Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System
Conditions: Parkinson Disease
Sponsor: Abbott Medical Devices

 
Clinical Investigation Plan Cover Page 
 
 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott. 
87173 CIP Posting Cover Page Ver C 
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NCT Number: 02989610 
PROGRESS 
Post-Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse 
Generator System 
Study Document No: ABT-CIP-10477 
Version A 
Date: 25-NOV-2019 
 
 
Sponsor  
 
 
Abbott 
         
 
 
Avenue Da Vincilaan 11 
      
  
 
 
B-1935 Zaventem 
         
 
 
Belgium 
 

 
Study Document No: SJM-CIP-10061 Ver. G 
Study Name: PROGRESS 
Clinical Investigational Plan 
 
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or used without the express written consent of St. Jude Medical 
 
 
Reference:  
SJM-CIP-10061 
 
 
“PROGRESS” 
 
 
 
Clinical Investigation Plan (CIP) 
 
Sponsor  
 
 
 
 
SJM International, Inc.  
The Corporate Village  
Da Vincilaan 11- box F1  
1935 Zaventem  
Belgium  
Tel: +32 2 774 67 45  
Fax: +32 2 772 83 84 
 
St. Jude Medical 
6901 Preston Road 
Plano, TX 75024 
Tel:  +1 972 309 8000 
 
 
 

 
Study Document No: SJM-CIP-10061 Ver. G 
Study Name: PROGRESS 
Clinical Investigational Plan 
 
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PRINCIPAL INVESTIGATOR SIGNATURE PAGE 
PROGRESS 
 
Version G 
Reference #: SJM-CIP-10061 
 
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-10061 Ver. G 
Study Name: PROGRESS 
Clinical Investigational Plan 
 
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Coordinating Investigator/National Investigator/Medical Advisor 
 
SIGNATURE PAGE 
 
 
PROGRESS 
 
Version G 
Reference #: SJM-CIP-10061 
 
 
I have read and agree to adhere to the clinical investigational plan and all regulatory requirements 
applicable in conducting this clinical study.   
 
 
Coordinating Investigator:   
 
Printed name: 
____________________________________ 
 
Signature: _______________________________________ 
 
Date:  ____________________ 
 
 
 
Co-Coordinating Investigator:   
 
 
Printed name: 
____________________________________ 
 
Signature: _______________________________________ 
 
Date:  ____________________ 
 

 
Study Document No: SJM-CIP-10061 Ver. G 
Study Name: PROGRESS 
Clinical Investigational Plan 
 
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Table of Contents 
Page 
 
SYNOPSIS ................................................................................................................................. 6 
1.1 
STUDY FLOW CHART ............................................................................................................................... 8 
1.2 
STUDY CONTACTS ................................................................................................................................... 9 
 
BACKGROUND AND JUSTIFICATION FOR CLINICAL STUDY.............................................. 10 
 
RISKS AND BENEFITS OF THE CLINICAL STUDY ................................................................ 13 
3.1 
DESCRIPTION OF SUBJECT POPULATION ......................................................................................... 13 
3.2 
ANTICIPATED CLINICAL BENEFITS ...................................................................................................... 13 
3.3 
ANTICIPATED ADVERSE EVENTS AND ADVERSE DEVICE EFFECTS ............................................. 13 
3.4 
RESIDUAL RISKS ASSOCIATED WITH THE DEVICE UNDER INVESTIGATION, AS IDENTIFIED IN 
THE RISK ANALYSIS REPORT ......................................................................................................................... 15 
3.5 
RISKS ASSOCIATED WITH PARTICIPATION IN THE CLINICAL STUDY ............................................ 15 
3.6 
POSSIBLE 
INTERACTIONS 
WITH 
CONCOMITANT 
MEDICAL 
TREATMENTS 
AND/OR 
CONCURRENT MEDICAL INTERVENTIONS ................................................................................................... 15 
3.7 
STEPS THAT WILL BE TAKEN TO CONTROL OR MITIGATE THE RISKS .......................................... 16 
3.8 
RISK-TO-BENEFIT RATIONALE ............................................................................................................. 16 
3.9 
DESCRIPTION OF HISTORY OF MODIFICATIONS OR RECALL IN RELATION TO SAFETY AND 
CLINICAL PERFORMANCE FOR DEVICE UNDER INVESTIGATION ............................................................. 16 
 
STUDY DESIGN ...................................................................................................................... 16 
4.1 
PURPOSE ................................................................................................................................................ 16 
4.2 
STUDY DESIGN AND SCOPE ................................................................................................................ 16 
4.3 
OBJECTIVES ........................................................................................................................................... 18 
4.4 
ENDPOINTS ............................................................................................................................................. 18 
4.5 
INCLUSION AND EXCLUSION CRITERIA .............................................................................................. 19 
4.6 
SUBJECT POPULATION ......................................................................................................................... 19 
4.7 
INFORMED CONSENT PROCESS ......................................................................................................... 20 
 
DEVICE UNDER INVESTIGATION AND CONTROL/COMPARATORS (IF APPLICABLE) ...... 21 
5.1 
DEVICE DESCRIPTION ........................................................................................................................... 21 
5.2 
DEVICE HANDLING AND STORAGE ..................................................................................................... 22 
 
PROCEDURES ........................................................................................................................ 23 
6.1 
STUDY FLOW CHART ............................................................................................................................. 23 
6.2 
STUDY VISITS ......................................................................................................................................... 24 
6.3 
ENROLLMENT VISIT ............................................................................................................................... 26 
6.4 
BASELINE VISIT ...................................................................................................................................... 27 
6.5 
IMPLANT/PROCEDURE .......................................................................................................................... 27 
6.6 
SCHEDULED FOLLOW-UPS ................................................................................................................... 28 
6.7 
UNSCHEDULED VISITS .......................................................................................................................... 32 
6.8 
DESCRIPTION OF ACTIVITIES PERFORMED BY SPONSOR REPRESENTATIVES ......................... 32 
6.9 
SUBJECT STUDY COMPLETION ........................................................................................................... 32 
6.10 ANY KNOWN OR FORSEEABLE FACTORS THAT MAY COMPROMISE THE OUTCOME OF THE 
CLINICAL STUDY OR THE INTERPRETATION OF THE RESULTS ................................................................ 33 
6.11 DESCRIPTION OF THE METHODS THAT WILL BE USED TO ADDRESS POTENTIALLY 
CONFOUNDING FACTORS IN THE CLINICAL STUDY DESIGN (E.G. STRATIFIED RANDOMIZATION, 
STATISTICAL ANALYSIS, ETC.) ........................................................................................................................ 33 
6.12 CRITERIA AND PROCEDURES FOR SUBJECT WITHDRAWAL OR DISCONTINUATION ................. 33 
 
COMPLIANCE TO CIP ............................................................................................................. 34 
7.1 
STATEMENTS OF COMPLIANCE ........................................................................................................... 34 
7.2 
ADHERENCE TO THE CLINICAL INVESTIGATION PLAN .................................................................... 34 

 
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Clinical Investigational Plan 
 
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7.3 
REPEATED AND SERIOUS NON-COMPLIANCE .................................................................................. 35 
 
ADVERSE EVENT, ADVERSE DEVICE EFFECT, DEVICE DEFICIENCY .............................. 36 
8.1 
DEFINITIONS ........................................................................................................................................... 36 
8.2 
PROCEDURE FOR ASSESSING, RECORDING, AND REPORTING ADVERSE EVENTS, DEVICE 
DEFICIENCIES/COMPLAINTS, ADVERSE DEVICE EFFECTS, SERIOUS ADVERSE EVENTS, AND 
SERIOUS ADVERSE DEVICE EFFECTS: ......................................................................................................... 37 
8.3 
SUBJECT DEATH .................................................................................................................................... 38 
8.4 
DEVICE DEFICIENCY (DD)/COMPLAINT REPORTING ........................................................................ 38 
 
DATA MANAGEMENT ............................................................................................................. 39 
9.1 
DATA MANAGEMENT PLAN ................................................................................................................... 39 
9.2 
DOCUMENT AND DATA CONTROL ....................................................................................................... 39 
 
MONITORING .......................................................................................................................... 40 
 
REGULATORY INSPECTIONS................................................................................................ 40 
 
STATISTICAL CONSIDERATIONS .......................................................................................... 41 
12.1 STATISTICAL DESIGN, HYPOTHESES, METHOD AND ANALYTICAL PROCEDURES ..................... 41 
12.2 SAMPLE SIZE .......................................................................................................................................... 43 
12.3 PASS/FAIL CRITERIA TO BE APPLIED TO THE RESULTS OF THE CLINICAL STUDY ..................... 43 
12.4 THE PROVISION FOR AN INTERIM ANALYSIS, WHEN APPLICABLE ................................................ 43 
12.5 CRITERIA FOR THE TERMINATION OF THE CLINICAL STUDY ON STATISTICAL GROUNDS ....... 43 
12.6 PROCEDURES FOR REPORTING ANY DEVIATION(S) FROM THE ORIGINAL STATISTICAL PLAN
 
43 
12.7 THE SPECIFICATION OF SUBGROUPS FOR ANALYSIS .................................................................... 43 
12.8 PROCEDURES THAT TAKE INTO ACCOUNT ALL THE DATA............................................................. 43 
12.9 THE TREATMENT OF MISSING, UNUSED, OR SPURIOUS DATA, INCLUDING DROP-OUTS AND 
WITHDRAWALS .................................................................................................................................................. 44 
12.10 THE EXCLUSION OF PARTICULAR INFORMATION FOR THE TESTING OF THE HYPOTHESIS .... 44 
12.11 IN MULTI-CENTER STUDIES, THE MINIMUM AND MAXIMUM NUMBER OF SUBJECTS TO BE 
INCLUDED FOR EACH CENTER ....................................................................................................................... 44 
12.12 TIMING FOR ANALYSES......................................................................................................................... 44 
 
DOCUMENT RETENTION ....................................................................................................... 44 
 
AMENDMENTS TO CLINICAL INVESTIGATIONAL PLAN ...................................................... 44 
 
INVESTIGATION SUSPENSION OR TERMINATION .............................................................. 45 
15.1 PREMATURE TERMINATION OF THE WHOLE CLINICAL STUDY OR OF THE CLINICAL STUDY IN 
ONE OR MORE INVESTIGATIONAL SITES ...................................................................................................... 45 
15.2 RESUMING THE STUDY AFTER TEMPORARY SUSPENSION ........................................................... 46 
15.3 STUDY CONCLUSION ............................................................................................................................. 47 
 
PUBLICATION POLICY ........................................................................................................... 47 
 
BIBLIOGRAPHY ...................................................................................................................... 47 
APPENDIX A: ABBREVIATIONS ......................................................................................................... 49 
APPENDIX B: CIP REVISION HISTORY ............................................................................................. 50 
APPENDIX C: DECLARATION OF HELSINKI ..................................................................................... 52 
APPENDIX D: INFINITY DBS SYSTEM COMPONENTS .................................................................... 53 
APPENDIX E: LIST OF CLINICAL INVESTIGATION SITES AND IRB/EC .......................................... 54 
APPENDIX F: SAMPLE INFORMED CONSENT ................................................................................. 54 
APPENDIX G: CASE REPORT FORMS .............................................................................................. 54 

 
Study Document No: SJM-CIP-10061 Ver. G 
Study Name: PROGRESS 
Clinical Investigational Plan 
 
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 SYNOPSIS  
Title 
Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation 
Implantable Pulse Generator System 
Acronym 
PROGRESS 
Purpose 
The purpose of this post market study is to characterize the clinical performance of 
the Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG), DBS 
leads, extensions and related system components. 
Primary 
Objective 
Demonstrate superiority of the directional lead DBS therapeutic window to the 
omnidirectional lead DBS therapeutic window.  
Secondary 
Objectives   
Demonstrate non-inferiority of the directional lead DBS therapeutic window to the 
omnidirectional lead DBS therapeutic window and compare Unified Parkinson’s 
disease Rating Scale (UPDRS part III motor examination) at 3 and 6 months to 
evaluate therapeutic differences in omnidirectional vs directional stimulation. 
Primary 
Endpoint 
 
The proportion of subjects for which at least one lead’s therapeutic window 
(evaluated by a blinded evaluator) is greater using directional stimulation than 
omnidirectional stimulation, tested against a performance goal of 60% at the 3-
month follow-up visit. 
Secondary 
Endpoints 
 
If primary endpoint not met, the proportion of subjects with a therapeutic window 
(evaluated by a blinded evaluator) which is larger under directional stimulation than 
omnidirectional stimulation tested against a performance goal of 40% at the 3 
month follow-up visit; Comparison of 3-month vs. 6-month UPDRS part III motor 
examination scores (evaluated by a blinded evaluator) to assess therapeutic 
differences in omnidirectional vs. directional stimulation.  
Descriptive 
Endpoints 
Evaluation of subject and clinician stimulation preference at 6-month follow-up visit; 
Change in therapeutic effectiveness measured by UPDRS part III motor 
examination at the 12-month follow-up visit from baseline visit; 
Change in Activities of Daily Living (ADLs) measurement as determined from the 
UPDRS part II ADLs at the 3-, 6-, and 12-month follow-up visits from baseline visit; 
Change in quality-of-life measurement as measured by the Parkinson’s Disease 
Questionnaire (PDQ-39) at the 3-, 6-, and 12-month follow-up visits from baseline 
visit; 
Evaluation of device-related adverse events; 
Evaluation of subject and programmer satisfaction with product usability at the 12-
month follow-up visit; 
Comparison of mean values of therapeutic window with directional and 
omnidirectional stimulation; 
Current (amplitude) at which first sustainable side effect is observed with 
directional and omnidirectional stimulation; 
Current (amplitude) at which first sustainable stimulation-induced side effect is 
observed with directional and omnidirectional stimulation; 
Minimum therapeutic current with directional and omnidirectional stimulation; 
Optimal therapeutic current with directional and omnidirectional stimulation; 

 
Study Document No: SJM-CIP-10061 Ver. G 
Study Name: PROGRESS 
Clinical Investigational Plan 
 
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Total amount of time required for each study visit and programming. 
Long-term outcomes evaluated by change compared to baseline in UPDRS part III 
motor examination, UPDRS part II ADLs and PDQ-39, at the 36-month follow-up 
visit. 
Design 
This study is designed as a prospective, blinded-subject, blinded-evaluator, 
observational, multi-center 36 month post market clinical follow up study.  The total 
duration of this study is expected to be 60 months. The clinical study will be 
conducted at up to 60 centers in the European Union, United States, Latin 
America, and Australia.  Up to 350 subjects will be enrolled. The primary endpoint 
analysis will be performed when 66 subjects have completed 12 months of follow-
up and have evaluable primary endpoint at the 3-month follow-up visit. Interim 
annual progress reports will be reported to comply with Post-Market Clinical 
Follow-up (PMCF) requirements. 
 
Baseline data can be collected from the subject’s medical records to compare to 
follow-up visits.  Data will be collected 3, 6, 12, 24 and 36 months after initial 
programming for comparison to baseline. 
 
A subset of subjects enrolled in this study will be used to meet the PMCF 
requirement for CE mark. Once this subset of subjects is enrolled and followed for 
12 months and have evaluable primary endpoint at the 3-month follow-up visit, a 
report will be submitted indicating completion of this requirement. 
Devices 
Used 
The following devices will be used in the study: 
Infinity DBS System  
Infinity DBS system including Implantable Pulse Generator (IPG), the 4 and 8 
channel leads and accessories 
Infinity Clinician Programmer App and Patient Controller App 
Study 
Population 
Subjects who have a diagnosis matching the approved indication and are 
being considered for a DBS implant or who have been implanted with an 
Infinity system comprise the target population for this study. Subjects 
who meet all of the inclusion criteria and none of the exclusion criteria, and who 
have signed a statement of informed consent approved by an Ethics Committee 
(EC) or Institutional Review Board (IRB), will be enrolled in the study. 
 
The PMCF requirement will be complete when 66 subjects have been followed for 
12 months and have evaluable primary endpoint at the 3-month follow-up visit. 
Inclusion/ 
Exclusion 
Criteria  
Inclusion Criteria 
Subject is able to provide informed consent; 
Subject is diagnosed with Parkinson’s disease (PD) and has been recommended 
to receive a bilateral DBS implant in the Subthalamic Nucleus (STN), or has been 
implanted bilaterally with an Infinity system in the STN; 
Subject must be available for follow-up visits. 
Exclusion Criteria 
Subject is not a surgical candidate; 
In the investigator’s opinion, the subject is unable to tolerate multiple programming 
sessions within a single setting; 

 
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Subject is unable to comply with the follow-up schedule. 
 
Data 
Collection 
Data will be collected at baseline, initial programming, and 3 months, 6 months, 12 
months, 24 months and 36 months after initial programming date. 
 
Retrospective chart review or prospective completion of the baseline study 
evaluations may be conducted for each subject. Retrospective collection of the 
most recently documented UPDRS part II ADLs and UPDRS part III motor scores 
(on and off medication) can be used as baseline data for comparison to 3-, 6-, 12- 
and 36-month data. 
 
Subjects will undergo DBS system implantation in accordance with the physicians’ 
standard operating procedures. Subjects will return for the initial programming visit 
according to the site’s normal standard of care. The initial programming date will be 
classified as “Day 0”. At the initial programming visit, the leads will be tested 
according to the site’s standard monopolar review followed by omnidirectional 
testing.  After Day 0, subjects will return to the clinic for evaluations at 3 months 
(±30 days), 6 months (±30 days), 12 months (±60 days), 24 months (±90 days) and 
36 months (±90days). At the 3- and 6-month visits, Parkinson’s disease symptoms 
will be evaluated by a blinded evaluator using the UPDRS part III motor 
examination. At the 3-, 6- 12- and 36-month visits, subjects will be evaluated using 
the UPDRS part II for the ability to perform activities of daily living in the Stimulation 
On state, and will complete the PDQ-39 to evaluate quality-of-life. At the 3-, 12- 
and 36-month visits, a detailed omnidirectional and directional programming 
assessment will be performed. The right and left lead will be tested independently 
in multiple programming configurations. Amplitude will be increased slowly by the 
programmer until first meaningful therapeutic effect is confirmed by the blinded 
evaluator. Amplitude will continue to be increased slowly by the programmer until 
the first sustainable side effect is observed by the blinded evaluator. 
 
The subject and programmer will also complete the System Usability Scale (SUS) 
at the 12-month visit to assess the ease of use of the device.   
 
The PMCF requirement will be met when 66 subjects have been followed for 12 
months and have evaluable primary endpoint at the 3-month follow-up visit. 
 
 
1.1 
STUDY FLOW CHART 
 
 
 
*Subjects may be enrolled in the study after device implant. 
 
 
 
Subject 
Implanted* 
Subject 
Enrolled 
Eligibility 
Assessed 
3 Month 
Follow-up 
12 Month 
Follow-up 
Study Completion 
Initial 
Programming 
 6 Month 
Follow-up 
24 Month 
Follow-up 
36 Month 
Follow-up 

 
Study Document No: SJM-CIP-10061 Ver. G 
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Clinical Investigational Plan 
 
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1.2 
STUDY CONTACTS 
Binith Cheeran, M.D. 
Medical Director 
XXXXXXXXXXXXXXXXXX 
 
Edward Karst 
Director of Clinical Research 
XXXXXXXXXXXXXXXXXXXX 
 
Florence Defresne 
Principal Scientist 
XXXXXXXXXXXXXXXXXXXX 
 
 

 
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 BACKGROUND AND JUSTIFICATION FOR CLINICAL STUDY 
Deep Brain Stimulation (DBS) has become an indispensable therapeutic tool for treating Parkinson’s 
disease, dystonia and tremor, which provides an opportunity for significant symptom relief and quality of 
life improvement with minimal risk [1]. It is preferred over surgical treatment due to its adjustability, 
reversibility, long lasting and robust clinical effectiveness and safety. 
 
DBS is intended to modulate dysfunctional circuits in the brain so that the brain can function more 
effectively. This is accomplished by sending continuous electrical signals to specific target areas of the 
brain, which block the impulses that cause neurological dysfunctions. Targets include the globus 
pallidus internus (GPi) and the subthalamic nucleus (STN). Patients with DBS experience considerable 
improvements in their motor symptoms and are sometimes able reduce medication usage [2-4]. 
 
Despite the proven efficacy of DBS, the benefit of this therapy is highly dependent on the distribution of 
the stimulation field within the brain anatomy. Due to the omnidirectional nature of lead design 
combined with the complex functional anatomy of DBS brain targets, today’s DBS leads offer limited 
control over the area of stimulation delivery. As a result, the propagation of current beyond the specific 
brain target stimulation-induced side effects are very common with 4 electrode lead designs. Common 
side effects include cognitive impairment, memory deficits, difficulties with speech, disequilibrium, 
dysphagia, and motor and sensory disturbances [5]. The effects are most frequently related to 
suboptimal lead placement and an inability to finely control the volume of tissue activated (VTA). 
Additionally, the non-spherically shaped targets of DBS indicate a need for programming that allows for 
the ability to shape the electrical field and potentially reduce the spread of current to unintended areas 
of the brain. 
 
In addition to the surgical procedure, a critical aspect of successful DBS is programming of the system 
such that optimal stimulation for alleviation of clinical symptoms is accomplished without the 
introduction of unwanted side effects. 
 
The advantages of DBS is that it allows for both unilateral and/or bilateral coverage of symptoms, it is 
reversible as well as can be tailored to a patient’s clinical status (parameters are adjustable allowing for 
minimization of stimulation induced side effects and improvements in efficacy over time), and the 
system can provide continuous symptom control 24 hours a day with minimum patient and physician 
involvement. The electrodes and electrical systems that provide stimulation are generally very well 
tolerated with no significant changes in surrounding brain tissue [6]. 
 
However, DBS requires millimeter accuracy in targeting of specific deep brain nuclei and when 
misplaced may cause electrical current to spread to the surrounding associative, motor and limbic 
areas running through the target nuclei which can lead to serious adverse effects. Recently, literature 
indicates that controlling the directionality of the current in DBS more precisely could lead to improved 
effectiveness and/or reduced side effects [7, 8, 9, 10]. Like DBS, Spinal Cord Stimulation (SCS) utilizes 
leads to deliver electric impulses to target areas to alleviate clinical symptoms. However, technological 
advancements in SCS leads that allow for the ability to steer current into the dorsal horns and away 
from the dorsal roots have led to improved long-term outcomes and an expanded indication for SCS for 
chronic back pain. This is accomplished through the multitude of electrode configurations, sizes, 
quantity and shapes which afford physicians an ability to customize lead selection to each patient and 
control the stimulation delivered to the intended target. Such advancements are being evaluated but 
have not yet been made commercially available for DBS. 
 

 
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Consequently, both computational modeling studies and clinical studies have shown that segmentation 
of the electrodes allows for expanded programming options, which could potentially reduce side effects, 
widen the therapeutic range, and lower the therapeutic current [8, 11, 12]. By using segmented 
electrodes to control the shape of the VTA, the stimulation field delivered would be better fitted to the 
anatomy of the therapeutic target. Based on a computational model developed by Keane et al, smaller 
directionally segmented electrodes demonstrated superior targeting of the cerebello-thalamo-cortical 
pathway, especially in cases of misaligned DBS leads[13]. Modelling also suggests that segmentation 
of the electrode allows for an increase in magnitude of the activating function and electrode impedance 
while lowering the required stimulation intensity; thus, creating a greater radial distance of the VTA 
when compared to standard electrodes [8, 11]. Shaping the VTA with respect to the position of the 
electrode segment and target structure allows for more selective control of the stimulation field which 
may yield improved therapeutic outcomes for some patients. In DBS, the target areas, the STN, Vim 
and Gpi for PD, tremor and dystonia respectively, have a restricted size within these functional 
structures that are associated with effective treatment. Figure 1 depicts a relative illustration of the DBS 
targets and the target areas within anatomic structures associated with effective treatment. 
 
Figure 1: DBS Targets[14] 
 
The side effects from recruiting unintended neural structures vary depending on the original target and 
placement of the DBS lead. The proximity of the surrounding structures that correspond to disabling 
side effects such as tonic muscular contraction, dysarthria conjugate eye deviation, paresthesia or gait 
imbalance make it difficult to target the specific areas without the introduction of adverse effects. It has 
also been reported that spillover of stimulation to non-motor portions of the subthalamic nucleus may 
induce behavioral impairment and limbic side effects such as depression and impulsivity. DBS in the 
Vim that spans to adjacent structures can induce paresthesia side-effects by stimulating neurons within 
the sensory pathway of the ventral caudal (Vc) nucleus of thalamus. To date, physicians utilize 
electrode placement and stimulation parameter settings to control the stimulation delivered to the 
appropriate anatomic areas. Finite element modeling using actual patient anatomy has been studied to 
understand the electric field generated by DBS electrodes and its correlation to the volume of tissue 
activated. Standard DBS electrodes provide stimulation by dispersing current axially and symmetrically 
around the activated contacts (Figure 2). Because of this dispersion, the volume of tissue activated 
(VTA) by the stimulation prevents the excitation of neuronal tissue in a defined direction. 
 

 
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Figure 2: Finite element model comparison of (A) omnidirectional stimulation versus (B) unidirectional 
stimulation using segmented electrodes 
 
These models have led to an understanding of the occurrence of side effects associated with lead 
placement and electrode size or configuration. Specifically, given the radial dispersion of current, a high 
level of precision is necessary in placement to assure an effective therapeutic range [7, 14]. Clinical 
studies have further bolstered that accurate placement of DBS leads is correlated to the best clinical 
efficacy [15, 16]. Further, limitations in the current electrode size, translates to an inability to sculpt the 
shape and size of the VTA resulting in inadequate activated tissue volumes or inaccurate targeting of 
therapeutic regions [15, 10, 12]. 
 
In addition to current design limitations of existing DBS electrodes, post-operative migration of the lead 
can result in decreased clinical benefit of DBS. In cases of clinically relevant migration, the physician is 
afforded two options: 1) reprogramming and 2) additional surgery to relocate the lead to an adequate 
area. With current lead designs, reprogramming is limited due to the finite size of the therapeutic brain 
target or inability to shape the field due to the lead design [17]. More often than not, additional surgery 
is required to reposition the lead to regain adequate stimulation coverage. Additional surgery resulting 
from DBS lead misplacement or migration may be minimized through the use of a lead that allows for 
directional control of the current. The 8 channel SJM lead incorporates the concept of segmentation 
and directionality to allow for flexibility of reprogramming, compensating for loss of stimulation at the 
optimal brain target. The 8 channel lead will provide multiple avenues for redirecting the stimulation 
through sculpting the electric field and controlling the VTA. Directional DBS (dDBS) models have shown 
that current steering can activate different proportions of neural populations without surgically modifying 
the position of the electrode. Additionally, implantation of leads with a larger number of small surface 
area contacts could also help focus stimulation on the intended target resulting in finer control over the 
VTA [14]. 
 
DBS provides an opportunity for significant symptom relief and quality of life improvement with clinically 
acceptable risk. The 8 channel Infinity™ DBS System including leads, extensions, and the related 
accessories demonstrate the same safety and efficacy profile as the SJM currently marketed DBS 
Systems. Numerous publications with similar DBS systems and the market experience associated with 
the currently marketed SJM DBS system demonstrate the safety and performance of the equivalent 8 
channel DBS leads, extensions and related accessories for treatment of Parkinson’s disease, dystonia, 
and tremor.  
 
The efficacy of the use of directional DBS (dDBS) for the treatment of patients with movement disorders 
is supported with data from 2 prospective single center acute clinical studies.  Pollo et al (2014) 
conducted a prospective, single center acute study to assess the effectiveness of dDBS in PD and 

 
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tremor patients [15].  Compared to omnidirectional mode, the directional stimulation in the best direction 
was 41.3% wider with a therapeutic current necessary to produce meaningful stimulation that was 43% 
lower. The benefit of having a wider window for therapeutic stimulation allows for expanded 
programming options, especially in cases of lead migration or brain shift, without a need for surgical 
intervention to regain therapeutic benefit. No adverse events were observed during the implantation of 
and stimulation using the dDBS lead. 
 
An acute evaluation of a dDBS lead was also conducted by Contarino et al (2014) [18].  Directional 
stimulation proved effective in this study in that it reduced the appearance of side effects; while, 
widening the therapeutic window by redirection of the field of stimulation away from the anatomical 
structures responsible for the unwanted stimulation effects. No unexpected adverse events were 
observed during the implantation of and stimulation using the dDBS lead. 
 
The purpose of this post market clinical follow up (PMCF) study is to support the chronic clinical 
performance of the Infinity DBS IPG, leads, extensions and related system components. In addition, the 
study is to demonstrate that the 8 Channel leads and IPGs will allow the implanter to gain better control 
over the stimulation field as well as to expand the available programming options. 
 
A sub-set of subjects enrolled in this study will be used to meet the Post Market Clinical Follow-Up 
(PMCF) requirement for CE mark. Once this sub-set of patients is enrolled and followed for 12 months 
and have evaluable endpoint data at the 3-month follow-up visit, a report will be submitted indicating 
completion of this requirement. 
 
  RISKS AND BENEFITS OF THE CLINICAL STUDY 
There are no additional anticipated risks associated with the use of the Infinity system than from those 
identified for currently available DBS systems. 
 
3.1 
DESCRIPTION OF SUBJECT POPULATION 
Subjects who have a diagnosis matching the approved indication (Parkinson’s disease) and are being 
considered for a DBS implant with leads placed at the Subthalamic Nucleus (STN), or who have been 
implanted with an Infinity system for Parkinson’s disease with leads placed at the STN, comprise the 
target population for this study.  Subjects who meet all of the inclusion criteria and none of the 
exclusion criteria, and who have signed a statement of informed consent approved by an Ethics 
Committee (EC) or Institutional Review Board (IRB), will be enrolled in the study.  
3.2 
ANTICIPATED CLINICAL BENEFITS 
The Infinity system with the directional lead provides additional programming options not available in 
other market-approved DBS systems.   
 
If patients agree to take part in this study, there may or may not be direct medical benefits to the 
individual patient.  The scientific use of the data, which is gathered from this study, may help 
researchers discover better ways of programming DBS patients and improving quality-of-life. 
3.3 
ANTICIPATED ADVERSE EVENTS AND ADVERSE DEVICE EFFECTS 
Deep brain stimulation potentially has the following adverse effects: 

 
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Possible surgical complications. Surgical complications include, but are not limited to, the following: 
intracranial hemorrhage (which can lead to stroke, paralysis, or death); subcutaneous hemorrhage or 
seroma; hematoma; cerebrospinal fluid leakage or cerebrospinal fluid abnormality; brain contusion; 
infection or inflammation; antibiotic anaphylaxis; skin disorder; edema; persistent pain at surgery site or 
IPG site; erosion; brachial plexus injury (nerves to chest, shoulder and arm); postoperative pain, stress, 
or discomfort; neuropathy (nerve degeneration); hemiparesis (muscular weakness or partial paralysis 
on one side of body); ballism or hemiballism (uncontrollable movements on both or only one side of the 
body); confusion—transient, nocturnal or ongoing; cognitive impairment, including delirium, dementia, 
disorientation, psychosis and speech difficulties; aphasia; deep vein thrombosis; complications from 
anesthesia; phlebitis (vein inflammation); pulmonary embolism (sudden blood vessel obstruction); 
aborted procedures (air embolism, unable to find target, surgical complication, etc.); complications from 
unusual physiological variations in patients, including foreign body rejection phenomena; pneumonia, 
seizure or convulsions; paralysis (loss of motor function, inability to move); stroke and death.  
 
Possible deep brain stimulation complications. Deep brain stimulation complications 
include, but are not limited to, the following:  
 
Device-related complications  
- Undesirable changes in stimulation related to cellular changes in tissue around the electrodes, 
changes in the electrode position, loose electrical connections, or lead fracture  
- Loss of therapeutic benefit as a result of change in electrode positions, loose electrical connections, or 
lead or extension fracture  
- Initial jolt or tingling during stimulation; jolting or shocking sensations  
- Infection  
- Paresthesia  
- Lead fracture, migration, or dislodgement  
- Misplaced lead  
- Extension malfunction, fracture, or disconnect  
- Deep brain stimulation system failure or battery failure within the device  
- Deep brain stimulation system malfunction or dislodgement  
- Spontaneous turning on or off of the IPG  
- Allergic or rejection response to implanted materials  
- Persistent pain, tightness, or redness at the incision sites or general pain  
- General erosion or local skin erosion over the IPG  
- Persistent pain, tightness, or discomfort around the implanted parts (e.g., along the extension path in 
the neck)  
- Impaired wound healing (e.g., incision site drainage) or abscess formation  
- Additional neurosurgical procedure to manage one of the above complications or to replace a 
malfunctioning component  
Stimulation-related complications or other complications  
- Worsening of motor impairment and Parkinson’s disease symptoms including dyskinesia, rigidity, 
akinesia or bradykinesia, myoclonus, motor fluctuations, abnormal gait or incoordination, ataxia, 
tremor, and dysphasia  
- Paresis, asthenia, hemiplegia, or hemiparesis  
- Dystonia  
- Sensory disturbance or impairment including neuropathy, neuralgia, sensory deficit, headache, 
and hearing and visual disturbance  
- Speech or language impairment including, aphasia, dysphagia, dysarthria, and hypophonia  

 
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- Cognitive impairment including attention deficit, confusion, disorientation, abnormal thinking, 
hallucinations, amnesia, delusions, dementia, inability to act or make decisions, psychic akinesia, 
long term memory impairment, psychiatric disturbances, depression, irritability or fatigue, mania or 
hypomania, psychosis, aggression, emotional lability, sleep disturbance, anxiety, apathy, drowsiness, 
alteration of mentation, postural instability and disequilibrium  
- Restless leg syndrome  
- Supranuclear gaze palsy  
- Hypersexuality or increased libido  
- Decreased therapeutic response  
- Urinary incontinence or retention  
- Diarrhea or constipation  
- Cardiac dysfunction (e.g., hypotension, heart rate changes, or syncope)  
- Difficulty breathing  
- Increased salivation  
- Weight gain or loss  
- Eye disorder including eye apraxia or blepharospasm  
- Nausea or vomiting  
- Sweating  
- Fever  
- Hiccups  
- Cough  
- Cramps  
- Worsening existing medical conditions 
3.4 
RESIDUAL RISKS ASSOCIATED WITH THE DEVICE UNDER INVESTIGATION, AS 
IDENTIFIED IN THE RISK ANALYSIS REPORT 
DBS refers to the electrical stimulation of structures deep within the brain. DBS is considered an 
effective treatment for Parkinson’s disease, tremor and dystonia that is reversible, and adaptable.  
The targeted study population consists of subjects who have been implanted with or are being 
considered for implant of an Infinity DBS system.  Standard outcome measures will be used to evaluate 
Parkinson’s disease symptoms. 
Effects of the DBS are considered safe, non-destructive and reversible. The frequency and severity of 
procedural risks and complications related to the implant of the Infinity system are expected to be 
similar to those that are cited in the current literature. 
3.5 
RISKS ASSOCIATED WITH PARTICIPATION IN THE CLINICAL STUDY 
There are no study-related additional risks expected within this study. 
3.6 
POSSIBLE INTERACTIONS WITH CONCOMITANT MEDICAL TREATMENTS AND/OR 
CONCURRENT MEDICAL INTERVENTIONS 
Diathermy therapy is contraindicated for subjects who have been implanted with the Infinity system. Do 
not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now 
referred to as diathermy) on subjects implanted with a neurostimulation system. Energy from diathermy 
can be transferred through the implanted system and can cause tissue damage at the location of the 
implanted electrodes, resulting in a severe injury or death. Diathermy is further prohibited because it 
may also damage the neurostimulation system components. This damage could result in loss of 
therapy, requiring additional surgery for system replacement. Injury or damage can occur during 

 
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diathermy treatment whether the neurostimulation system is turned on or off. All subjects are advised to 
inform their healthcare professional that they should not be exposed to diathermy treatment. 
Magnetic resonance imaging (MRI) may be contraindicated for subjects implanted with the Infinity 
system. If the Infinity system has MRI Conditional labelling, MRI may be performed with imaging 
settings descried in Abbott’s DBS MRI Procedures Manual. If the Infinity system does not have MRI 
Conditional labelling, do not use a full body radiofrequency (RF) coil or other extremity coils on subjects 
implanted with a neurostimulation system. Because energy from MRI can be transferred through the 
implanted system, the potential for heat generation at the location of the electrodes exists. This isolated 
temperature rise may cause tissue damage at the location of the implanted electrodes, possibly 
resulting in severe injury or death. Injury can occur during MRI treatment whether the neurostimulation 
system is turned on or off. Patients with a neuromodulation system that does not have MRI Conditional 
labelling are advised to inform their healthcare professional that they should not be exposed to MRI. 
Please refer to the Infinity IPG clinician manual/instructions for use regarding warnings and 
precautions.  
3.7 
STEPS THAT WILL BE TAKEN TO CONTROL OR MITIGATE THE RISKS 
There are no study-related additional risks expected within this study. 
3.8 
RISK-TO-BENEFIT RATIONALE 
There are no study-related additional risks expected within this study. 
3.9 
DESCRIPTION OF HISTORY OF MODIFICATIONS OR RECALL IN RELATION TO SAFETY 
AND CLINICAL PERFORMANCE FOR DEVICE UNDER INVESTIGATION 
This is a newly approved device and no device modifications have been reported to date.  No device 
recalls have been issued concerning this product. 
 
 STUDY DESIGN 
4.1 
PURPOSE 
The purpose of this post market study is to characterize the clinical performance of the Infinity DBS 
system including IPG, leads, extensions and related system components. 
 
The PMCF requirement for this study will be to demonstrate superiority of directional stimulation 
compared to omnidirectional stimulation, as measured by therapeutic window. The primary endpoint will 
be evaluated for the first 66 subjects who complete the 12-month follow-up visit and have evaluable 
primary endpoint at the 3-month follow-up visit. 
 
4.2 
STUDY DESIGN AND SCOPE 
This study is a post-market clinical follow-up study designed as a prospective, blinded-subject, blinded-
evaluator, observational, multi-center evaluation of the Infinity DBS system.  The clinical study will be 
conducted in up to 60 centers from the European Union, United States, Latin America, and Australia.   
 
The clinical investigation has been designed to involve as little pain, discomfort, fear, and any other 
foreseeable risk as possible for subjects. Refer to the Risks Analysis section of this clinical investigation 
plan for details.  

 
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Subjects who currently have an Infinity DBS system or have been recommended by the investigator for 
implantation of a DBS system and meet the standard requirements will be approached to participate in 
the study.  Each subject will be screened according to the inclusion/exclusion criteria.  If the subject 
meets all of the study inclusion criteria and none of the exclusion criteria, the subject will be informed 
about the study to determine if the subject is interested in participating. Baseline data may be collected 
from the subject’s medical record.  After the subject signs the informed consent and is enrolled in the 
study, the subject will undergo an Infinity DBS system implant if the Infinity DBS system is not already 
implanted. 
 
During the surgery, the leads will be implanted according to the physician’s standard operating 
procedures. The neurosurgeon will be instructed to implant the hourglass-shaped radiopaque marker 
facing posterior or toward the implanter during insertion (toward the back of the subject’s head) so that 
contact/segments are easily identifiable. The orientation of the contacts will be collected.  In addition, 
neurosurgeons will be instructed to plan placement to target between contacts 2 and 3.  A pre-operative 
and post-operative image (Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT)) will 
be obtained to assist with lead location data.  The IPG will be activated according to the site’s standard 
of care and will be programmed by trained personnel using the Clinician Programmer.  The subject may 
be given a Patient Controller, dependent on the physician’s recommendation for patient care.  Subjects 
will return for evaluation 3, 6, and 12 months post-initial programming for follow-up visits. An optional 
long-term follow-up will collect additional information 24 months after initial programming, optionally by 
telephone, and at a 36-month follow-up visit. This study is for data collection purposes and there are no 
additional risks to patients who participate in this study other than those risks of having a deep brain 
stimulation system implanted. 
 
A comparison of the therapeutic window using directional stimulation to the therapeutic window using 
omnidirectional stimulation will be performed for each lead on each subject. Subjects will be considered 
to have a greater therapeutic window with direction stimulation if one or both leads has a larger 
therapeutic window with directional stimulation than omnidirectional stimulation. 
 
A blinded evaluator will be used in this study to minimize study bias. The blinded evaluator will assess 
the therapeutic window for each subject at initial programming, the 3-month visit and the 12-month visit.  
The UPDRS part III motor examination for each subject will also be assessed by the blinded evaluator 
at the 3-month and 6-month visits. The blinded evaluator will not be aware of the subject’s 
programming or device settings at the time of the evaluation. In addition, subjects will be unaware of 
their programmed parameters for the first 6 months. 
 
All serious adverse events (SAEs), serious procedure-related events (and procedure-related AEs 
lasting longer than 30 days) and device-related adverse events will be recorded throughout the 
subject’s participation in the study. 
 
The total duration of the study is expected to be 60 months. 
4.2.1 
Number of subjects required to be included in the study  
Up to 350 subjects will be enrolled in the study (refer to section 12.0).   
 
A subset of subjects enrolled in this study will be used to meet the Post-Market Clinical Follow-Up 
(PMCF) requirement for CE mark. Once this subset of subjects is enrolled and followed for 12 months 

 
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and have evaluable primary endpoint data at the 3-month follow-up visit, a report will be submitted 
indicating completion of this requirement.  The primary endpoint analysis will be performed when 66 
subjects have completed 12 months of follow-up and have evaluable primary endpoint data at the 3-
month follow-up visit. 
 
4.2.2 
Estimated time needed to enroll this subject population 
The study may continue up to five (5) years dependent on the rate of enrollment. 
 
4.3 
OBJECTIVES 
4.3.1 
Primary Objective 
Demonstrate superiority of the directional lead DBS therapeutic window to the omnidirectional lead 
DBS therapeutic window. 
 
4.3.2 
Secondary Objective 
Demonstrate non-inferiority of the directional lead DBS therapeutic window to the omnidirectional lead 
DBS therapeutic window and comparison of UPDRS part III motor examination scores at 3 and 6 
months to evaluate therapeutic differences in omnidirectional vs directional stimulation. 
4.4 
ENDPOINTS 
4.4.1 
Primary Endpoint 
The proportion of subjects for which at least one lead’s therapeutic window (evaluated by a blinded 
evaluator) is greater using directional stimulation than omnidirectional stimulation, tested against a 
performance goal of 60%, at the 3-month follow-up visit.  The directional segment with the widest 
therapeutic window will be compared to omnidirectional stimulation. 
 
4.4.2 
Secondary Endpoint 
If primary endpoint not met, the proportion of subjects with a therapeutic window (evaluated by a 
blinded evaluator) which is larger under directional stimulation than omnidirectional stimulation tested 
against a performance goal of 40% at the 3 month follow-up visit; Comparison of 3-month vs. 6-month 
UPDRS part III motor examination scores (evaluated by a blinded evaluator) to assess omnidirectional 
vs. directional stimulation. 
 
4.4.3 
Descriptive Endpoints 
The following data will be collected: 
Evaluation of subject and clinician stimulation preference at 6-month follow-up visit; 
Change in therapeutic effectiveness measured by UPDRS part III motor examination at the 12-month 
follow-up visit from baseline visit; 
Change in ADLs as determined from the UPDRS part II ADLs at the 3-, 6-, and 12-month follow-up 
visits from baseline visit; 
Change in quality-of-life as measured by the PDQ-39 at the 3-, 6-, and 12-month follow-up visits from 
baseline visit; 
Evaluation of device-related adverse events; 
Evaluation of subject and programmer satisfaction with product usability at the 12-month follow-up visit. 
Comparison of mean values of therapeutic window with directional and omnidirectional stimulation; 

 
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Current (amplitude) at which first sustainable side effect is observed with directional and 
omnidirectional stimulation; 
Current (amplitude) at which first sustainable stimulation-induced side effect is observed with directional 
and omnidirectional stimulation; 
Minimum therapeutic current with directional and omnidirectional stimulation; 
Optimal therapeutic current with directional and omnidirectional stimulation; 
Total amount of time required for programming and each study visit. 
Long-term outcomes evaluated by change compared to baseline in UPDRS part III motor examination, 
UPDRS part II ADLs and PDQ-39, at the 36-month follow-up visit. 
 
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 an 
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 
1) Subject is able to provide informed consent; 
2) Subject is diagnosed with Parkinson’s disease (PD) and has been recommended to receive an 
Infinity DBS system with a bilateral DBS implant in the Subthalamic Nucleus (STN), or has received 
an implant of an Infinity system with bilateral lead implants in the STN; 
3) Subject must be available for follow-up visits. 
 
A subject is not eligible for clinical study participation if the subject meets any of the following exclusion 
criteria: 
 
4.5.2 
Exclusion Criteria 
1) Subject is not a surgical candidate; 
2) In the investigator’s opinion, the subject is unable to tolerate multiple programming sessions within 
a single setting; 
3) Subject is unable to comply with the follow-up schedule. 
 
 
4.6 
SUBJECT POPULATION 
4.6.1 
Subject Screening 
All subjects presenting at the investigational site can be screened by a member of the investigational 
team previously trained on the CIP and delegated to do so. 
 

 
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Subjects who do not meet the inclusion/exclusion criteria will not be eligible to participate in this study. 
 
Subjects meeting the inclusion/exclusion criteria will be fully informed about the study and asked to 
participate in the study. In case the subject agrees, a duly signed and dated Patient Informed Consent 
will be obtained. 
 
4.6.2 
Point of Enrollment 
Subjects are considered enrolled in the study from the moment the subject has provided written Patient 
Informed Consent. (Refer to section 4.7 for the informed consent process). Although subjects exit the 
study after completion of the 12-month visit, subjects who provide written informed consent by signing 
the informed consent addendum for long-term follow-up may participate in 24- and 36-month follow-up 
visits.Follow-up visits will be scheduled based on date of initial programming.  
 
4.6.3 
Enrollment of Medicare Beneficiaries 
In the United States, subjects enrolled in the clinical study are expected to be consistent with the 
Medicare population based on age and as such, the study results are expected to be generalizable to 
the Medicare population. 
 
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 
required to provide informed consent, as required by applicable regulations and the center’s EC or IRB.  
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 an 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 EC or IRB.  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 EC or IRB consistent with the center’s EC or IRB reporting 
requirements.  

 
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 DEVICE UNDER INVESTIGATION AND CONTROL/COMPARATORS (IF APPLICABLE) 
5.1 
DEVICE DESCRIPTION 
Infinity DBS system:  
 
In this study, commercially available St. Jude Medical (SJM) Infinity DBS system components will be 
used.  This neurostimulation system is designed to deliver electrical stimulation to targets in the brain. 
The neurostimulation system includes the following primary components:  
 
• 
Implantable pulse generator (IPG)  
• 
Leads  
• 
Extensions  
• 
Clinician programmer  
• 
Patient controller  
 
The IPG connects to the implanted extensions, which connect to the leads implanted in the brain. The 
IPG delivers electrical pulses through the extensions and leads to electrodes at a selected target in the 
brain in order to provide therapeutic stimulation. The patient magnet can turn the IPG on and off, if the 
physician enabled this functionality. Physicians use the clinician programmer to create and modify a 
program for a patient. Patients use the patient controller to control their prescribed programs. 
Components of the Infinity DBS system and model numbers are included in Appendix D. 
 
Infinity Implantable Pulse Generator 
This IPG is an electronic device designed to be connected to one or two extensions. It is powered by a 
hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate 
constant-current electrical stimulation. The IPG is conductive on all sides, which allows the IPG case 
(also called a “can”) to be used as an anode for monopolar stimulation. The IPG communicates 
wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to 
accommodate different power needs. The IPG can receive software upgrades after implantation to 
provide patients with additional features as approved by the respective regulatory agencies. To 
upgrade features on the IPG, a system programmer is needed.  
 
Leads 
St. Jude Medical DBS leads are designed for introduction into the brain using standard stereotactic 
neurosurgical techniques.  Leads feature electrodes on a stiff distal end with an inactive lead tip. The 
proximal end of the lead contains contact bands that correspond with each of the distal electrodes and 
an inactive band that functions as a contact for a setscrew when connecting to a compatible extension. 
Additionally, the leads have colored bands that can help during implantation to differentiate between the 
right and left sides of the body. Two types of leads are available: 4 channel and 8 channel. The 4-
channel leads contain cylindrical electrodes that provide stimulation in all directions around the lead. 
The 8-channel leads contain cylindrical and segmented electrodes. The segmented electrodes can be 

 
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activated independently to focus stimulation in one direction to help exclusively target desired 
neurological structures. 
 
Extensions 
St. Jude Medical DBS extensions are designed to connect the lead to the IPG. One end of the 
extension is designed to receive the proximal end of the lead, and the opposite end of the extension is 
designed for insertion and connection with the IPG. 
 
Clinician Programmer 
The Clinician Programmer Application is a software application running on an iPad which is used by a 
clinician to wirelessly connect to Infinity IPGs to establish or modify a patient’s stimulation prescription.  
 
Patient Controller 
The Patient Controller is a component of the Infinity system. It is an off-the-shelf touch screen device 
(iPod Touch) with SJM-designed mobile Application Software. 
 
5.2 
DEVICE HANDLING AND STORAGE 
Only regulatory approved and commercially available shelf-stock will be used within commercially 
approved indications for the investigation.  No specific device traceability is required. 
 
 

 
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 PROCEDURES 
6.1 
STUDY FLOW CHART 
Subjects may be enrolled after device implant 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Initial Programming 
According to site standard of care - Omnidirectional 
Implant 
Infinity System Implantation  
Product & Procedure details recorded 
  
Enrollment/Baseline  
Eligibility Inclusion/Exclusion Criteria Confirmed/Informed 
consent signed 
Baseline/Medical Record Data Collection 
Baseline evaluations and information 
  
  3 Month Visit 
Subject questionnaires/evaluations completed 
Detailed programming evaluation – Omnidirectional and 
Directional lead assessment 
Programming details recorded 
 12 Month Visit 
Subject questionnaires/evaluations completed 
Detailed programming evaluation – Omnidirectional and 
Directional lead assessment 
Programming details recorded 
  
  6 Month Visit 
Subject questionnaires/evaluations completed 
Programming details recorded 
Optimize programming if needed  
24 Month Visit  
(optionally by telephone) 
Adverse events  
36 Month Visit 
Subject questionnaires/evaluations completed 
Detailed programming evaluation – Omnidirectional and 
Directional lead assessment 
Programming details recorded 
Exit study 
  

 
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6.2 
STUDY VISITS 
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 or 
IRB 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 
Implant  
Initial Programming   
site standard of 
care – 
Omnidirectional  
(Day 0)*** 
3 Month  
3 months + 30 days 
since Initial 
Programming –
Directional  
6 Month   
6 months +30 days  
since  Initial 
Programming 
12 Month            
12 months + 60 
days  since  Initial 
Programming 
24 Month   
24 months +90 days  
since  Initial 
Programming 
36 Month   
36 months +90 days  
since  Initial 
Programming 
Inclusion/Exclusion 
Criteria check 
X 
 
 
 
 
 
 
 
Informed Consent 
Process 
X 
 
 
 
 
 
 
 
Subject Demographics 
X 
 
 
 
 
 
 
 
Parkinson’s Disease 
History 
X 
 
 
 
 
 
 
 
Parkinson’s Disease 
Medication Current 
X 
 
 
 
 
X 
 
X 
UPDRS Section II and III 
Off Medication 
X 
 
 
 
 
 
 
 
UPDRS Section II and III 
On Medication 
X 
 
 
 
 
 
 
 
UPDRS Section II (On 
Med On Stim) 
 
 
 
X 
X 
X 
 
X 
UPDRS Section III (Off 
Medication / On Stim) 
 
 
 
X* 
 
X 
 
X 
UPDRS Section III (Off 
Medication /  Off Stim 
 
 
 
X* 
 
X 
 
X 
UPDRS Section III (On 
Med On Stim) 
 
 
 
X* 
X* 
X 
 
X 
UPDRS Section III (On 
Med Off Stim) 
 
 
 
 
X* 
X* 
X 
 
X 
PDQ-39 
X 
 
 
X 
X 
X 
 
X 
Implant Information 
 
X 
 
 
 
 
 
 
Pre- and Post-Operative 
Image Collected 
 
X 
 
 
 
 
 
 
Initial testing/ 
programming 
data/session data 
 
 
X* 
 
 
 
 
 
Subject Preference 
 
 
 
 
X** 
 
 
 
Clinician Preference 
 
 
 
 
X 
 
 
 

 
Study Document No: SJM-CIP-10061 Ver. G 
Study Name: PROGRESS 
Clinical Investigational Plan 
 
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 *Blinded Evaluation 
** Blinded Subject 
 
 (X) if applicable 
   ***For subjects implanted with the Infinity DBS System at the time of enrollment, “Day 0” will be 
the date of consent. 
 
Baseline and implant information may be retrospectively collected from the subject’s medical records 
after enrollment. 
 
Informed Consent Procedure and Inclusion/Exclusion Criteria:  
Patient’s eligibility criteria will be evaluated and informed consent will be obtained at the 
Baseline/Enrollment visit.  
 
Subject Demographics:  
Subject’s Age, Weight, Height and Gender will be collected at the Baseline visit.  
 
Parkinson’s Disease History:  
Subject’s year of symptom onset, year of initial diagnosis, length of diagnosis, subject’s impression of 
worst symptom, will be collected at the Baseline visit.  
 
Parkinson’s Disease Medication: 
Subject’s current medications for PD will be collected at the Baseline visit, at the 12-month and 36-
month follow-up visits. 
 
Subject Data:  
Baseline PDQ-39, UPDRS part II ADLs and part III motor examination scores may be collected from 
the subject’s medical record. PDQ-39, UPDRS part II ADLs On Medication/On Stimulation, and UPDRS 
part III motor examination On Medication and On and Off Stimulation will be collected at 3, 6,12 and 36 
Month Follow-Up visits. UPDRS part III Off Medication will also be collected at 3-, 12-, and 36-month 
                 
                     Visit 
 
 
 
 
Study Activity 
Enrollment 
Baseline 
Implant  
Initial Programming   
site standard of 
care – 
Omnidirectional  
(Day 0)*** 
3 Month  
3 months + 30 days 
since Initial 
Programming –
Directional  
6 Month   
6 months +30 days  
since  Initial 
Programming 
12 Month            
12 months + 60 
days  since  Initial 
Programming 
24 Month   
24 months +90 days  
since  Initial 
Programming 
36 Month   
36 months +90 days  
since  Initial 
Programming 
System Usability Scale 
(SUS) Subject 
 
 
 
 
 
X 
 
 
System Usability Scale 
(SUS) Programmer 
 
 
 
 
 
X 
 
 
Device Testing/ 
Programming data 
/session data 
 
 
 
X* 
X 
X* 
 
X 
Adverse Event Check 
 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
System Revision Check 
 
 
 
(X) 
(X) 
(X) 
 
(X) 
Deviation 
 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
Termination/Exit 
 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 
(X) 

 
Study Document No: SJM-CIP-10061 Ver. G 
Study Name: PROGRESS 
Clinical Investigational Plan 
 
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or used without the express written consent of St. Jude Medical 
follow-up visits. In addition, subject/programmer satisfaction and data device usage will be collected at 
the 12-Month Follow-Up visit. 
 
Unified Parkinson’s Disease Rating Scale/Section II and Section III:  
In order to assess the subject’s activities of daily living and Parkinson’s disease symptoms, Section II 
and III of the UPDRS questionnaire will be completed at Baseline, 3-, 6-, 12- and 36-Month Follow-Up 
visits. 
The UPDRS is a rating tool to follow the longitudinal course of Parkinson’s disease. It is made up of the 
following sections: I) Mentation (mental status), Behavior, and Mood, II) Activities of Daily Living (ADL), 
III) Motor sections and IV) Complications of Therapy, which are evaluated by interviewing the patient.  
All responses are rated on a 0 to 4-point scale where 0 indicates ‘none’ and 4 indicates ‘severe’ 
symptom. 
 
Parkinson’s Disease Questionnaire: 
In order to assess the subject’s quality of Life the PDQ-39 will be completed at Baseline, 3-, 6-, 12- and 
36-Month Follow-Up visits.  The PDQ-39 is a disease specific instrument designed to measure aspects 
of health that are relevant to patients with PD, and which may not be included in general health status 
questionnaires. The PDQ-39 is a self-administered questionnaire, which comprises 39 items 
addressing eight domains of health that patients consider to be adversely affected by the disease. 
 
Implanted System Information:  
Information regarding the implanted system will be collected during the permanent implantation 
procedure and in case of additional surgery or from the medical records if patient was already 
implanted with the Infinity System.  
 
Programming Interrogation/Data:  
Programming data and parameters, including program impedance, will be collected during initial 
programming, at the 3-, 6-, 12- and 36-Month Follow-Up visits. Device session data should be sent to 
the Sponsor.  
 
Evaluation of Programming/Device Testing: 
Detailed device testing will be done at the Initial programming, 3-month follow-up visit, 12-month follow-
up visit and 36-month follow-up visit. 
 
System Usability Scale/SUS:  
In order to assess the subjects and site programmer’s use of the system, a System Usability Scale 
(SUS), a simple, ten-item scale giving a global view of subjective assessments of usability will be 
completed by the subject and programmer at the 12 Month Follow-Up visit. 
 
Adverse Events:  
Please refer to Section 8.0 of this protocol. 
 
6.3 
ENROLLMENT VISIT  
The following enrollment activities are performed after the subject has been screened and must occur 
before any study evaluation /visit. 
• 
The principal or delegated investigator is responsible for screening all potential patients to 
determine patient eligibility for the study.  

 
Study Document No: SJM-CIP-10061 Ver. G 
Study Name: PROGRESS 
Clinical Investigational Plan 
 
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• 
If a patient meets all inclusion criteria and does not meet any of the exclusion criteria, the patient is 
eligible for the study.  
• 
The patient is enrolled in the study when the patient signed the  EC- or IRB-approved consent form.  
 
Site personnel should record enrollment information (name of the study, date of consent and 
Inclusion/exclusion information) from the hospital records and complete the Enrollment form 
electronically in a timely manner (preferably within 5 days after enrollment).  
 
Beginning when the patient signs the Patient Informed Consent form, AEs must be reported according 
to the guidelines mentioned in this CIP.  
 
In case the subject was consented to participate in the study, but does not meet inclusion/exclusion 
criteria, and was not implanted, the subject should be withdrawn and a withdrawal form must be 
completed. The patient will resume regular standard of care with the patient’s physician.  
In case the subject was consented to participate in the study and was implanted but does not meet 
inclusion/exclusion criteria, then this is considered a protocol violation. A protocol deviation form needs 
to be completed and the Sponsor must be informed. The EC or IRB and Competent Authority, if 
applicable, should be notified appropriately about any deviations with regard to the violation of 
inclusion/exclusion criteria. 
 
6.4 
BASELINE VISIT 
The following information will be collected at the baseline visit (baseline data can be collected on the 
same day as enrollment/informed consent).  Baseline information can be retrospectively collected from 
the subject’s medical records after enrollment: 
Demographics 
Parkinson’s disease history and medication 
 
The following may be collected retrospectively from the subject’s medical record.  The retrospective 
data should be collected from the most recent assessments completed prior to the implant date but not 
greater than 12 months prior:   
• 
UPDRS Off and On Medication – Most recently documented UPDRS 
• 
PDQ-39 – Most recently documented PDQ-39 
 
6.5 
IMPLANT/PROCEDURE 
Subjects will be permanently implanted with the Infinity™ neuromodulation system according to 
standard operating procedures. It is suggested that the neurosurgeon implant the hourglass shaped 
radiopaque marker facing posterior or toward them during insertion (toward the back of the subject’s 
head) so that contact/segments are easily identifiable. The orientation of the contacts will be collected.  
In addition, neurosurgeons will be instructed to plan placement to target between contacts 2 and 3.   A 
pre-operative and post-operative image (MRI/CT) will be obtained to capture lead location data.  
Subjects will receive a patient programmer if the physician does this as part of his standard of care and 
will be instructed on the use of the system.  Subjects will be unaware of their programmed parameters 
for the first 6 months. 
 
Following system implantation, the stimulator will be activated and programmed by trained personnel in 
accordance with the physician’s and hospital’s standard operating procedures.  
 

 
Study Document No: SJM-CIP-10061 Ver. G 
Study Name: PROGRESS 
Clinical Investigational Plan 
 
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The following information will be collected at the Implantation visit (implant information can be 
retrospectively collected from the subject’s medical records if enrollment occurs after implant): 
Lead/extension and IPG data  
Pre-operative and post-operative images 
AE and/or protocol deviation (if applicable) 
 
6.6 
SCHEDULED FOLLOW-UPS 
Blinded Evaluation 
 
A blinded evaluator will be used in this study to minimize study bias.  The blinded evaluator will assess 
the therapeutic window for each subject at the initial programming, the 3-month visit and at the 12-
month visit.  The UPDRS part III motor examination for each subject will also be assessed by the 
blinded evaluator at the 3-month and 6-month visits. This evaluator will not be aware of the subject’s 
programming or device settings.  It is recommended that the blinded evaluator assessing the 
therapeutic window and the UPDRS part III motor examination should be the same person; however, it 
is not required.  In addition, subjects will be unaware of their programmed parameters for the first 6 
months. 
 
Subjects are to be instructed not to take medication the night prior to or the morning of the study visit. 
This is defined as the Off Medication state. Upon taking appropriate medication, subject is considered 
to be in the On Medication state. 
 
Initial Programming (to be completed according to site’s standard of care) 
The following will be collected: 
• 
Monopolar review  
• 
AE and/or protocol deviation (if applicable). 
• 
Omnidirectional testing – Off Medication (See Evaluation of Programming) 
• 
Initial programming parameters – Sites will program each lead in an omnidirectional configuration to 
be used for the first 3 months. If omnidirectional stimulation does not provide adequate therapy or is 
not tolerated by the subject, any other programming is allowed. 
Initial programming information can be retrospectively collected from the subject’s medical records if 
enrollment occurs after implant. For these subjects, the omnidirectional testing by the programmer and 
blinded evaluator will be completed on the date of consent/enrollment.  
 
3-Month Follow-Up Visit (3 months ± 30 days since initial programming or consent date) 
The following information will be collected at the 3-month follow-up visit:  
• 
PDQ-39; 
• 
UPDRS part II ADLs On Medication / On Stimulation; 
• 
UPDRS part III motor examination Off Medication/Off and On Stimulation assessed by a blinded 
evaluator; 
• 
UPDRS part III motor examination On Medication/ Off and On Stimulation assessed by a blinded 
evaluator; 
• 
Omnidirectional testing – Off Medication (See Evaluation of Programming) 
• 
Detailed directional lead testing as tolerated by the subject – Off Medication (see Evaluation of 
Programming); sites are to program each lead to the optimal directional segment; 
• 
Programming parameters; device session data; 
• 
Unscheduled visits (if applicable); 

 
Study Document No: SJM-CIP-10061 Ver. G 
Study Name: PROGRESS 
Clinical Investigational Plan 
 
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• 
AE, system revision, and/or protocol deviation (if applicable). 
 
6-Month Follow-Up Visit (6 months ± 30 days since initial programming or consent date) 
The following information will be collected at the 6-month follow-up visit:  
• 
PDQ-39; 
• 
UPDRS part II ADLs On Medication / On Stimulation; 
• 
UPDRS part III motor examination On Medication/ Off and On Stimulation assessed by a blinded 
evaluator; 
• 
Programming parameters; device session data; 
• 
Subject and clinician preference; 
• 
Unscheduled visits (if applicable); 
• 
AE, system revision, and/or protocol deviation (if applicable). 
 
12-Month Follow-Up Visit (12 months ± 60 days since initial programming or consent date) 
The following information will be collected at the 12-month follow-up visit:  
• 
PDQ-39; 
• 
Patient SUS questionnaire 
• 
UPDRS part II ADLs On Medication / On Stimulation; 
• 
UPDRS part III motor examination Off Medication/Off and On Stimulation; 
• 
UPDRS part III motor examination On Medication/ Off and On Stimulation; 
• 
Omnidirectional and directional testing - Off Medication; 
• 
Programming parameters; device session data; 
• 
Programmer SUS questionnaire; 
• 
Unscheduled visits (if applicable); 
• 
Current Parkinson’s Disease medication; 
• 
AE, system revision, and/or protocol deviation (if applicable). 
 
24-Month Follow-Up Visit (24 months ± 90 days since initial programming) 
The following information will be collected at the 24-month follow-up visit:  
• 
AE and/or protocol deviation (if applicable). Adverse events will be reported on subjects who 
consent for participation in the long-term follow-up. The start date for reporting events will be the 
day of the previous PROGRESS follow-up visit, to ensure that all adverse events are reported. 
Adverse events will continue to be reported for the duration of the subject’s participation in the long-
term follow-up. 
 
The 24-month visit may be performed in person or by telephone, at investigator decision. If consent for 
the long-term follow-up occurs after window for the 24-month follow-up visit has passed, it will be 
considered a missed visit with no protocol deviation required. The subject will be scheduled for the 36-
month visit based on initial programming date. 
 
36-Month Follow-Up Visit (36 months ± 90 days since initial programming) 
The following information will be collected at the 36-month follow-up visit:  
• 
PDQ-39; 
• 
UPDRS part II ADLs On Medication / On Stimulation; 
• 
UPDRS part III motor examination Off Medication/Off and On Stimulation; 
• 
UPDRS part III motor examination On Medication/ Off and On Stimulation.  
• 
Omnidirectional and directional testing - Off Medication; 
• 
Programming parameters; device session data; 

 
Study Document No: SJM-CIP-10061 Ver. G 
Study Name: PROGRESS 
Clinical Investigational Plan 
 
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• 
Unscheduled visits (if applicable); 
• 
Current Parkinson’s Disease medication; 
• 
AE, system revision, and/or protocol deviation (if applicable). 
 
 
 
Evaluation of Programming/Device Testing:  
Device testing is to be completed with the subject in the Off Medication state.   
Subjects are to be instructed not to take their medication the night prior to or the morning of the study 
visit; or depending on the type of levodopa medication the subject is taking (i.e.; extended release or 
long acting) the investigator can use clinical judgement to determine an adequate length of time that the 
subject should be off medication prior to the testing. 
  
In order to minimize programming bias, each site will have a designated programmer and a 
designated blinded evaluator during the omnidirectional and directional device testing.  The 
blinded evaluator will be unaware of the specific program changes made to the device 
parameters during each testing.   
 
Initial Programming Visit 
Each site will perform their standard monopolar review of each lead to determine the best contact 
selection for the subject followed by: 
 
 
Omnidirectional Testing – Assessment of the contact that has been selected as providing the best 
clinical benefit.  Omnidirectional testing is defined as: 
• 
Any of the contacts on a 4 channel lead (1-4); or  
• 
All 3 segments (A, B, and C) are activated on contact 2 or 3 of the 8 channel lead; or 
• 
Contact 1 or 4 active on the 8 channel lead 
 
Each lead will be assessed by a blinded evaluator for first meaningful therapeutic effect followed by 
assessment of first sustainable side effects. 
 
As the amplitude is increased by the programmer, the therapeutic effect on the motor symptoms will be 
based on the blinded evaluator’s clinical judgement. 
First meaningful therapeutic effect will be determined by the blinded evaluator’s clinical judgement of 
the benefit seen for the subject’s primary motor symptoms (i.e.; first benefit seen in at least one of the 
cardinal symptoms of PD (Tremor, Rigidity, or Bradykinesia or other). 
 
Once first therapeutic effect is determined, the site will test for side effects.  The amplitude will continue 
to be increased slowly by the programmer until the first sustainable side effect is observed by the 
blinded evaluator.   
Side effects will be documented based on the determination of the blinded evaluator. 
 
The width of the therapeutic window is defined as the electrical current at which a sustained side effect 
appeared minus the electrical current at which a meaningful therapeutic benefit was obtained.  
 
Subjects are to be programmed and remain programmed in an omnidirectional configuration from the 
initial programming visit until the 3-month visit.  If in the investigator’s opinion, omnidirectional 

 
Study Document No: SJM-CIP-10061 Ver. G 
Study Name: PROGRESS 
Clinical Investigational Plan 
 
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configuration does not provide adequate therapy for the subject, the investigator may change the 
programming to allow the use of a directional configuration. 
 
3-Month Visit - Device testing is to be completed with the subject in the Off Medication state.   
In order minimize bias and maintain the blind as much as possible for the blinded evaluator, the site’s 
designated programmer will be asked to flip a coin to determine which testing configuration will be 
completed first ( “heads” will be designated as omnidirectional and “tails” will be designated 
directional).  This is so that the testing is not always completed in the same order. 
 
Omnidirectional testing will be repeated according to the instructions above.   
 
A detailed directional lead/contact testing will also occur as tolerated by the subject.  The testing will be 
completed in 2 steps for a total of 6 assessments.  Each programming/detailed device testing can be 
performed over multiple days (within the same calendar week).  Each lead will be assessed for first 
meaningful therapeutic effect followed by assessment of first sustainable side effects by the blinded 
evaluator. 
 
Directional Testing: 
Step 1:  8 Channel Lead – Directional assessment of each individual segment of the contact (2 or 3) 
that has been selected as providing the best clinical benefit.  Testing will be completed in the following 
configurations: 
• 
Segment 2 or 3A; followed by; 
• 
Segment 2 or 3B; followed by; 
• 
Segment 2 or 3C. 
 
Step 2 (optional):  8-Channel Lead - Directional testing of 2 segments on the same contact.  Two 
segments may be activated together:  Each of the following configurations may be tested for a total of 3 
separate tests.  Select contact 2 or contact 3 for testing based on the best clinical benefit from testing in 
Step 1: 
• 
A and B activated; followed by; 
• 
B and C activated; followed by;  
• 
A and C activated. 
 
For each of the above steps, the amplitude will be increased slowly by the programmer until the blinded 
evaluator confirms first therapeutic effect.  As the amplitude is increased, the first therapeutic effect on 
the motor symptoms will be based on the blinded evaluator’s clinical judgement.. 
First meaningful therapeutic effect will be determined by the blinded evaluator’s clinical judgement of 
the benefit seen for the subjects primary motor symptoms (i.e.; first benefit seen in at least one of the 
cardinal symptoms of PD (Tremor, Rigidity, or Bradykinesia or other)).  Once first therapeutic effect is 
determined, the site will test for side effects.  The amplitude will continue to be increased slowly by the 
programmer until the first sustainable side effect is observed by the blinded evaluator.  Side effects will 
be documented based on the determination of the blinded evaluator.  
 
Clinicians should use clinical judgement to determine the amount of time required to rest between each 
lead segment evaluation.  It is suggested to allow a minimum of at least a 2-minute rest period between 
each contact/segment testing.  During the testing session the clinician will also rate the subject’s fatigue 
level. 
 

 
Study Document No: SJM-CIP-10061 Ver. G 
Study Name: PROGRESS 
Clinical Investigational Plan 
 
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The width of the therapeutic window is defined as the electrical current at which a sustained side effect 
appeared minus the electrical current at which a meaningful therapeutic benefit was obtained. 
 
At the conclusion of the 3-month visit, the site physician should select the directional program that 
provides the best clinical benefit for the subject based on the detailed device testing that was 
completed and the subject should remain programmed using a directional configuration until the 6-
month visit.  If in the investigator’s opinion, the directional configuration does not provide adequate 
therapy for the subject, the investigator may change the programming to allow the use of an 
omnidirectional configuration.  Subjects who are implanted with the 4 channel lead will only have the 
omnidirectional testing at the initial programming visit to determine therapeutic window and first side 
effect.  At the 3-month visit these subjects will complete the omnidirectional testing, will have the 
programming parameters collected and will complete the visit evaluations. 
 
12-Month Visit - Device testing is to be completed with the subject in the Off Medication state.   
Omnidirectional and directional testing will be repeated according to the instructions above. 
 
36-Month Visit - Device testing is to be completed with the subject in the Off Medication state.   
Omnidirectional and directional testing will be repeated according to the instructions above. 
 
6.7 
UNSCHEDULED VISITS 
An unscheduled visit is defined as any visit that occurs outside of a specified study visit. Only 
unscheduled visits occurring after the permanent implant (all components implanted) will be recorded. 
 
The visit still needs to be documented by completing the appropriate forms if applicable, Adverse 
Event, Death and/or Withdrawal. 
 
6.8 
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 implantation and programming 
 
Sponsor personnel will not:  
• 
Perform the informed consent process  
• 
Practice medicine  
• 
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  
• 
Assist the physician in the completion of the UPDRS or subject in the SUS forms completion 
 
6.9 
SUBJECT STUDY COMPLETION 
When a subject completes the 36-month follow-up visit, the subject’s participation in the clinical study is 
complete. The subject will return to the medical care as per physician’s recommendation. 
 

 
Study Document No: SJM-CIP-10061 Ver. G 
Study Name: PROGRESS 
Clinical Investigational Plan 
 
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6.10 
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 the 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. 
 
6.11 
DESCRIPTION OF THE METHODS THAT WILL BE USED TO ADDRESS POTENTIALLY 
CONFOUNDING FACTORS IN THE CLINICAL STUDY DESIGN (e.g. stratified randomization, 
statistical analysis, etc.) 
Stratified analysis will be used to diagnose potential confounding factors, and multivariable regression 
will be used to adjust the outcome of the primary endpoint in case confounding factors are identified. 
 
Subject factors including, but are not limited to:   
• 
Subject baseline characteristics 
• 
Concomitant medication 
• 
Use of other medical device 
 
6.12 
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. 
 
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 undergoes a system revision or system explant 
 
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). 

 
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Clinical Investigational Plan 
 
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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 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. 
 
If a subject withdraws from the investigation due to problems related to the safety or performance of the 
device under investigation, the investigator shall ask for the subject's permission to follow his/her 
status/condition outside of the clinical investigation as appropriate.  
The status of the subject’s condition should be documented at the time of withdrawal.   
 
 COMPLIANCE TO CIP 
7.1 
STATEMENTS OF COMPLIANCE 
The investigator will not start enrolling subjects or requesting informed consent from any subject prior 
to obtaining EC or IRB approval and Competent Authority approval, if applicable, and authorization 
from the sponsor in writing for the study. 
 
In case additional requirements are imposed by the EC or IRB or Competent Authority, those 
requirements will be followed, if appropriate. If any action is taken by an EC or IRB, and regulatory 
requirements with respect to the study, that information will be forwarded to St. Jude Medical. 
 
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, EC or 
IRB 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. 
 

 
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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 EC or IRB before 
initiating changes in or deviations from the protocol, except when necessary to protect the life or 
physical well-being of a subject in an emergency.  Under emergency circumstances, deviations from 
the CIP to protect the rights, safety and well-being of human subjects may proceed without prior 
approval of the sponsor and the EC or IRB. Such deviations shall be documented and reported to the 
sponsor and the EC or IRB 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). 
 
Investigator will notify St. Jude Medical and the reviewing EC or IRB within 5 working days of: 
• 
Any deviation to protect the life or physical well-being of a subject in an emergency  
• 
Any failure to obtain informed consent 
 
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 EC or 
IRB. 
 
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 

 
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 
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 
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 medical 
device under study. 
 
This definition includes events related to the medical device and the procedures involved. 
 
8.1.2 
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. 
 
8.1.3 
Adverse Device Effect (ADE) 
An adverse event related to the use of a medical device used in the study. 
 
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 medical 
device. 
 
8.1.4 
Serious Adverse Device Effect (SADE) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse 
event. 

 
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8.2 
PROCEDURE FOR ASSESSING, RECORDING, AND REPORTING ADVERSE EVENTS, 
DEVICE DEFICIENCIES/COMPLAINTS, ADVERSE DEVICE EFFECTS, SERIOUS ADVERSE 
EVENTS, AND SERIOUS ADVERSE DEVICE EFFECTS:  
General AE Reporting 
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). Safety 
surveillance and the safety reporting will continue until the last study 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. 
 
Unchanged, chronic, non-worsening or pre-existing conditions are not AEs and should not be reported.  
An offline form will be made available to allow the investigator to report SAEs in the event the entry 
cannot be made in the EDC. This does not replace the EDC reporting system. All information must still 
be entered in the EDC system as soon as feasible. 
 
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. All adverse events will be 
monitored until they are adequately resolved.  The status of the subject’s condition should be 
documented at each visit.   
 
SAE Reporting 
The investigator should report all SAEs to the Sponsor as soon as possible but no later than outlined 
below.  
Clinical Site 
Reporting timelines 
All Sites 
SAEs must be reported to the Sponsor no later than 3 calendar days from the 
day the site personnel became aware of the event or as per the investigative 
site’s local requirements, if the requirement is more stringent than those outlined. 
The date the site staff became aware the event met the criteria of an SAE must be recorded in the 
source document.  The Investigator will further report the SAE to the local IRB/EC according to the 
institution’s IRB/EC reporting requirements. 
 
Reportable events to sponsor are considered: 
1)  All Serious Adverse Events; 
2)  All device related Adverse Events (whether or not the event is considered serious).  
 
Procedure related AEs as noted in Section 3.3 that are not identified as Serious Adverse Events should 
only be reported if they become severe, become reportable as an SAE, or if they continue for greater 
than 30 days after the surgery date.  The following commonly reported procedure related AEs should 
only be reported as AEs if they continue for longer than 30 days postoperatively:   
• 
Headache 
• 
Persistent pain at surgery site or IPG site 
• 
Post-operative pain, stress, or discomfort 

 
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• 
Confusion (transient, nocturnal, or ongoing) 
• 
Cognitive impairment including delirium, dementia, disorientation, psychosis and speech 
difficulties 
• 
Complications from anesthesia 
 
 
The Sponsor will ensure that all events (noted above) 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 EC or IRB, if appropriate, in accordance with national and local laws 
and regulations, of the AEs reported to the Sponsor. 
 
All adverse events (as noted above) will be reported as per applicable regulatory requirements.  
 
In addition to the adverse events commonly associated with surgery, the potential adverse events in 
section 3.3 are associated with a DBS system. 
 
8.3 
SUBJECT DEATH 
8.3.1 
Procedure for recording and reporting subject death 
Should death occur, the investigator is requested to record death information in the hospital records 
and immediately document the information on the AE case report form and submit to Sponsor. The 
death events must be reported as per the SAE reporting requirements provided in the above section 
8.2. All efforts to obtain the details about the circumstances surrounding the patient death should be 
made by the Investigator. The subject’s death, is an outcome of an AE and an early conclusion of the 
subject’s participation in the clinical investigation. Therefore, the Investigator is required to complete the 
Withdrawal form. 
 
8.4 
DEVICE DEFICIENCY (DD)/COMPLAINT REPORTING 
During the study, the Investigator will be responsible for reporting all complaints. A complaint is defined 
as any written, electronic or oral communication that alleges deficiencies related to the identity, quality, 
durability, reliability, safety, effectiveness or performance of a device after it is released for distribution. 
 
If the complaint does not involve an AE, the Investigator must notify the Abbott Post Market 
Surveillance Department by submitting the information on the device via email to  
CCoordinators@sjm.com or by phone at +1 972-309-8000 as soon as possible after becoming aware 
of the complaint. This information will not be collected on a CRF for the study. 
 
If the complaint involves an AE, the Investigator must complete an AE CRF, including the information 
on the complaint and submit to Abbott as soon as possible and in accordance with the local laws and 
regulations.  
 

 
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 DATA MANAGEMENT 
The Sponsor and its affiliates will be responsible for the data handling, and 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 collected or maintained for 
this clinical study.  The privacy of each subject and confidentiality of his/her information will be 
preserved in reports when publishing any data.  Confidentiality of data will be observed by all parties 
involved at all times throughout the clinical study.  All data will be secured against unauthorized access. 
 
The Principal Investigator or institution will provide direct access to source data during and after the 
clinical study for monitoring, audits, EC or IRB review and regulatory authority inspections.  As required, 
the Principal Investigator or institution will obtain permission for direct access to source documents from 
the subject, hospital administration and national regulatory authorities before starting the clinical study. 
 
9.1 
DATA MANAGEMENT PLAN 
A detailed Data Management Plan will be established to ensure consistency of the data. This document 
will include procedures used for data review, database cleaning, and issuing and resolving data 
queries. If appropriate, the DMP may be updated throughout the study duration. All revisions will be 
tracked and document controlled. 
 
CRF data will be captured in a validated electronic database management system hosted by St. Jude 
Medical.  
 
Only authorized site personnel will be permitted to enter the CRF data through the electronic data 
capture (EDC) system deployed by St. Jude Medical. An electronic audit trail will be used to track any 
subsequent changes of the entered data. 
 
9.2 
DOCUMENT AND DATA CONTROL 
9.2.1 
Traceability of documents and data 
The investigator will ensure accuracy, completeness, legibility and timeliness of the data reported to the 
sponsor on the electronic case report forms (eCRFs) 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 eCRFs will be derived from, and be consistent with, these source documents, 
and any discrepancies will be explained in writing. 
 
The CRFs will be signed and validated (eCRF) by the authorized site personnel.  
 

 
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9.2.3 
Protection of Personally Identifiable Information 
The Sponsor respects and protects personally identifiable information collected or maintained for this 
clinical investigation.  
 
The Sponsor implements technical and physical access controls to ensure that Personal Information is 
accessible only to and processed only on a ‘need to know’ basis, including periodic review of access 
rights, and revocation of access when an individual’s employment is terminated or the individual 
transitions to a role that does not require access to Personal Information, and appropriate restrictions 
on physical access to premises, facilities, equipment, and records containing Personal Information. 
 
The Sponsor requires the investigational sites to transfer into Sponsor’s data management systems 
only pseudonymous Personal Information (key-coded) necessary to conduct the Clinical Investigation, 
such as the patient’s medical condition, treatment, dates of treatment, etc. The Sponsor discloses as 
part of the clinical investigation informed consent process that some Sponsor representatives still may 
see Personal Information at the participating sites for technical support of the participating physicians 
on the device implant or procedures, monitoring and quality control purposes. Confidentiality of 
Personal Information will be observed by all parties involved at all times throughout the clinical 
investigation. The privacy of each subject and confidentiality of his/her information will be preserved in 
reports and when publishing any data. 
 
The Sponsor data management systems and processes were designed, developed, and tested 
according to industry standards to appropriately safeguard Confidential Information (including any 
Personal Information) against unauthorized access and/or interference by third parties, intrusion, theft, 
destruction, loss or alteration. Clinical Investigation data are encrypted in transit and at rest.  
 
The Sponsor maintains a Privacy Incident procedure that complies in all respects with Applicable Law 
and industry best practices. 
 
 MONITORING  
It is the responsibility of St. Jude Medical as the sponsor of the study to ensure the study is conducted, 
recorded, and reported according to the approved protocol, subsequent amendment(s), applicable 
regulations, and guidance documents. Monitoring will be conducted according to the St. Jude Medical 
Clinical Monitoring standard operating procedure. 
Prior to beginning the study, St. Jude Medical will contact the investigator or designee to discuss the 
study and data requirements. A St. Jude Medical monitor will periodically review the subject records 
and associated source documents.  
The investigator shall make subject and study records available to the clinical monitor for monitoring.  
 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 

 
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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 EC or IRB have not been submitted or are incomplete, inaccurate, false or misleading. 
 
 
STATISTICAL CONSIDERATIONS 
12.1 
STATISTICAL DESIGN, HYPOTHESES, METHOD AND ANALYTICAL PROCEDURES 
A subset of subjects enrolled in this study will be used to meet the Post Market Clinical Follow-Up 
(PMCF) requirement for CE mark. Once this subset of subjects is enrolled and followed for 12 months 
and have evaluable endpoint data at the 3-month follow-up visit, a report pertaining to primary endpoint 
and secondary endpoints analyses will be submitted indicating completion of this requirement. 
 
12.1.1 Primary Endpoint 
The proportion of subjects with a therapeutic window (evaluated by a blinded evaluator) which is larger 
under directional stimulation than omnidirectional stimulation will be tested against a performance goal 
of 60% at the 3-month follow-up visit.  
 
The width of the therapeutic window is defined as the electrical current at which a sustained side effect 
appeared minus the electrical current at which a meaningful therapeutic benefit was obtained.  The 
directional segment with the widest therapeutic window will be compared to omnidirectional stimulation. 
 
Hypothesis 
 
The hypothesis is formally expressed as:  
 
H0: p ≤ 0.60  
 
Ha: p > 0.60 
 
where p is the probability that the therapeutic window under directional stimulation is larger than the 
therapeutic window under omnidirectional stimulation. 
 
Analysis 
  
The primary endpoint will be tested at the 5% significance level.  The analysis population includes 
subjects who have evaluable therapeutic window using omnidirectional and directional stimulation. The 
analysis will be carried out by calculating the 95% lower confidence bound (LCB) on the success rate 
using the Clopper-Pearson exact method. The null hypothesis will be rejected if the 95% lower 
confidence bound (LCB) for p is greater than 0.60.   
 

 
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12.1.2 Secondary Endpoint 
12.1.2.1 
Secondary Endpoint 1 
If the primary study endpoint is not met, the following hypothesis will be tested to evaluate non-
inferiority of therapeutic window with directional stimulation compared to omnidirectional stimulation. 
 
 
Hypothesis 
 
The hypothesis is formally expressed as:  
 
H0: p ≤ 0.40  
 
Ha: p > 0.40 
 
where p is the probability that the therapeutic window under directional stimulation is larger than the 
therapeutic window under omnidirectional stimulation (success). 
 
Analysis 
  
The secondary endpoint will be tested at the 5% significance level.  The analysis population includes 
subjects who have evaluable therapeutic windows under omnidirectional and directional stimulation. 
The analysis will be carried out by calculating the 95% lower confidence bound (LCB) on the success 
rate using the Clopper-Pearson exact method. The null hypothesis will be rejected if the 95% lower 
confidence bound (LCB) for p is greater than 0.40.   
 
12.1.2.2 
Secondary Endpoint 2 
The endpoint will test whether directional stimulation has greater therapeutic effect than omnidirectional 
stimulation by comparison of 3- and 6-month UPDRS part III motor examination (as evaluated by a 
blinded evaluator). 
 
Change in UPDRS part III motor examination within each subject is defined as:  
 
Change in UPDRS part III = UPDRS part III at 3 month (omnidirectional) – UPDRS part III at 6 months 
(directional) 
 
The following hypothesis will be tested: 
 
H0: mean change in UPDRS part III motor examination ≤ 0   
 
Ha: mean change in UPDRS part III motor examination > 0 
 
Analysis 
  
The hypothesis will be tested at the 5% significance level.  The analysis will be carried out by 
calculating the 95% lower confidence bound (LCB) on the mean change in UPDRS part III motor 
examination score based on a t-distribution. The null hypothesis will be rejected if the 95% LCB is 
greater than 0. 

 
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12.2 
SAMPLE SIZE 
The sample size is calculated assuming a success (therapeutic window of directional stimulation is 
larger than the one of omnidirectional stimulation) rate of 75%.  A sample size of 62 subjects will 
provide 80% power to reject the null hypothesis at a 5% significance level. Accounting for attrition of 
5%, a total sample size of 66 completed subjects will be required. The sample size was computed 
using SAS version 9.3. Enrollment will continue after meeting the PMCF requirement, with total 
enrollment of up to 350 subjects. 
 
12.3 
PASS/FAIL CRITERIA TO BE APPLIED TO THE RESULTS OF THE CLINICAL STUDY 
There are no pass/fail criteria to be applied to the results of this clinical study. 
 
12.4 
THE PROVISION FOR AN INTERIM ANALYSIS, when applicable 
Masked interim analysis will be performed to compare distribution of therapeutic window at 3 months, 
and to compare UPDRS at 3 and 6 months. Group names will be masked. Masked analysis will also be 
performed for the subset of subjects enrolled at implant, and for the subset of subjects enrolled after 
implant. Additional unblinded interim analysis will be conducted after additional subjects reach 3 
months of follow-up. 
 
12.5 
CRITERIA FOR THE TERMINATION OF THE CLINICAL STUDY ON STATISTICAL GROUNDS 
There is no planned termination for the study based on statistical grounds. 
 
12.6 
PROCEDURES FOR REPORTING ANY DEVIATION(S) FROM THE ORIGINAL STATISTICAL 
PLAN 
Any deviations from the statistical analysis plan will be documented. 
 
12.7 
THE SPECIFICATION OF SUBGROUPS FOR ANALYSIS 
There will be a subgroup analysis of change in UPDRS part III motor examination score from 3 months 
to 6 months for the subset of subjects using omnidirectional stimulation at 3 months and directional 
stimulation at 6 months. Subject and clinician preference will be evaluated for the subset who have 
omnidirectional stimulation for the first 3 months and directional stimulation for the subsequent 3 
months. There will also be a subgroup analysis of endpoints for the subset of subjects enrolled at 
implant, and for the subset of subjects enrolled after implant. 
 
12.8 
PROCEDURES THAT TAKE INTO ACCOUNT ALL THE DATA 
Analyses will be performed in subjects who have evaluable therapeutic windows for both 
omnidirectional and directional stimulation for the primary endpoint and the first secondary endpoint. 
The analysis will be performed in subjects who have 3- and 6-month UPDRS part III motor examination 

 
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complete for the second secondary endpoint.  Subject accountability for enrolled subjects will be 
performed prior to analyses of the primary and secondary endpoints.  
 
12.9 
THE TREATMENT OF MISSING, UNUSED, OR SPURIOUS DATA, INCLUDING DROP-OUTS 
AND WITHDRAWALS 
There are no plans to perform imputations for missing data, subject dropouts or withdrawals. If spurious 
data are discovered, these data will be excluded from analyses. Reasons for exclusion of any data from 
analyses will be summarized. 
 
12.10 THE EXCLUSION OF PARTICULAR INFORMATION FOR THE TESTING OF THE 
HYPOTHESIS 
There are no intent to exclude information for the testing of the hypothesis. 
 
12.11 IN MULTI-CENTER STUDIES, THE MINIMUM AND MAXIMUM NUMBER OF SUBJECTS TO 
BE INCLUDED FOR EACH CENTER 
A minimum of 1 subject may be included at each center participating in the study. 
 
12.12 TIMING FOR ANALYSES 
The dataset will be frozen for analysis when 66 subjects have completed the 12-month visit and have 
evaluable primary endpoint at the 3-month follow-up visit to support the minimum requirements to meet 
the Post Market Clinical Follow-Up (PMCF) requirement for CE mark. 
 
DOCUMENT RETENTION 
St. Jude Medical and the Principal Investigators will maintain the clinical study documents as required 
by St. Jude Medical, Inc. and applicable regulatory requirements.  They will take measures to prevent 
accidental or premature destruction of these documents.  The Principal Investigator or St. Jude Medical 
may transfer custody of records to another person/party and document the transfer at the 
investigational site or at St. Jude Medical’s facility. 
 
These documents must be retained by the investigational site for a period of 2 years after clinical study 
conclusion and made available for monitoring or auditing by St. Jude Medical’s representative or 
representatives of the FDA and other applicable regulatory agencies.  The Principal Investigator must 
ensure the availability of source documents from which the information on the case report forms was 
derived. 
 
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 Steering Committee (if applicable). The Steering Committee is responsible for 

 
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overseeing the scientific and operational aspects of the clinical investigation. This committee will meet 
regularly to monitor subject enrollment, general data collection and non-compliance with the CIP at 
individual centers, to review operational issues that may arise and warrant a CIP amendment or other 
corrective action and to determine policy regarding any publications arising from data generated from 
the performance of the clinical investigation. 
 
The amendments to the CIP and the subject’s Informed Consent will be notified to, or approved by, the 
EC or IRB and regulatory authorities, if required. The version number and date of amendments will be 
documented. 
 
The amendment will identify the changes made, the reason for the changes and if it is mandatory or 
optional to implement the amendment. 
 
Any amendment affecting the subject requires that the subject be informed of the changes and a new 
consent be signed and dated by the investigator at the subject’s next follow up. 
 
Changes to, or formal clarifications of, the CIP will be documented in writing and provided to the 
investigators. This information will be incorporated when an amendment occurs. 
 
 
 
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 or Institutional Review Board 
 
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. 

 
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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 EC or IRB and/or 
the Competent Authority (if applicable). Follow-up for all enrolled subjects will be as per CIP 
requirements. 
 
A Principal Investigator, EC or IRB 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 EC or IRB 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 
EC or IRB 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 EC or IRB 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, EC or IRB, 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 EC or IRB or regulatory 
authority where appropriate.   
 
If subjects have been informed of the suspension, the Principal Investigator or authorized designee will 
inform subjects of the reasons for resumption. 

 
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Clinical Investigational Plan 
 
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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. The final report will be submitted within one year 
of the end of the investigation. 
 
 
PUBLICATION POLICY 
The results of the clinical study will be submitted, whether positive or negative for publication.  
 
A ‘Publication Agreement’ will be signed between the Principal Investigator and the Sponsor either as a 
separate Publication Agreement or within the Clinical Trial Agreement. 
 
For more information on publication guidelines, please refer to the International Committee of Medical 
Journal Editors (ICMJE) on www.icmje.org. 
 
This study will be posted on ClinicalTrials.gov and results will be posted on ClinicalTrials.gov as 
required.  
 
 
BIBLIOGRAPHY  
1. Kleiner-Fisman, G., et al. Subthalamic nucleus deep brain stimulation: summary and meta-analysis 
of outcomes. Mov Disord, 2006. 21 Suppl 14: p. S290-304. 
2. Deuschl, G., et al., A randomized trial of deep-brain stimulation for Parkinson's disease. N Engl J 
Med, 2006. 355(9): p. 896-908.  
3. Follett, K.A., et al., Pallidal versus subthalamic deep-brain stimulation for Parkinson's disease. New 
England Journal of Medicine, 2010. 362(22): p. 2077-2091.  
4. Hariz, M.I., et al., Multicentre European study of thalamic stimulation for parkinsonian tremor: a 6 
year follow-up. J Neurol Neurosurg Psychiatry, 2008. 79(6): p. 694-9.  
5. Okun, M.S., Deep-brain stimulation for Parkinson's disease. New England Journal of Medicine, 
2012. 367(16): p. 1529-1538.  
6. Schwalb, J.M. and C. Hamani, The history and future of deep brain stimulation. Neurotherapeutics, 
2008. 5(1): p. 3-13.  
7. Keane, M., et al., Improved spatial targeting with directionally segmented deep brain stimulation 
leads for treating essential tremor. J Neural Eng, 2012. 9(4): p. 046005.  
8. Butson, C.R. and C.C. McIntyre, Current steering to control the volume of tissue activated during 
deep brain stimulation. Brain Stimul, 2008. 1(1): p. 7-15.  
9. Maks, C.B., et al., Deep brain stimulation activation volumes and their association with 
neurophysiological mapping and therapeutic outcomes. J Neurol Neurosurg Psychiatry, 2009. 
80(6): p. 659-66.  
10. Cheung, T., et al., Defining a therapeutic target for pallidal deep brain stimulation for dystonia. Ann 
Neurol, 2014. 76(1): p. 22-30.  
11. Buhlmann, J., et al., Modeling of a segmented electrode for desynchronizing deep brain stimulation. 
Front Neuroeng, 2011. 4: p. 15.  

 
Study Document No: SJM-CIP-10061 Ver. G 
Study Name: PROGRESS 
Clinical Investigational Plan 
 
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or used without the express written consent of St. Jude Medical 
12. Butson, C.R. and C.C. McIntyre, Role of electrode design on the volume of tissue activated during 
deep brain stimulation. Journal of Neural Engineering, 2006. 3(1): p. 1.  
13. Tripoliti, E., et al., Effects of contact location and voltage amplitude on speech and movement in 
bilateral subthalamic nucleus deep brain stimulation. Mov Disord, 2008. 23(16): p. 2377-83.  
14. Chaturvedi, A., T.J. Foutz, and C.C. McIntyre, Current steering to activate targeted neural pathways 
during deep brain stimulation of the subthalamic region. Brain Stimul, 2012. 5(3): p. 369-77.  
15. Pollo, C., et al., Directional deep brain stimulation: an intraoperative double-blind pilot study. Brain, 
2014. 137(Pt 7): p. 2015-26.  
16. Rodriguez-Oroz, M.C., et al., Bilateral deep brain stimulation in Parkinson's disease: a multicentre 
study with 4 years follow-up. Brain, 2005. 128(Pt 10): p. 2240-9.  
17. Sarem-Aslani, A. and K. Mullett, Industrial perspective on deep brain stimulation: history, current 
state, and future developments. Front Integr Neurosci, 2011. 5: p. 46.  
18. Contarino, M.F., et al., Directional steering: A novel approach to deep brain stimulation. Neurology, 
2014. 83(13): p. 1163-9. 
 

 
Study Document No: SJM-CIP-10061 Ver. G 
Study Name: PROGRESS 
Clinical Investigational Plan 
 
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APPENDIX A: ABBREVIATIONS 
Select or add abbreviations used 
Abbreviation 
Term 
ADE 
AE 
ANZ 
ASADE 
CIP 
CRF 
CT 
DBS 
DD 
DMP 
DSMB 
EC 
eCRF 
EDC 
EMEA 
GP 
IB 
ICMJE 
IRB 
ISO 
MDR 
MRI 
NA 
PI 
PMCF 
PD 
RDC 
SADE 
SAE 
SC  
SJM 
STN 
SUS 
UPDRS 
USADE 
 
Adverse Device Effect 
Adverse Event 
Australia – New Zealand 
Anticipated Serious Adverse Device Effect 
Clinical Investigational Plan 
Case Report Form 
Computed Tomography 
Deep Brain Stimulation 
Device Deficiency 
Data Management Plan 
Data Safety Monitoring Board  
Ethics Committee 
Electronic Case Report Form 
Electronic Data Capture 
Europe, Middle East, Africa 
General Practitioner 
Investigator Brochure 
International Committee of Medical Journal Editors 
Institutional Review Board 
International Organization for Standardization 
Medical Device Reporting 
Magnetic Resonance Imaging 
Not Applicable 
Principal Investigator 
Post Market Clinical Follow Up 
Parkinson’s disease 
Remote Data Capture 
Serious Adverse Device Effect 
Serious Adverse Event 
Steering Committee 
St. Jude Medical 
Subthalamic Nucleus 
System Usability Scale 
Unified Parkinson’s Disease Rating Scale 
Unanticipated Serious Adverse Device Effect 
 
 
 
 
 
 

 
Study Document No: SJM-CIP-10061 Ver. G 
Study Name: PROGRESS 
Clinical Investigational Plan 
 
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APPENDIX B: CIP REVISION HISTORY 
 
Revision History 
Amendment 
Number 
Version Date 
Rationale 
Details 
Not 
Applicable 
A 
26May2016 
First release of CIP 
Not Applicable 
1 
B 
18JUL2016 
Coordinating investigator 
suggested blinding the 
subject and adding a 
blinded evaluator in order 
to decrease potential 
study/programming bias.  
Modified descriptive 
endpoints to clarify that 
results will be compared to 
baseline visit, 
Added that the subject will be 
blinded to programmed settings for 
the first 6 months and added a 
blinded evaluator for the 
therapeutic window evaluation at 
initial and 3 month device testing 
and UPDRS Section III at 3 and 6 
months visits. 
Clarified that results of the 3, 6, and 
12 month visits for PDQ39 and 
UPDRS will be compared to 
baseline visit.  
2 
C 
01AUG2016 Coordinating investigator 
suggested removing the 
words “within the prior 3 
months” from the 2nd 
inclusion criteria so that 
the protocol is less 
restrictive for enrollment of 
subjects who already have 
the device implanted. Also 
added requirement to 
complete omnidirectional 
testing at 3 months and 
added blinded evaluation 
of therapeutic window 
(omni and directional) to 
12 month visit to show 
change over time. 
Removed words “within the prior 3 
months” from the 2nd inclusion 
criteria.  Added omnidirectional 
testing (by blinded evaluator) to 
Month 3 visit and added 
omnidirectional and directional 
testing (evaluated by blinded 
evauator) of therapeutic window to 
Month 12 visit.  Changed Day 0 
from implant date to Initial 
programming date.  
3 
D 
10FEB2017 
The Coordinating 
Investigator and other 
neurologist review of 
protocol recommended 
that it be clarified that the 
therapeutic window 
evaluation/device testing 
and an additional UPDRS 
III should be completed 
Clarified in the Inclusion criteria 
that subjects should be bilaterally 
implanted.  Clarified within the 
therapeutic window/device testing 
section that the testing should be 
completed with the subject in the 
medication off state.  Provided 
guidance on when subjects should 
be considered in the off medication 

 
Study Document No: SJM-CIP-10061 Ver. G 
Study Name: PROGRESS 
Clinical Investigational Plan 
 
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with the subject in the 
medication off state at the 
3 and 12 month visits.  In 
addition we clarified that 
for study inclusion subjects 
should be bilaterally 
implanted. 
state.  Added additional UPDRS III 
(Off medication) evaluation to the 3 
and 12 month visit for comparison 
to baseline Off medication UPDRS 
III. Throughout protocol made 
modifications to consistently 
describe the therapeutic effect and 
provided guidance for 
determination of first therapeutic 
effect. Added the suggestion that 
programming session data be sent 
to the Sponsor as requested from 
data management. 
Not 
Applicable 
E 
Not 
Applicable 
There is no version E of 
this document. Revision 
after Version D will be 
labeled Version F to align 
with document tracking 
system. 
Existing protocol in document 
tracking system was Version E; 
however, Version D was displayed 
on document. 
4 
F 
24OCT2018 
After internal review and 
discussion with Steering 
Committee, minor 
additional changes were 
made to CIP. 
Added provision for masked 
analysis, clarified event reporting 
and made some data points 
optional. 
5 
G 
23NOV2019 Additional follow-up will be 
collected up to 3 years 
post-initial programming. 
Addition of 24- and 36-month 
follow-up visit to the study 
schedule. 
 
 
 

 
Study Document No: SJM-CIP-10061 Ver. G 
Study Name: PROGRESS 
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-10061 Ver. G 
Study Name: PROGRESS 
Clinical Investigational Plan 
 
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Appendix D: INFINITY DBS SYSTEM COMPONENTS 
The Infinity DBS system under investigation includes the following devices and accessories: 
 
Component 
Model Number and Name 
DBS IPG 
6660 Infinity 5 IPG 
6662 Infinity 7 IPG 
Lead 
6170 8-channel directional lead, 30 cm, 0.5 mm spacing 
6171 8-channel directional lead, 30 cm, 1.5 mm spacing 
6172 8-channel directional lead, 40 cm, 0.5 mm spacing 
6173 8-channel directional lead, 40 cm, 1.5 mm spacing 
6166 4-channel lead, 30 cm, 0.5 mm spacing 
6167 4-channel lead, 30 cm, 1.5 mm spacing 
6168 4-channel lead, 40 cm, 0.5 mm spacing 
6169 4-channel lead, 40 cm, 1.5 mm spacing 
Extension 
6371 8-channel flexible extension, 50 cm 
6372 8-channel flexible extension, 60 cm 
6373 8-channel flexible extension, 90 cm 
6355 4-channel flexible extension, 50 cm 
6356 4-channel flexible extension, 60 cm 
6359 4-channel flexible extension, 90 cm 
Accessory 
6010 Guardian™ cranial burr hole cover system 
6015 Screw, 5 mm 
1190 Tunneling tool, 0.125” 
1101 Torque wrench 
1111 Port plug 
Large pocket sizer 
Small pocket sizer 
6599 DBS EPG, 16 channel 
3014 Multi-lead trial cable 
1210 Patient magnet 
1803 Lead and extension insertion tool 
1140 DBS lead stop 
Clinician Programmer 
3874 Clinician programmer application 
Patient Controller 
3875 Patient controller application 
 
 
 
 
 

 
Study Document No: SJM-CIP-10061 Ver. G 
Study Name: PROGRESS 
Clinical Investigational Plan 
 
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Appendix E: 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.  
 
Appendix F: SAMPLE INFORMED CONSENT 
The study specific informed consent template will be kept under a separate cover and is available upon 
request.  
 
 
Appendix G: CASE REPORT FORMS 
Final Case Report Forms will be kept under a separate cover and are available upon request.