need to be reported 
according to the guidelines mentioned in section 8.2. 
 
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 screening: 
 
Timing of visit 
Activities at visit 
Case Report Form 
Screening 
• Subject is screened for inclusion/exclusion 
criteria 
• Subject signs informed consent 
• Enrollment Form 
• Inclusion/Exclusion Form 
 
 
6.4 
BASELINE VISIT 
Baseline visit activities can occur at the same visit of enrollment after the informed consent has been 
obtained.   
Subjects will complete the questionnaires to assess:  
• pain level as assessed by the VAS; 
• quality of life as assessed by the EQ-5D; 
• disability as assessed by the ODI   
Subjects will be provided with the wearable sensor and will be instructed on the correct usage.  Subjects 
will also be provided with a one-week pain diary and instructed to complete it on the last week before 
initiation of the SCS trial. 
 
 
 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 24 of 44 
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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 
Screening 
• Subject assess pre-trial pain levels, quality of 
life and, disability,Provide wearable sensor 
• Provide one-week pain diary 
• VAS Form 
• EQ-5D Form 
• ODI From 
 
 
6.5 
SCS Trial 
Subjects will report for SCS trial system implant.  Pain diaries will be collected.  Subjects will be 
provided with a new one-week pain diary and instructed to complete it in the last week before the “end 
of trial” visit.  Data stored in the wearable sensors will be downloaded and stored securely in a computer 
such that can be traced to the subject ID and study visit.  Wearable sensor memory will be wiped clean 
and devices prepared for the next acquisition period. 
 
Subject will be implanted according to standard of care with a SJM invisible trial system.   
EPG will be programmed using burst stimulation according to standard programming techniques. 
 
The following activities and assessments will be performed during SCS trial: 
 
Timing of visit 
Activities at visit 
Case Report Form 
SCS Trial 
• SCS trial lead implant 
• EPG programming 
• Collect pain diary 
• Collect wearable sensor baseline data 
• Provide pain diary 
• VAS Pain Diary Form 
 
6.6 
END OF TRIAL VISIT 
During the End of Trial visit, subjects will complete the same questionnaires completed during the 
baseline visit.  Pain diaries will be collected.  Data stored in the wearable sensors will be downloaded 
and stored securely in a computer such that can be traced to the subject ID and study visit.  Wearable 
sensor memory will be wiped clean and devices prepared for the next acquisition period.  Subjects will 
be instructed not to wear the wearable sensor until the activation visit. 
 
If the VAS score is >50% of the VAS collected during the screening visit the subject will exit the study. 
Subjects whose VAS score at the end of the trial is ≤50% of the VAS collected during the screening visit 
will be considered for permanent lead and IPG implantation. 
 
The following activities and assessments will be performed during end of trial visit: 
 
Timing of visit 
Activities at visit 
Case Report Form 
End of Trial 
• Subject assess during-trial pain levels, quality 
of life and disability 
• Collect pain diary 
• VAS Form 
• EQ-5D Form 
• ODI From 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 25 of 44 
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• Collect wearable sensor SCS trial data 
• VAS Pain Diary Form 
 
6.7 
PERMANENT IMPLANT 
Permanent implant will be performed according to standard clinical practice 
 
The following activities and assessments will be performed during SCS implant: 
 
Timing of visit 
Activities at visit 
Case Report Form 
SCS Implant 
• SCS permanent lead implant 
• IPG implant 
 
 
6.8 
ACTIVATION VISIT 
IPG will be programmed using burst stimulation according to standard programming techniques. 
Subjects will be provided with a new one-week pain diary and instructed to complete it in the last week 
before the first “follow up” visit. Subjects will be instructed to start wearing the wearable sensor again.   
 
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 
 
 
6.9 
SCHEDULED FOLLOW-UPS 
Subjects will be followed up for 3 months at one-month intervals. During each visit, subjects will 
complete the same questionnaires completed during the baseline visit.  Pain diaries will be collected.  
Subjects will be provided with a new one-week pain diary and instructed to complete it in the last week 
before the next “follow up” visit. Data stored in the wearable sensors will be downloaded and stored 
securely in a computer such that can be traced to the subject ID and study visit.  Wearable sensor 
memory will be wiped clean and devices prepared for the next acquisition period.   
 
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 during-trial pain levels, quality 
of life and disability 
• Collect pain diary 
• Collect wearable sensor SCS trial data 
• VAS Form 
• EQ-5D Form 
• ODI From 
• VAS Pain Diary Form 
 
6.10 
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. 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 26 of 44 
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The visit should be documented by completing the Unscheduled Visit Form and any other applicable 
forms (Adverse Event, Deviation, Death and/or Withdrawal Form. 
 
 
6.11 
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 
 
6.12 
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. 
 
6.13 
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.  
 
6.14 
CRITERIA AND PROCEDURES FOR SUBJECT WITHDRAWAL OR DISCONTINUATION 
Each subject should remain in the study until completion of the required follow up period; however, a 
subject’s participation in the study may be discontinued at any time.  Should this occur, the reason for 
discontinuation must be documented in the withdrawal form. 
 
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. 
 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 27 of 44 
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 
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 
 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 third follow up visit will be the final study visit. The subject will complete the questionnaires as in 
the previous follow up visit, return the last pain diary, return the wearable sensor and will exit the study. 
  
 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. 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 28 of 44 
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 
 
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 
 
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 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 29 of 44 
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or used without the express written consent of St. Jude Medical 
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). 
 
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. 
 
 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, 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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or used without the express written consent of St. Jude Medical 
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. 
 
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. 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 31 of 44 
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 
 
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. 
 
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 or 
through the EDC system. 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.  
 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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or used without the express written consent of St. Jude Medical 
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) 
 (if applicable) device deficiencies, that could have led to a serious adverse device effect 
o if either suitable action had not been taken;  
o if intervention had not been made or 
o if circumstances had been less fortunate 
 
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.  
 
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. 
 
 
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. 
All subjects’ deaths should be documented using the “Death Form” and a “Withdrawal Form”. 
 
8.4 
DEVICE DEFICIENCY (DD)  
• 
A Device Deficiency is defined as an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance. 
• 
 
• 
Device deficiencies include malfunctions, use errors and inadequate labeling. 
• 
 
St. Jude Medical will appropriately manage all device deficiencies related to the identity, quality, 
durability, reliability, safety or performance of an investigational medical device.  All device 
deficiencies will be documented throughout the clinical study. 
 
NOTE:  Device deficiencies that occur in investigational products must be captured on case report forms 
that include user error information. 
 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 33 of 44 
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 
Device deficiencies in St. Jude Medical market-released products must be reported per St. Jude Medical 
product surveillance process. 
 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. 
 
During this study the following documents will be produced: 
• Patient’s ICF 
• Enrollment clinical report form 
• Inclusion/Exclusion clinical report form 
• VAS clinical report form 
• EQ-5D clinical report form 
• ODI clinical report form 
The ICF, VAS, EQ-5D and ODI clinical report forms will be translated in the language of the country or 
countries where the study will be conducted. 
  
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 
Data are captured on paper CRFs which are verified and signed by the Principal Investigator or his/her 
designee.  Paper CRFs will be electronically sent to SJM and then captured in a validated electronic 
database management system hosted by 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. 
 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 34 of 44 
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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. 
 MONITORING  
Centralized monitoring will occur through routine internal data review.  This monitoring is designed to 
identify missing and inconsistent data, data outliers, and potential protocol deviations that may be 
indicative of site non-compliance. On site monitoring may occur at the discretion of the sponsor.  
 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. 
• 
 
• 
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. 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 35 of 44 
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 
 
STATISTICAL CONSIDERATIONS 
12.1 
STATISTICAL DESIGN, HYPOTHESES, METHOD AND ANALYTICAL PROCEDURES 
This study is a prospective, single arm, open label observational study.  The analysis will be conducted 
under the null hypothesis that SCS treatment will increase the activity level and sleep quality in the 
subjects.  Data collected from wearable sensors will be compared between the baseline, trial and follow 
up periods using a repeated measurement ANOVA analysis followed by post-hoc testing. 
 
12.2 
SAMPLE SIZE 
We will enroll approximately 20 subjects in three study centers in the EU. 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. 
 
 
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. 
 
The sponsor will archive and retain all essential clinical study documents from prior, during and (as 
specified) after the clinical study as per requirements.  
 
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. 
 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 36 of 44 
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 
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. 
 
 
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)  
 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. 
 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 37 of 44 
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 
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.   
 
 
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 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
Template: 86357  Rev. A                                                                                                                       Page 38 of 44 
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 
 
 
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. 
 
 
BIBLIOGRAPHY  
 
Bonica JJ. The need of a taxonomy. Pain. 1979;6(3):247–8 
 
Dansie EJ, Turk DC, Martin KR, Van Domelen DR, Patel KV. Association of chronic widespread pain 
with objectively measured physical activity in adults: findings from the National Health and Nutrition 
Examination survey. J Pain. 2014 May;15(5):507-15 
 
Emery PC, Wilson KG, Kowal J. Major depressive disorder and sleep disturbance in patients with 
chronic pain. Pain Res Manag. 2014 Jan-Feb;19(1):35-41. 
 
Gong W, Johanek LM, Sluka KA. Spinal cord stimulation reduces mechanical hyperalgesia and restores 
physical activity levels in animals with noninflammatory muscle pain in a frequency-dependent manner. 
Anesth Analg. 2014 Jul;119(1):186-95. 
 
McGrath PA. Psychological aspects of pain perception. Arch Oral Biol. 1994;39 Suppl:55S-62S. 
 
Nascimento-Ferreira MV, Collese TS, de Moraes AC, Rendo-Urteaga T, Moreno LA, Carvalho HB. 
Validity and reliability of sleep time questionnaires in children and adolescents: A systematic review 
and meta-analysis. Sleep Med Rev. 2015 Dec 6;30:85-96 
 
Obuchi M, Sumitani M, Shin M, Ishii K, Kogure T, Miyauchi S, Yamada Y. Spinal cord stimulation 
ameliorates neuropathic pain-related sleep disorders: a case series. Neuromodulation. 2015 pr;18(3):191-
3; 
 
Ramineni T, Prusik J, Patel S, Lange S, Haller J, Fama C, Argoff C, Pilitsis J. The Impact of Spinal 
Cord Stimulation on Sleep Patterns. Neuromodulation. 2016 Feb 5. 
 
Sato KL, Johanek LM, Sanada LS, Sluka KA. Spinal cord stimulation (SCS) improves decreased 
physical activity induced by nerve injury. Behav Neurosci. 2014 Oct;128(5):625-32. 
 
Wilson AC, Palermo TM. Physical activity and function in adolescents with chronic pain: a controlled 
study using actigraphy. J Pain. 2012 Feb;13(2):121-30. 
 
 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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or used without the express written consent of St. Jude Medical 
APPENDIX A: ABBREVIATIONS 
Abbreviation 
Term 
ADE 
AE 
ASADE 
CA 
CIP 
CRF 
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  
SJM 
USADE 
VAS 
WMA 
Adverse Device Effect 
Adverse Event 
Anticipated Serious Adverse Device Effect 
Competent Authority 
Clinical Investigational Plan 
Case Report Form 
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 
St. Jude Medical 
Unanticipated Serious Adverse Device Effect 
Visual Analog Scale 
World Medical Association 
 
 
 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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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-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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Appendix C: DECLARATION OF HELSINKI 
The most current version of the document will be followed. 
 
 

Study Document No: SJM-CIP-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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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-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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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-10133 Ver. A 
Study Name: OASIS 
Clinical Investigational Plan 
 
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Appendix F: CASE REPORT FORMS 
Case report forms will be kept under a separate cover and are available upon request.