Prospective Evaluation Comparing the Effects of Constant Current Versus Constant Voltage in Deep Brain Stimulation Using Hybrid Systems
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 
Template 
Page 1 of 1 
 
NCT Number: NCT02963259 
PREFERENCE-H 
Prospective Evaluation comparing the Effects of Constant Current versus Constant Voltage in Deep 
Brain Stimulation using Hybrid systems 
Study Document No: SJM-CIP-10125 
Version B 
Date: 10-OCT-2016 
 
 
Sponsor  
 
 
Abbott/ SJM International, Inc.  
        
 
 
 
The Corporate Village 
Da Vincilaan 11-box F1 
      
  
 
 
B-1935 Zaventem 
        
 
 
 
Belgium 
 
 
 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
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Reference:  
SJM-CIP-10135 
 
PREFERENCE-H 
 Prospective Evaluation comparing the Effects of Constant Current versus Constant 
Voltage in Deep Brain Stimulation using hybrid systems. 
Clinical Investigation Plan (CIP) 
 
Sponsor  
 
 
 
St. Jude Medical International, Inc. 
The Corporate Village 
Da Vincilaan 11-box F1 
B-1935 Zaventem 
Belgium 
 
 
Clinical Coordinating   
Investigator                             Az.Osp. Universitaria di Ferrara  
 
 
 
 
 
via Aldo Moro, 8  
 
 
 
 
 
Cona, Emilia-Romagna 
 
 
 
 
 
44124 
 
 
 
 
 
Italy 
 
 
 
 
 
 
 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
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PRINICPAL INVESTIGATOR SIGNATURE PAGE 
PREFERENCE-H 
 
Reference #: SJM-CIP-10135 
Version A 
 
 
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-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 3 of 41 
 
 
 
Coordinating Investigator 
 
SIGNATURE PAGE 
 
 
PREFERENCE-H 
Reference #: SJM-CIP-10135 
Version A 
 
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:  ____________________ 
 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
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Table of Contents 
Page 
 
Synopsis ........................................................................................................................................ 6 
1.0
1.1 STUDY FLOW CHART ...................................................................................................................................... 9 
1.2 STUDY CONTACTS .......................................................................................................................................... 9 
 
Background and Justification for Clinical Study ............................................................................ 10 
2.0
 
Risks and Benefits of the Clinical Study ....................................................................................... 11 
3.0
3.1 DESCRIPTION OF SUBJECT POPULATION ................................................................................................ 11 
3.2 ANTICIPATED CLINICAL BENEFITS .......................................................................................................... 11 
3.3 ANTICIPATED ADVERSE EVENTS AND ADVERSE DEVICE EFFECTS ................................................ 11 
3.4 RESIDUAL RISKS ASSOCIATED WITH THE DEVICE UNDER INVESTIGATION, AS IDENTIFIED IN 
THE RISK ANALYSIS REPORT .............................................................................................................................. 12 
3.5 RISKS ASSOCIATED WITH PARTICIPATION IN THE CLINICAL STUDY ............................................. 13 
3.6 POSSIBLE INTERACTIONS WITH CONCOMITANT MEDICAL TREATMENTS AND/OR CONCURRENT 
MEDICAL INTERVENTIONS .................................................................................................................................. 13 
3.7 STEPS THAT WILL BE TAKEN TO CONTROL OR MITIGATE THE RISKS ........................................... 13 
3.8 RISK-TO-BENEFIT RATIONALE ................................................................................................................... 13 
3.9 DESCRIPTION OF HISTORY OF MODIFICATIONS OR RECALL IN RELATION TO SAFETY AND 
CLINICAL PERFORMANCE FOR DEVICE UNDER INVESTIGATION ............................................................. 13 
 
Study Design ............................................................................................................................... 13 
4.0
4.1 PURPOSE .......................................................................................................................................................... 13 
4.2 STUDY DESIGN AND SCOPE ........................................................................................................................ 13 
4.3 OBJECTIVES .................................................................................................................................................... 14 
4.4 ENDPOINTS...................................................................................................................................................... 14 
4.5 INCLUSION AND EXCLUSION CRITERIA .................................................................................................. 15 
4.6 SUBJECT POPULATION ................................................................................................................................. 16 
4.7 INFORMED CONSENT PROCESS ................................................................................................................. 16 
 
Device under Investigation and Control/Comparators .................................................................. 17 
5.0
5.1 DEVICE DESCRIPTION .................................................................................................................................. 17 
5.2 DEVICE HANDLING AND STORAGE .......................................................................................................... 17 
 
Procedures .................................................................................................................................. 18 
6.0
6.1 STUDY FLOW CHART .................................................................................................................................... 18 
6.2 PROCEDURES .................................................................................................................................................. 18 
6.3 ENROLLMENT VISIT...................................................................................................................................... 21 
6.4 BASELINE VISIT ............................................................................................................................................. 22 
6.5 IPG REPLACEMENT VISIT & PROGRAMMING ......................................................................................... 23 
6.6 3 MONTH FOLLOW UP VISIT (3 months +/- 30 days after IPG replacement) .............................................. 23 
6.7 12 MONTH FOLLOW UP VISIT (12 months +/- 30 days after IPG replacement) .......................................... 23 
6.8 UNSCHEDULED VISIT ................................................................................................................................... 24 
6.9 DESCRIPTION OF ACTIVITIES PERFORMED BY SPONSOR REPRESENTATIVES ............................. 24 
6.10 SUBJECT STUDY COMPLETION .................................................................................................................. 25 
6.11 ANY KNOWN OR FORSEEABLE FACTORS THAT MAY COMPROMISE THE OUTCOME OF THE 
CLINICAL STUDY OR THE INTERPRETATION OF THE RESULTS................................................................. 25 
6.12 CRITERIA AND PROCEDURES FOR SUBJECT WITHDRAWAL OR DISCONTINUATION .................. 25 
 
Compliance to CIP ....................................................................................................................... 26 
7.0
7.1 STATEMENTS OF COMPLIANCE ................................................................................................................. 26 
7.2 ADHERENCE TO THE CLINICAL INVESTIGATION PLAN ...................................................................... 26 
7.3 REPEATED AND SERIOUS NON-COMPLIANCE ....................................................................................... 27 
 
Adverse Events ........................................................................................................................... 27 
8.0

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
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8.1 DEFINITIONS ................................................................................................................................................... 27 
8.2 PROCEDURE FOR ASSESSING, RECORDING, AND REPORTING ADVERSE EVENTS, DEVICE 
DEFICIENCIES/COMPLAINTS, ADVERSE DEVICE EFFECTS, SERIOUS ADVERSE EVENTS, AND SERIOUS 
ADVERSE DEVICE EFFECTS: ................................................................................................................................ 29 
8.3 SUBJECT DEATH ............................................................................................................................................ 30 
8.4 DEVICE DEFICIENCY (DD) / COMPLAINTS ............................................................................................... 30 
 
Data Management ....................................................................................................................... 30 
9.0
9.1 DATA MANAGEMENT PLAN ........................................................................................................................ 31 
9.2 DOCUMENT AND DATA CONTROL ............................................................................................................ 31 
 Monitoring .................................................................................................................................... 31 
10.0
 Regulatory Inspections ................................................................................................................ 32 
11.0
 Statistical considerations ............................................................................................................. 32 
12.0
12.1 STATISTICAL DESIGN, HYPOTHESES, METHOD AND ANALYTICAL PROCEDURES ...................... 32 
12.2 SAMPLE SIZE................................................................................................................................................... 33 
12.3 PROCEDURES FOR REPORTING ANY DEVIATION(S) FROM THE ORIGINAL STATISTICAL PLAN33 
12.4 THE SPECIFICATION OF SUBGROUPS FOR ANALYSIS .......................................................................... 33 
12.5 PROCEDURES THAT TAKE INTO ACCOUNT ALL THE DATA ............................................................... 33 
12.6 THE TREATMENT OF MISSING, UNUSED, OR SPURIOUS DATA, INCLUDING DROP-OUTS AND 
WITHDRAWALS ...................................................................................................................................................... 34 
12.7 THE EXCLUSION OF PARTICULAR INFORMATION FOR THE TESTING OF THE HYPOTHESIS, if 
relevant ....................................................................................................................................................................... 34 
12.8 IN MULTI-CENTER STUDIES, THE MINIMUM AND MAXIMUM NUMBER OF SUBJECTS TO BE 
INCLUDED FOR EACH CENTER ........................................................................................................................... 34 
 Document Retention .................................................................................................................... 34 
13.0
 Amendments to Clinical Investigational Plan ............................................................................... 34 
14.0
 Investigation Suspension or Termination ..................................................................................... 35 
15.0
15.1 PREMATURE TERMINATION OF THE WHOLE CLINICAL STUDY OR OF THE CLINICAL STUDY IN 
ONE OR MORE INVESTIGATIONAL SITES......................................................................................................... 35 
15.2 RESUMING THE STUDY AFTER TEMPORARY SUSPENSION ................................................................ 36 
15.3 STUDY CONCLUSION .................................................................................................................................... 36 
 Publication Policy ........................................................................................................................ 36 
16.0
 Bibliography ................................................................................................................................. 37 
17.0
Appendix A: ABBREVIATIONS ............................................................................................................ 39 
Appendix B: CIP REVISION HISTORY ................................................................................................ 40 
Appendix C: DECLARATION OF HELSINKI......................................................................................... 41 
Appendix D: DEVICE MANUAL ............................................................................................................ 41 
Appendix E: LIST OF CLINICAL INVESTIGATION SITES AND IRB/EC .............................................. 41 
Appendix F: SAMPLE INFORMED CONSENT ..................................................................................... 41 
Appendix G: CASE REPORT FORMS ................................................................................................. 41 
 
 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
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 SYNOPSIS  
1.0
 
Title: 
Prospective evaluation comparing the effects of constant current versus 
constant voltage in Deep Brain Stimulation using hybrid systems*. 
Acronym: 
PREFERENCE-H 
Purpose: 
To evaluate subject’s preference for different stimulation modes (i.e. 
constant voltage and constant current).  
Primary Objective: 
The primary objective of the study is to demonstrate the subject’s 
preference for a stimulation modality. 
Secondary Objective: 
The secondary objective of the study is to demonstrate the safety of the 
hybrid DBS system. 
Primary Endpoint: 
The primary endpoint is the proportion of subjects who indicate 
preference on constant current over constant voltage at the 3 Month 
follow-up visit. 
Secondary Endpoint: 
The secondary endpoint is the rate of safety events related to battery 
replacement procedures for hybrid systems. 
Descriptive 
Endpoints:  
 
The change in Speech Handicap Index at 3 and 12 Months 
compared to Baseline; 
 
The change in total UPDRS score and the individual UPDRS 
components at 3 and 12 Months compared to Baseline;  
 
The change in Levodopa medication at 3 and 12 Months 
compared to Baseline;   
 
The change in Freezing of Gait Questionnaire (FOGQ) scores at 
3 and 12 Months compared to Baseline; 
 
The change in Tinetti Test scores at 3 and 12 Months compared 
to Baseline; 
 
The change in Berg Balance Scale scores at 3 and 12 Months 
compared to Baseline;  
 
The change in PDQ-39 scores at 3 and 12 Months compared to 
Baseline; 
 
Proportion of subjects who indicate satisfaction with constant 
current at 3 and 12 Months;  
 
Proportion of caregivers who indicate satisfaction with constant 
current at 3 and12 Months; 
 
Proportion of subjects who indicate preference on the constant 
current over the constant voltage at the 12 Month follow-up visit; 
 
Summary of Health Economic Data for constant current 
compared to constant voltage. 
 
Design: 
Prospective, multicenter, multinational, post-market clinical study. 
 
The clinical study will be conducted in approximately 20 centers in 
Europe, Australia and the United States and approx. 170 subjects will be 
enrolled. 
Subjects will be followed for 12 months post battery replacement.   
The total duration of the study for a subject is expected to be 
approximately 15-24 months.  

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
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Devices used: 
 
St Jude Medical InfinityTM DBS system 
 
St Jude Medical BrioTM DBS system 
Study Population 
Subjects who have a diagnosis matching the approved indication and are 
being considered for an IPG replacement comprise the target population 
of this study. All subjects who meet the inclusion and none of the 
exclusion criteria and have signed an Ethics Committee (EC) or 
Institutional Review Board (IRB) approved informed consent will be 
considered enrolled in the study.  
Inclusion/Exclusion 
Criteria  
Inclusion Criteria: 
Subjects meeting all the inclusion criteria can be considered for inclusion 
in the study: 
• 
Subject signed the approved Informed Consent; 
• 
Subject is ≥18 and ≤ 74 years of age;  
• 
Subject is bilaterally treated with deep brain stimulation (DBS) in the 
subthalamic nucleus (STN) using a constant voltage device (i.e. 
Soletra™, Itrel™, Kinetra™, ActivaPC™ or ActivaRC™ IPG) and in 
the Investigator’s opinion,  is responding satisfactory to CV 
stimulation;  
• 
In the physician’s opinion the subject is a suitable candidate for an 
IPG replacement with different stimulation paradigm;  
• 
Subject needs and/or requests an IPG replacement within 12 months 
after consent and the current IPG has at least 2.6 V output left (i.e. 
approx. 30% of full battery capacity) at the time of subject enrollment;  
• 
PD symptom onset is no longer than 20 years; 
• 
Subject has a Hoehn & Yahr score <IV (on stim); 
• 
Subject with  a normal cognitive  function (MMSE ≥ 25); 
• 
Subject is fluent speaker (as judged by the investigator) of the 
language spoken in the country where the investigational site is 
located.  
 
Exclusion Criteria : 
Subjects will be excluded from the study if they meet any of the following 
criteria: 
• 
IPG battery has less than 30% battery life at the time of consent;  
• 
Need to replace or reposition the leads or extensions during the IPG 
replacement procedure; 
• 
Subject had >10 recurrent falls experienced in the 3 months prior to 
consent;    
• 
Subject is unwilling to change to either a St Jude Medical InfinityTM or 
a St Jude Medical BrioTM DBS system for the IPG replacement; 
• 
Subject is unable to attend the study visits. 
Data Collection 
Data will be collected at Enrollment, Baseline, IPG replacement, 3 
Months and 12 Months after IPG replacement. 
 
At the Enrollment Visit the Informed Consent procedure will be 
completed, Inclusion and Exclusion Criteria confirmed, Demographic and 
Medical History data collected.  
 
At the Baseline Visit the following will be collected: Stimulation 

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Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
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Programming Settings, Medication, Health Economic Data, Speech 
Handicap Index, Freezing of Gait Questionnaire, Tinetti Test, Berg 
Balance Scale, Parkinson’s Disease Questionnaire, Unified Parkinson’s 
Disease Rating Scale (Part I, II IV On Med/OnStim, Part III On Med/On 
Stim and On Med/Off Stim), Satisfaction of Therapy Questionnaire for the 
subject and the caregiver, Adverse Events or Withdrawal (if applicable) 
 
 
At the IPG Replacement Visit the implanted Medtronic® IPG will be 
explanted and replaced by a SJM Infinity™ DBS IPG or a SJM BrioTM 
DBS system according to the standard surgical procedures and 
instructions for use. The time point for the replacement will be decided by 
the physician according to their standard procedure. Intra-operative 
assessments and the initial CC programming session will be performed 
according to each individual site’s standard procedure. The frequency, 
pulse width and number of contacts (monopolar/bipolar) of the 
stimulation should be kept constant between the constant voltage and 
the constant current stimulation. The following data will be collected: 
Implant Information, Initial Programming Information, Adverse Events or 
Withdrawal (if applicable) 
 
At the 3 Months Visit the following will be collected: Stimulation 
Programming Settings, Medication, Speech Handicap Index, Freezing of 
Gait Questionnaire, Tinetti Test, Berg Balance Scale, Parkinson’s 
Disease Questionnaire, Unified Parkinson’s Disease Rating Scale (Part I, 
II, IV On Med/OnStim, Part III On Med/On Stim and On Med/Off Stim), 
Satisfaction of Therapy Questionnaire for the subject and the caregiver, 
Subject’s Preference, Adverse Events or Withdrawal (if applicable) 
 
At the 12 Months Visit the following will be collected: Stimulation 
Programming Settings, Medication, Speech Handicap Index, Freezing of 
Gait Questionnaire, Tinetti Test, Berg Balance Scale, Parkinson’s 
Disease Questionnaire, Unified Parkinson’s Disease Rating Scale (Part I, 
II, IV On Med/OnStim,  Part III On Med/On Stim and On Med/Off Stim), 
Satisfaction of Therapy Questionnaire for the subject and the caregiver, 
Health Economic Data, Subject’s Preference, Adverse Events or 
Withdrawal (if applicable). 
 
 
*Hybrid systems are systems that use device components from different manufacturers (e.g. St Jude 
Medical and Medtronic). 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
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1.1 
STUDY FLOW CHART 
 
1.2 
STUDY CONTACTS 
 
 
 
 
 
 
 
 
 
  
 
 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
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 BACKGROUND AND JUSTIFICATION FOR CLINICAL STUDY 
2.0
Deep brain stimulation (DBS) is widely used to treat motor symptoms in patients with advanced 
Parkinson’s disease (PD) (Aström, Stereotact Funct Neurosurg 2010). DBS is the surgical treatment of 
choice for Parkinson’s disease (PD) patients with medication resistant motor fluctuations, dyskinesias 
and refractory tremor (Krack, N Engl J Med. 2003; Lang, Mov Disord. 2006; Lang, Mov Disord. 2002)  
DBS of the subthalamic nucleus (STN) has been shown to improve not only the primary motor 
symptoms of PD and levodopa-induced motor complications, but also overall quality of life.  DBS is an 
adjustable treatment, with the potential to optimize the treatment through implantable pulse generator 
(IPG) programming options, by changing the polarity, amplitude (V or mA), pulse width (µsec), and 
frequency (Hz) of the device.  
 
As problematic side effects after initiation of DBS therapy with first generation unregulated DBS devices 
have included difficulties in speech, gait and some features of cognition (C Daniels, Movement 
Disorders 2010; Krack; N Engl Med. 2003). It has been shown that DBS treatment in the Subtalamic 
Nucleus (STN) can affect some aspects of intelligibility of speech depending on different IPG 
programming parameters. A particular cognitive side-effect most frequently observed after surgery can 
be a decline in the verbal fluency tasks in both the phonemic and semantic domain (Castelli, J 
Neurology 2007). Parameter settings shown to induce significant reduction of PD symptoms may in 
some cases result in either uninfluenced or intelligibility of speech. (Törnqvist, Movement Disorder 
2005). A hypothesis explaining the worsening effect of STN-DBS on speech indicates the decline is 
related to the influence of the stimulation (current spread) on sounding neural pathways and this 
system includes cognitive circuits (Tripoliti, Movement Disorders 2008; Woods Neuropsychology 
Review, 2002) 
 
Large similarities between gait patterns and speech involvement in PD and their response to STN-DBS 
and levodopa treatment have been demonstrated. The walking cadence and speech index of velocity 
tend to be lower in patients and are not significantly improved by STN-DBS or levodopa (Cantiniaux J 
Neurol Neurosurg Psychiatry 2010).  
 
DBS is widely performed using voltage-controlled devices, which were refined from those utilized in 
cardiac pacing (Cheung & Tagliati, 2010). Such electrical stimulation can be supplied to the brain either 
using a constant current or a constant voltage power source. A constant current source provides a 
consistent current to the tissue by adjusting the voltage in response to the tissues impedance. A 
constant voltage source adjusts the current in response to a change in impedance thereby maintaining 
the voltage constant.  There is evidence that constant current stimulation may provide more accurate 
control of the electrical field spread produced by these devices through adjustments for the 
heterogeneity in tissue impedance (Lempka, 2010). 
 
Published research investigating the influence of DBS on parkinsonian patient’s speech, gait and 
cognition has been performed applying constant voltage implantable impulse generators (IPGs). 
Patients, previously implanted with constant voltage devices and re-implanted (at IPG end of life) with a 
Brio™ constant current system have reported post-operative improvements in speech according to the 
feedback received from their implanting physicians.  
 
This post-marketing evaluation has been designed to consistently investigate the subject’s preference 
when switching from a Medtronic® constant voltage or constant current device to a St Jude Medical 
Infinity™ or St Jude Medical BrioTM constant current system. As electrodes will not be re-positioned, 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
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differences in subject’s preference are to be explained by the difference in shape of the delivered pulse 
or waveform between the two systems. 
 
  RISKS AND BENEFITS OF THE CLINICAL STUDY 
3.0
3.1 
DESCRIPTION OF SUBJECT POPULATION 
The subject population enrolled in this investigation will be comprised of male and female subjects. 
Subjects have to meet the specific eligibility criteria in order to participate in the study. 
3.2 
ANTICIPATED CLINICAL BENEFITS 
If subjects agree to take part in this study, there may or may not be direct medical benefits to 
individual subjects. The scientific use of the data, gathered from this study, may help the 
researchers discover better ways of programming movement disorder subjects and improving 
quality of life. 
3.3 
ANTICIPATED ADVERSE EVENTS AND ADVERSE DEVICE EFFECTS 
The replacement of a DBS IPG involves risks. In addition to those risks commonly associated with 
surgery, the following risks are also associated with implantation and / or use of the device:  
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 the 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.   
Complications may occur leading in some cases to surgical revision or explant of the system.  
Possible 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 due to a change in electrode positions, loose electrical connections, or 
lead or extension fraction 
• 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 with the device 
• Deep brain stimulation system malfunction or dislodgement 
• Spontaneous turning on or off of the IPG 

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Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
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• 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 PD 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 and language impairment including aphasia, dysphagia, dysarthria and hypophonia 
• Cognitive impairment including attention deficit, disorientation, abnormal thinking, hallucinations, 
amnesia, delusions, dementia, inability to act or make decisions, physic 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 PD and essential tremor that is reversible, and adaptable.  

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
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The targeted study population consists of subjects who have been previously implanted with a 
Medtronic® DBS device and re-implanted at the IPG’s end of life with a St Jude Medical InfinityTM 
DBS or St Jude Medical BrioTM DBS constant current system. Subject’s preference will be collected 
for the 2 stimulation modes (i.e. constant voltage and constant current).  
Effects of the DBS with constant current as well as with a constant voltage device are considered 
safe, non-destructive and reversible. The frequency and severity of procedural risks and 
complications related to the replacement of a Medtronic® device (constant voltage or constant 
current ) by an Infinity™ device or BrioTM device (constant current) are expected to be similar to 
those  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 
There are no known possible interactions with concomitant medical treatments. The following 
procedures are contra-indicated for patients that have been implanted with this device:  
• Diathermy (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy) 
• MR imaging is contra-indicated for patients with an implanted neurostimulation system. 
Please refer to the InfinityTM and BrioTM 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 additional risks for the subjects expected in 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 
4.0
4.1 
PURPOSE 
The purpose of this clinical study is to evaluate subject’s preference for different stimulation 
modes (i.e. constant voltage and constant current).  
4.2 
STUDY DESIGN AND SCOPE 
This post-marketing evaluation has been designed to consistently investigate the subject’s 
preference when switching from a Medtronic® device (constant voltage) to a St Jude Medical 
Infinity™ device or a St Jude Medical BrioTM DBS system (constant current system). As electrodes 
are not re-positioned, differences in subject’s preference are to be explained by the difference in 
shape of the delivered pulse or waveform between the two systems. 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
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This is the first known study to evaluate the effects of constant voltage versus constant current 
between 2 manufacturers in PD subjects with regards to subject’s preference and symptom control. 
Subjects currently implanted with a Medtronic® device, who have been recommended as a 
candidate for IPG replacement by the Investigator 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 the study inclusion criteria and none of the 
exclusion criteria, he/she will be informed about the study to determine if he/she is interested in 
participating. After the subject signs the informed consent, he/she is considered enrolled in the 
study. The IPG replacement will be done according to the routine time point for IPG replacements.  
During the surgery, the leads and extensions will not be re-positioned/revised. The IPG will be 
implanted according to the physician’s standard operating procedures. The IPG will be activated 
and programmed using the Clinician Programmer by trained personnel. The subject may be given 
a Patient Controller, dependent on the physician’s recommendation for patient care. Subjects will 
return for evaluation at 3 and 12 months post-implant for follow-up visits. This study is for data 
collection purposes and there are no additional risks to subjects that participate in this study than 
those risks associated with deep brain IPG replacement. 
The study will be conducted in approximately 20 centers in Europe, Australia and the United 
States. 
 
4.2.1 
Number of subjects required to be included in the study 
  Approximately 170 subjects will be enrolled in the study. 
 
4.2.2 
Estimated time needed to enroll this subject population 
 
 
 
4.3 
OBJECTIVES 
4.3.1 
Primary Objective 
 
The primary objective of the study is to demonstrate subject’s preference for a stimulation 
modality. 
4.3.2 
Secondary Objective 
The secondary objective of the study is to demonstrate the safety of the hybrid DBS system. 
 
4.4 
ENDPOINTS 
4.4.1 
Primary Endpoint 
The primary endpoint is the proportion of subjects who indicate preference on constant current 
over constant voltage at the 3 Month follow-up visit. 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 15 of 41 
 
4.4.2 
Secondary Endpoint 
The secondary endpoint is the rate of safety events related to battery replacement procedures  
for hybrid systems. 
 
4.4.3 
Descriptive Endpoints 
The following data will be collected: 
• 
The change in Speech Handicap Index at 3 and 12 Months compared to Baseline; 
• 
The change in total UPDRS score and the individual UPDRS components at 3 and 12 Months 
compared to Baseline; 
• 
The change in Levodopa medication at 3 and 12 Months compared to Baseline; 
• 
The change in FOGQ scores at 3 and 12 Months compared to Baseline; 
• 
The change in Tinetti Test scores at 3 and 12 Months compared to Baseline; 
• 
The change in Berg Balance Scale scores at 3 and 12 Months compared to Baseline; 
• 
The change in PDQ-39 scores at 3 and 12 Months compared to Baseline; 
• 
Proportion of subjects who indicate satisfaction with constant current at 3 and 12 Months; 
• 
Proportion of caregivers  who indicate satisfaction with constant current at 3 and12 Months; 
• 
Proportion of subjects who indicate preference on constant current over constant voltage at 12 
Months; 
• 
Summary of Health Economic Data between constant current and constant voltage. 
 
4.5 
INCLUSION AND EXCLUSION CRITERIA 
A subject, who meets all of the inclusion criteria, and none of the exclusion criteria, is eligible to 
participate in this study.  
 
All subjects enrolled in the clinical study (including those withdrawn from the clinical study or lost to 
follow-up) will be accounted for and documented, assigning an identification code linked to their names, 
alternative identification or contact information. 
 
This log will be kept up to date throughout the clinical study by the principal investigator or his/her 
authorized designee. To ensure subject privacy and confidentiality of data this log must be maintained 
throughout the clinical study at the clinical site. 
 
To participate in this clinical subject, the subject must meet all of the following inclusion criteria: 
4.5.1 
Inclusion Criteria 
 
Subject (and caregiver,if applicable) signed the approved Informed Consent; 
 
Subject is ≥ 18 and ≤ 74 years of age;  
 
Subject is bilaterally treated with deep brain stimulation (DBS) in the subthalamic nucleus 
(STN) using a constant voltage device (i.e. Soletra™, Itrel™, Kinetra™, ActivaPC™ or 
ActivaRC™ IPG) and is responding satisfactory to CV stimulation in the Investigators opinion; 
 
In the physician’s opinion, the subject is a suitable candidate for an IPG replacement with 
different stimulation paradigm; 
 
Subject needs and/or requests an IPG replacement within 12 months after consent and the 
current IPG has at least 2.6 V output left (i.e. approx. 30% of full battery capacity) at the time 
of subject enrollment;  
 
PD symptom onset is no longer than 20 years; 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 16 of 41 
 
 
Subject has a Hoehn & Yahr score <IV (on stim); 
 
Subject with a normal cognitive function (MMSE ≥25); 
 
Subject is fluent speaker (as judged by the investigator) of the language spoken in the country 
where the investigational site is located.  
 
Subjects are not eligible for clinical study participation if they meet any of the following exclusion 
criteria: 
4.5.2 
Exclusion Criteria 
 
IPG battery has less than 30% battery life at the time of consent;  
 
Need to replace or reposition the leads or extensions during the IPG replacement procedure; 
 
Subject had >10 recurrent falls experienced in the 3 months prior to consent; 
 
Subject is unwilling to change to a St Jude Medical InfinityTM or BrioTM DBS system for the IPG 
replacement; 
 
Subject is unable to attend the study visits. 
 
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. 
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.  
 
4.7 
INFORMED CONSENT PROCESS 
4.7.1 
General process 
Prior to enrolling in the clinical study and conducting study-specific procedures, all subjects will be 
consented, as required by applicable regulations and the center’s IRB/EC.  Informed consent 
must be obtained from each subject, and in case they have a caregiver, also from the caregiver 
prior to any study related procedures. The consent form must be signed and dated by the subject, 
the caregiver (if applicable), and by the person obtaining the consent. 
 
The principal investigator or his/her authorized designee will conduct the Informed Consent 
Process. This process will include a verbal discussion with the subject on all aspects of the 
clinical study relevant to the subject’s decision to participate in the clinical study.  
 
The subject (and the caregiver, if applicable) shall be provided with the informed consent form 
that is written in a language that is understandable to the subject (and the caregiver, if applicable) 
and has been approved by the center’s IRB/EC.  Failure to obtain informed consent from a 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 17 of 41 
 
subject prior to study enrollment should be reported to St. Jude Medical within 5 working days and 
to the reviewing center’s IRB/EC/ consistent with the center’s IRB/EC reporting requirements.  
 
 DEVICE UNDER INVESTIGATION AND CONTROL/COMPARATORS  
5.0
5.1 
DEVICE DESCRIPTION 
In this study, the commercial available Infinity TM IPG with compatible header, the BrioTM IPG and the  
pocket adapter that are compatible with the Medtronic® extensions will be used in this study. 
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. Physicians use the clinician programmer to create and 
modify a program for a patient. Subjects use the patient controller to control their prescribed programs. 
The patient magnet can turn the IPG on and off if the physician enables this functionality. 
 
The Infinity™ 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 ‘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.  The 
models to be used in this study contain a header that is designed to allow the IPG to connect to 
Medtronic® extensions and/or leads that meet the compatibility guidelines.  
 
The clinician programmer Application is a software application running on an iPad which is used by a 
clinician to wirelessly connect to InfinityTM IPGs to establish or modify the stimulation settings for a 
subject.  
 
The patient controller is an off-the-shelf touch screen device (iPod Touch) with a SJM designed mobile 
Application software. Subjects use the patient controller to control their prescribed programs. 
Description of the devices and instructions for use can be found in the User’s Manual. 
 
The components of the Brio™ DBS IPG to be used in this study include BrioTM DBS rechargeable IPG, 
a Pocket AdaptorTM, a trial stimulator, a clinician programmer and a patient controller. 
Description of the devices and instructions for use can be found in the User’s Manual. 
 
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. 
 
 
 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 18 of 41 
 
 PROCEDURES 
6.0
6.1 
STUDY FLOW CHART 
Figure 2: Flow Chart 
 
6.2 
PROCEDURES 
The clinical study will be conducted in accordance with the CIP.  All parties participating in the conduct 
of the clinical study will be qualified by education, training, or experience to perform their tasks and this 
training will be documented appropriately. 
 
The clinical study will not commence until St. Jude Medical receives written approval from the IRB/EC 
and relevant regulatory authorities and all required documents have been collected from the site(s). 
 
 
 
 
 
 
 
 
 
 
 
 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 19 of 41 
 
 
Table 1: List of all study specific activities/procedures 
 
 
 
Procedure 
 
Enrollment 
 
Baseline 
IPG replacement 
& Programming 
 
3 M FU 
(+-30 days) 
12 M FU 
(+-30 days) 
IC signed (Subject & 
Caregiver**) 
X 
 
 
 
 
Inclusion/Exclusion 
Criteria 
X 
 
 
 
 
Demographics  
 
X 
 
 
 
Medical History 
 
X 
 
 
 
Medication Review 
 
X 
 
X 
X 
Health Economic Data 
 
X 
 
 
X 
(S)ADEs  
 
 
X** 
X** 
X** 
Withdrawal 
 
X** 
X** 
X** 
 
Subject’s Preference 
 
 
 
X 
X 
QUESTIONNAIRES 
 
 
 
 
 
UPDRS I,II,III,IV 
On Med On Stim 
 
X 
 
X 
X 
UPDRS Part  III  
On Med Off Stim 
 
X 
 
X 
X 
Satisfaction of Therapy 
(Subject & Caregiver**) 
 
X 
 
X 
X 
PDQ-39 
 
X 
 
X 
X 
TESTS 
 
 
 
 
 
Speech Handicap Index 
 
X 
 
X 
X 
Gait: 
1.Tinetti 
2. Freezing of Gait 
3. Berg Balance Scale 
 
X 
 
 
 
X 
X 
PROGRAMMING 
 
 
 
 
 
Programming Settings 
 
 
X* 
 
X* 
X* 
Initial 
testing/programming 
 
 
X 
 
 
SURGERY/IMPLANT 
 
 
 
 
 
Implant Information 
 
 
X 
 
 
Unscheduled Visit:  is defined as a follow up that is not explicitly requested by the protocol. Subjects may be asked to return to the 
clinic for unscheduled study visit. The following information will be recorded: Reason for visit, Action taken, Record program settings 
(when re-programming has been done). 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 20 of 41 
 
*Before the questionnaires and the tests, the program settings for the subject should be recorded. After 
the questionnaires and the tests, the program settings for the subject may be optimized. The evaluator 
will decide when the settings are optimum. This might take several sessions. 
**If applicable 
 
Informed Consent Procedure and Inclusion/Exclusion Criteria:  
Subject’s eligibility criteria and Informed consent Procedure is performed at the Enrollment visit.  
 
Subject Demographics:  
Subject’s Age, Weight, Height and Gender; will be collected at the Baseline 1 visit.  
 
Medical History:  
Diagnosis, 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.  
 
Medication: 
Subject’s current medications for the indication will be collected at the Baseline visit and at the 3 and 12 
Month Follow- Up visit. 
 
Subject Data:  
 
Subject’s Preference will be collected at 3 and 12 Month Follow-Up visit. 
 
UPDRS I (Mentation, Behavior and Mood ), UPDRS II (Activities of Daily Living), UPDRS III 
(Motor exam) and UPDRS IV (Complications of Therapy) total scores ‘On Medication/On 
Stimulation’ will be collected at Baseline visit, 3 and 12 Month Follow- Up visits;   
 
UPDRS III Motor exam ‘On Medication/Off Stimulation’ will be collected at Baseline visit, 3 and 
12 Month Follow- Up visit;  
 
Parkinson’s Disease Questionnaire PDQ-39 (Quality of Life) will be completed at Baseline, 3  
and 12 Month Follow- Up visit;  
 
Speech Handicap Index (SHI) will be collected at Baseline, 3 and 12 Month Follow- Up visit; 
 
Freezing of Gait Questionnaire (FOGQ) will be completed at Baseline, 3 and 12 Month Follow -
Up visit; 
 
Tinetti Test will be assessed at Baseline, 3 and 12 Month Follow- Up visit; 
 
Berg Balance Scale will be assessed at Baseline, 3 and 12 Month Follow-Up visit; 
 
Satisfaction of Therapy Questionnaire for the subject will be completed at Baseline, 3 and 12 
Month Follow- Up visit. 
 
Caregiver: 
Satisfaction of Therapy Questionnaire for the caregiver will be completed at Baseline, 3 and 12 Month 
Follow- Up visit (if subject has a caregiver). 
 
Health Economic data: 
Health Economic data will be collected at Baseline and 12 Month Follow- Up visit. 
 
Programming: 
Stimulation settings will be collected at each visit. 
Initial programming parameters and settings will be collected at the IPG Replacement visit.  
The frequency, pulse width and # of contacts (monopolar/bipolar) of  the stimulation should be kept 
constant between the constant voltage and the constant current stimulation. 
Additional programming sessions may be required during the study to optimize the therapy, 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 21 of 41 
 
 
Implant: 
Implant data will be collected at the IPG Replacement visit. 
 
Please find here below a summary description of the questionnaires and tests:  
 
Speech Handicap Index (SHI):  
The SHI is a validated questionnaire with 30 items on speech related problems in daily life. 
 
The Unified Parkinson’s Disease Rating Scale (UPDRS): 
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 Examination 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. 
 
Freezing of Gait Questionnaire (FOGQ): 
The FOGQ is a validated questionnaire with the purpose of identifying the freezing of gait. 
 
Tinetti Test: 
A measurement of functional ability that incorporates observation of performance of 13 activities with a 
focus on gait and balance. The activities include sitting, rising from a chair, standing, turning, reaching 
up, and bending down. The rating scale is normal, adaptive, or abnormal and is often used to assess 
the risk of falling. 
 
Berg Balance Scale (BBS): 
The test comprises a set of 14 simple balance related tasks, ranging from standing up from a sitting 
position, to standing on one foot. The degree of success in achieving each task is given a score of zero 
(unable) to four (independent), and the final measure is the sum of all of the scores 
 
Parkinson’s Disease Questionnaire (PDQ-39): 
A disease specific instrument designed to measure aspects of health that are relevant to subjects with 
PD, and which may not be included in general health status questionnaires. The PDQ-39 is a self-
administered questionnaire, which comprises 39 questions addressing eight dimensions of health that 
subjects consider to be adversely affected by the disease. 
 
Satisfaction of Therapy Questionnaire:  
Subject and caregiver (if applicable) will be asked to subjectively assess the rate of satisfaction with the 
deep brain stimulation therapy by completing a questionnaire. 
 
 
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 subjects to 
determine subject eligibility for the study 
• 
The inclusion/exclusion criteria will be verified. 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 22 of 41 
 
• 
If a subject does not meet all inclusion criteria or meets any of the exclusion criteria, the subject 
cannot participate in the study and cannot be enrolled.  
• 
The subject is enrolled in the study when the subject signs the EC/IRB approved consent form. 
 
Record enrollment information (name of the study, date of consent and inclusion/exclusion information) 
in the hospital records and complete the Enrollment form electronically in a timely manner (preferably 
within 5 days after enrollment). 
 
As soon as the subject signs the Patient Informed Consent, adverse events need to be reported 
according to the guidelines in this CIP. 
 
In case the subject was consented to participate in the study, but does not meet inclusion/exclusion 
criteria, and did not receive an IPG replacement, the subject should be withdrawn and a withdrawal 
form must be completed. The subject will resume his/her regular standard of care with his/her 
physician. 
 
In case the subject was consented to participate in the study, but does not meet inclusion/exclusion 
criteria, and did receive an IPG replacement, then this is considered a protocol deviation. A protocol 
deviation form needs to be completed and the Sponsor must be informed. The EC/IRB and Competent 
Authority (CA), if applicable, should be notified appropriately about any deviations with regard to the 
violation of inclusion/exclusion criteria.  
 
The following data will be collected: 
 
Informed Consent signed (Subject & Caregiver [if applicable]) 
 
Inclusion/Exclusion Criteria  
 
Demographics   
 
Medical History  
 
6.4 
BASELINE VISIT  
The following information will be collected at the Baseline visit.  
Baseline visit can be combined with Enrollment visit. 
The following data will be collected: 
 
Medication  
 
Health Economic Data 
 
Speech Handicap (SHI) 
 
Unified Parkinson’s Disease Rating Scale ‘On Med/On stim’. (“On” state is defined as 
approximately 30 minutes after a subject takes anti-Parkinson medication when both the 
clinician and the subject indicate that the medication dose is effective.) 
 
Unified Parkinson’s Disease Rating Scale part III ‘On Med/Off Stim’  
 
Freezing of Gait Questionnaire (FOGQ)  
 
Tinetti Test 
 
Berg Balance Scale (BBS) 
 
Parkinson’s Disease Questionnaire (PDQ-39)  
 
Satisfaction of Therapy Questionnaire for the subject 
 
Satisfaction of Therapy Questionnaire for the caregiver, if applicable 
 
Record programming settings 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 23 of 41 
 
 
Adverse events or Withdrawal (if applicable) 
 
 
6.5 
IPG REPLACEMENT VISIT & PROGRAMMING 
The implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM 
BrioTM DBS system according to the standard surgical procedures and instructions for use. The time 
point for the replacement will be decided by the physician according to their standard procedure.   
Intra-operative assessments and the initial CC programming session will be performed according to 
each individual site’s standard procedure.   
The frequency, pulse width and number of contacts (monopolar/bipolar) of the stimulation should be 
kept constant between the constant voltage and the constant current stimulation. 
Additional programming sessions may be required to optimize the therapy. 
The following data will be collected:  
 
Implant information 
 
Initial programming information 
 
Adverse Events or Withdrawal (if applicable) 
 
6.6 
3 MONTH FOLLOW UP VISIT (3 months +/- 30 days after IPG replacement) 
The current programming settings will be recorded before the questionnaires and tests. 
 
The following data will be collected: 
 
 
Subject’s Preference 
 
Speech Handicap Index (SHI) 
 
Unified Parkinson’s Disease Rating Scale ‘On Med/On Stim’ (“On” state is defined as 
approximately 30 minutes after a subject takes anti-Parkinson medication when both the 
clinician and the subject indicate that the medication dose is effective.)  
 
Unified Parkinson’s Disease Rating Scale part III ‘On Med/Off Stim’  
 
Freezing of Gait Questionnaire (FOGQ)  
 
Tinetti Test  
 
Berg Balance Scale (BBS) 
 
Parkinson’s Disease Questionnaire (PDQ-39)  
 
Satisfaction of Therapy Questionnaire for the subject 
 
Satisfaction of Therapy Questionnaire for the caregiver, if applicable 
 
Medication 
 
Adverse events or Withdrawal (if applicable) 
 
After the questionnaires and the tests, the SJM Infinity TM or BrioTM DBS system parameters shall be 
optimized if needed. The optimized settings will be recorded. 
 
6.7 
12 MONTH FOLLOW UP VISIT (12 months +/- 30 days after IPG replacement) 
This visit will also serve as the end-of-study assessment. 
The current programming settings will be recorded before the questionnaires and tests. 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 24 of 41 
 
 
The following data will be collected:  
 
 
Subject’s Preference 
 
Unified Parkinson’s Disease Rating Scale ‘On Med/On Stim’ (“On” state is defined as 
approximately 30 minutes after a subject takes anti-Parkinson medication when both the 
clinician and the subject indicate that the medication dose is effective.)  
 
Unified Parkinson’s Disease Rating Scale part III ‘On Med/Off Stim’  
 
Freezing of Gait Questionnaire (FOGQ)  
 
Tinetti Test  
 
Berg Balance Scale 
 
Parkinson’s Disease Questionnaire (PDQ-39)  
 
Satisfaction of Therapy Questionnaire for the subject 
 
Satisfaction of Therapy Questionnaire for the caregiver, if applicable 
 
Medication 
 
Health Care Economic Data 
 
Adverse events or Withdrawal (if applicable) 
 
6.8 
UNSCHEDULED VISIT 
An Unscheduled Visit is defined as a follow up that is not explicitly requested by the protocol.  
Subjects may be asked to return to the clinic for unscheduled study visit.  
 
The following information will be recorded:  
 
Reason for visit 
 
Action taken 
 
Record program settings (when re-programming has been done) 
 
No specific assessment is required for this visit. If applicable, the AE or Withdrawal will be documented. 
 
6.9 
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 the study visits. 
 
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 or the subject in completion of the questionnaires  
 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 25 of 41 
 
6.10 
SUBJECT STUDY COMPLETION 
When the subject completes the 12-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.  
 
6.11 
ANY KNOWN OR FORSEEABLE FACTORS THAT MAY COMPROMISE THE OUTCOME OF 
THE CLINICAL STUDY OR THE INTERPRETATION OF THE RESULTS 
All foreseeable factors that may compromise the outcome have been taken into account by clinical 
study design and well-defined subject selection criteria. 
 
Subject 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 subject visit calendars. 
 
6.12 
CRITERIA AND PROCEDURES FOR SUBJECT WITHDRAWAL OR DISCONTINUATION 
Subjects must be informed about their right to withdraw from the study at any time and for any reason 
without sanction, penalty or loss of benefits to which the subject is otherwise entitled and withdrawal 
from the study will not jeopardize their future medical care or relationship with the investigator. Subjects 
will be asked to specify the reason for the termination, but have the right not to answer. 
 
The investigator may decide to withdraw a subject from the study at any time with reasonable rationale. 
The subject’s future care will not be influenced by a decision, voluntary or otherwise, to withdraw from 
the study. All reasonable efforts should be made to retain the subject in the clinical study until 
completion of the study. 
 
Reasons for subject’s withdrawal include, but are not limited to: 
 
 
Subject needs an unplanned revision of the leads and/or extensions during IPG replacement  
 
Subject refuses to continue participating in the study 
 
Subject does not meet the inclusion/exclusion criteria and does not require additional follow-up for 
safety reasons. 
 
Subject is deceased (cause must be documented) 
 
Subject’s non-compliance 
 
Subject’s participation is terminated by the PI or investigator, although the subject consented, 
since participation is no longer medically appropriate 
 
Subject is ‘lost to follow up’: Subject does not adhere to the scheduled follow up visits but has not 
explicitly requested to be withdrawn from the clinical study. (This does not apply to missed visits). 
Site personnel should at all times make all reasonable efforts to locate and communicate with the 
subject in order to achieve subject compliance to the scheduled follow up visits: 
1.  A subject will be considered ‘Lost to Follow Up’ after a minimum of 2 phone calls of a 
physician or delegate at the investigational site to the subject or contact. These 2 phone calls 
need to be documented in the subject’s hospital records. 
2.  If these attempts are unsuccessful, a letter should be sent to the subject’s last known 
address or general practitioner (GP) and a copy of this letter should be maintained in the 
subject’s hospital records. 
 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 26 of 41 
 
Note: If a subject misses one or more of the scheduled follow up visits (inclusive of the assigned visit 
windows), this will be considered as a missed visit. The subject may therefore still return for subsequent 
visits and will not be excluded from the study. 
 
If a subject withdraws from the clinical study, the site will record the subject’s reasons for withdrawal, on 
a Withdrawal CRF. 
 
When subject withdrawal from the clinical study is due to an adverse event the subject will be followed 
until resolution of that adverse event or determination that the subject’s condition is stable. The status 
of the subject’s condition should be documented at the time of withdrawal.   
 
 COMPLIANCE TO CIP 
7.0
7.1 
STATEMENTS OF COMPLIANCE 
The investigator will not start enrolling subjects or requesting informed consent from any subject prior 
to obtaining IRB/EC approval and Competent Authority approval, if applicable, and authorization from 
the sponsor in writing for the study. 
 
In case additional requirements are imposed by the IRB/EC or Competent Authority, those 
requirements will be followed, if appropriate. If any action is taken by an IRB/EC, and regulatory 
requirements with respect to the study, that information will be forwarded to St. Jude Medical. 
 
 
7.2 
ADHERENCE TO THE CLINICAL INVESTIGATION PLAN 
A deviation is defined as an event where the clinical investigator, site personnel, sponsor or sponsor 
representative did not conduct the clinical study according to the Clinical Investigational Plan, IRB/EC 
requirements or the Investigator Agreement. The investigator is not allowed to deviate from the CIP, 
except as specified under emergency circumstances.   
 
In some cases, failure to comply with the CIP may be considered failure to protect the rights, safety and 
well-being of subjects, since the non-compliance exposes subjects to unreasonable risks. For example, 
failure to adhere to the inclusion/exclusion criteria: these criteria are specifically defined by the Sponsor 
to exclude subjects for whom the device is not beneficial and the use involves unreasonable risks. This 
may be considered failure to protect the rights, safety and well-being of the enrolled subject. Similarly, 
failure to perform safety assessments intended to detect adverse events may be considered failure to 
protect the rights, safety and well-being of the enrolled subject. Investigators should seek minimization 
of such risks by adhering to the CIP. 
 
Simultaneously, in the event that adhering to the CIP might expose the subject to unreasonable risks, 
the investigator is also required to protect the rights, safety and well-being of the subject by intentionally 
deviating from the requirements of the CIP, so that subjects are not exposed to unreasonable risks.  
 
It is the responsibility of the investigator to provide adequate medical care to a subject enrolled in a 
study. 
 
Regulations require that the PI maintain accurate, complete, and current records, including documents 
showing the date of and reason for every deviation from the Clinical Investigational Plan.  Relevant 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 27 of 41 
 
information for each deviation will be documented on a Deviation Case Report Form. The site will 
submit the CRF to St. Jude Medical. 
 
Regulations require Investigators obtain approval from St. Jude Medical and the IRB/EC [as required] 
before initiating changes in or deviations from the protocol, except when necessary to protect the life or 
physical well-being of a subject in an emergency.  Under emergency circumstances, deviations from 
the CIP to protect the rights, safety and well-being of human subjects may proceed without prior 
approval of the sponsor and the EC. Such deviations shall be documented and reported to the sponsor 
and the EC as soon as possible, but no later than 5 working days. 
 
Prior approval must be requested when the PI anticipates, contemplates, or makes a conscious 
decision to depart from the CIP, except when unforeseen circumstances are beyond the investigator’s 
control (e.g. a subject who fails to attend a scheduled follow-up visit, a subject is too ill to perform a 
CIP-required test, etc.).  All deviations, including those beyond the investigator’s control, must be 
reported on a CRF. 
 
To obtain approval, the Principal Investigator may call or email and discuss the potential deviation with 
St. Jude Medical or designee prior to initiating any changes.   
 
All deviations must be reported to appropriate regulatory authorities in specified timelines (if 
appropriate). 
 
 
7.3 
REPEATED AND SERIOUS NON-COMPLIANCE 
In the event of repeated non-compliance or a one-time serious non-compliance, as determined by the 
Sponsor, a Clinical Research Associate or clinical representative will attempt to secure compliance by 
one or more of the following actions: 
 
Visiting the investigator 
 
Contacting the investigator by telephone 
 
Contacting the investigator in writing 
 
Retraining of the investigator 
 
If an investigator is found to be repeatedly non-compliant with the signed agreement, the CIP or any 
other conditions of the clinical study, the Sponsor will either secure compliance or, at its sole discretion, 
terminate the investigator’s participation in the clinical study. 
 
 ADVERSE EVENTS  
8.0
8.1 
DEFINITIONS 
8.1.1 
Medical device 
Any instrument, apparatus, implement, machine, appliance, implant, software, material or other similar 
or related article 
 
Intended by the manufacturer to be used, alone or in combination, for human beings for one or 
more of the specific purpose(s) of 
o Diagnosis, prevention, monitoring, treatments or alleviation of disease, 
o Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury, 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 28 of 41 
 
o Investigation, replacement, modification, or support of the anatomy or of a physiological 
process, 
o Supporting or sustaining life, 
o Control of conception, 
o Disinfection of medical devices and 
 
Which does not achieve its primary intended action in or on the human body by pharmacological, 
immunological or metabolic means, but which may be assisted in its intended function by such 
means 
 
8.1.2 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including 
abnormal laboratory findings) in subjects, users or other persons, whether or not related to the 
investigational medical device under study. 
 
This definition includes events related to the investigational medical device or the comparator. 
This definition includes events related to the procedures involved. 
 
8.1.3 
Serious Adverse Event (SAE) 
An adverse event that led to: 
 
Death 
 
A serious deterioration in the health of the subject, that either resulted in: 
o A life-threatening illness or injury OR 
o A permanent impairment to a body structure or a body function OR 
o An in-patient or prolonged hospitalization OR 
o A medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body  
o A malignant tumor (in applicable countries only) 
 
Fetal distress, fetal death or a congenital abnormality or birth defect 
Note: A planned hospitalization for a pre-existing condition, or a procedure required by the CIP is 
not considered a serious adverse event. 
 
8.1.4 
Adverse Device Effect (ADE) 
An adverse event related to the use of an investigational medical device. 
 
This definition includes adverse events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the investigational medical 
device. 
 
This definition includes any event resulting from the use error or from intentional misuse of the 
investigational medical device. 
 
8.1.5 
Serious Adverse Device Effect (SADE) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse 
event. 
 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 29 of 41 
 
For unexpected failure modes or unexpected adverse events, the site should follow their standard 
reporting practices for medical device reporting (MDR)/ Vigilance reporting for medical devices per 
the regulations. 
 
8.2 
PROCEDURE FOR ASSESSING, RECORDING, AND REPORTING ADVERSE EVENTS, 
DEVICE DEFICIENCIES/COMPLAINTS, ADVERSE DEVICE EFFECTS, SERIOUS ADVERSE 
EVENTS, AND SERIOUS ADVERSE DEVICE EFFECTS:  
Safety surveillance within this study and the safety reporting both performed by the investigator, starts 
as soon as the subject is enrolled in this study (date of signature of the informed consent). The safety 
surveillance and the safety reporting will continue until the last investigational visit has been performed, 
the subject is deceased, the subject/investigator concludes his participation into the study or the 
subject/investigator withdraws the subject from the study, except as otherwise specified in the CIP. 
 
Adverse event data as well as deaths will be collected throughout the clinical study and will be reported 
to the Sponsor through the EDC system. The Investigator will record adverse events on the appropriate 
case report forms.  
 
Records relating to the subject’s subsequent medical course must be maintained and submitted (as 
applicable) to the Sponsor until the event has subsided or, in case of permanent impairment, until the 
event stabilizes and the overall clinical outcome has been ascertained. Adverse events will be 
monitored until they are adequately resolved. The status of the subject’s condition should be 
documented at each visit.   
 
The investigator will report the event to the IRB/EC per their reporting requirements.  
 
For this study, reportable events to sponsor are considered:  
All procedure or device related Adverse Events (whether or not the event is considered serious). 
 
ADEs (procedure/device related) 
 
SADEs (procedure/device related) 
 
These events will be reported to the Sponsor, as soon as possible in accordance to the local laws and 
regulations.  
 
The Sponsor will ensure that all events 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/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 effects in 
section 3.3 are associated with a DBS System. 
 
Events that will not be considered as SADE/ADE for the purposes of this study and should not be 
recorded in the AE CRF are as follows: 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 30 of 41 
 
• 
Hospital admission for the planned replacement of the IPG due to normal battery end of life.  
• 
Events directly linked to optimization/programming during the optimization/programming 
sessions. 
 
8.3 
SUBJECT DEATH 
8.3.1 
Procedure for recording and reporting subject death 
Investigators must report deaths to the sponsor as soon as possible in accordance to the local laws and 
regulations.  
Should death occur, the investigator is requested to record death information in the hospital records 
and immediately document the information on the Death case report form and submit to Sponsor 
through the electronic data capture (EDC) system deployed by St. Jude Medical. 
 
Subject death may be an outcome of a SAE: 
• 
Death is therefore related to an SAE: all efforts to obtain the SAE details should be made and the 
AE form must be completed or updated accordingly. 
• 
The subject’s death is an early conclusion of the subject’s participation in the study. Therefore, 
the investigator is requested to complete the Withdrawal form. 
• 
The investigator must notify the EC/IRB, if appropriate, in accordance with national and local laws 
and regulations. 
 
8.4 
DEVICE DEFICIENCY (DD) / COMPLAINTS  
The devices used in this study are CE-marked; therefore, the Device Deficiencies/ Complaints will not 
be collected through dedicated CRFs.  
 
For sites located outside of the United States:  
A Device Deficiency is defined as an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance. Device Deficiencies include malfunctions, use 
errors and inadequate labeling. Device Deficiencies in St. Jude Medical market-released products must 
be reported per St. Jude Medical product surveillance process. This product is a commercially released 
product; therefore, all Device Deficiencies need to be submitted through this process as well. The 
investigator or designee should notify the SJM Post market Surveillance Department by e-mailing the 
information about the Device Deficiency to 
. 
 
For sites located in the United States: 
A Complaint is defined as an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance. Complaints include malfunctions, use errors and 
inadequate labeling. Complaints in St. Jude Medical market-released products must be reported per St. 
Jude Medical product surveillance process. This product is a commercially released product; therefore, 
all Complaints need to be submitted through this process as well. The investigator or designee should 
notify the SJM post market Surveillance Department by e-mailing the information about the Complaint 
to 
 
 DATA MANAGEMENT 
9.0
Overall, the Sponsor will be responsible for the data handling. 
 
The sponsor and/or its affiliates will be responsible for compiling and submitting all required reports to 
governmental agencies. 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 31 of 41 
 
 
Data will be analyzed by the Sponsor and may be transferred to the Sponsor’s locations outside of 
Europe and/or any other worldwide regulatory authority in support of a market-approval application. 
St. Jude Medical respects and protects personally identifiable information that we collect or maintain for 
this clinical trial. The privacy of each subject and confidentiality of his/her information will be preserved 
in reports and when publishing any data. Confidentiality of data will be observed by all parties involved 
at all times throughout the clinical trial. 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, IRB/EC review and regulatory authority inspections.  As required, 
the Principal Investigator or institution will obtain permission for direct access to source documents from 
the subject, hospital administration and national regulatory authorities before starting the clinical study. 
 
9.1 
DATA MANAGEMENT PLAN 
A detailed Data Management Plan will be established to ensure consistency of the data. This document 
will include procedures used for data review, database cleaning, and issuing and resolving data 
queries. If appropriate, the DMP may be updated throughout the study duration. All revisions will be 
tracked and document controlled. 
CRF data will be captured in a validated electronic database management system hosted by St. Jude 
Medical.  
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 CRFs and in all required reports.  
 
9.2.2 
Recording data 
Source documents will be created and maintained by the investigational site team throughout the 
clinical study. 
 
The data reported on the CRFs will be derived from, and be consistent with, these source 
documents, and any discrepancies will be explained in writing. 
 
No data can be recorded directly in the CRFs.  
 
The CRFs will be validated (eCRF) by the authorized site personnel.  
 MONITORING  
10.0
Monitoring will be conducted according to St. Jude Medical’s Clinical Monitoring work instruction. 
Prior to beginning the clinical investigation, the Sponsor will contact the investigator or designee to 
discuss the clinical investigation and data requirements. A designated monitor will periodically review 
the subject records and associated source documents. The investigator shall make subject and clinical 
investigation records available to the clinical monitor for monitoring. 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 32 of 41 
 
 
 REGULATORY INSPECTIONS 
11.0
The investigator and/or delegate should contact St. Jude Medical immediately upon notification of a 
governmental agency inspection at the site. A clinical monitor or designee will assist the investigator 
and/or delegate in preparing for the audit. 
 
An investigator who has authority to grant access will permit authorized governmental agency 
employees, at reasonable times and in reasonable manner, to enter and inspect any establishment 
where devices are held (including any establishment where devices are used or where records or 
results are kept). 
 
An investigator, or any person acting on behalf of such a person with respect to the study, will permit 
authorized governmental agency employees, at reasonable times and in reasonable manner, to inspect 
and copy all records relating to the study. 
 
An investigator will permit authorized governmental agency employees to inspect and copy records 
that identify subjects, upon notice that governmental agency has reason to suspect that adequate 
informed consent was not obtained, or that reports required to be submitted by the investigator, to the 
Sponsor or IRB/EC have not been submitted or are incomplete, inaccurate, false or misleading. 
 
 
STATISTICAL CONSIDERATIONS 
12.0
 
12.1 
STATISTICAL DESIGN, HYPOTHESES, METHOD AND ANALYTICAL PROCEDURES 
The primary endpoint is the proportion of subjects who indicate preference on constant current over 
constant voltage at the 3 Month follow-up visit. 
 
12.1.1 Primary Endpoint 
 
 
 
    
 
 
 
 
12.1.2 Secondary Endpoint 
The rate of safety events related to battery replacement procedures for hybrid systems. 
 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 33 of 41 
 
The event rate will be summarized as (1) # events per patient-year of follow up and (2) incidence rate. 
The number of events per patient-year of follow-up will be calculated as the total number of safety 
events related to battery replacement procedures for hybrid systems divided by total follow-up duration 
from IPG replacement visit to either 12M visit or withdrawal visit (patient-years). The incidence rate (%) 
will be calculated as number of subjects who undergo IPG replacement and encounter safety events 
related to battery replacement procedure for hybrid system divided by total subjects who undergo IPG 
replacement.  
12.1.3 Descriptive Endpoints 
The following descriptive endpoints will be reported: 
 
The change in Speech Handicap Index at 3 and 12 Months compared to Baseline; 
 
The change in total UPDRS score and the individual UPDRS components at 3 and 12 Months 
compared to Baseline; 
 
The change in Levodopa medication at 3 and 12 Months compared to Baseline; 
 
The change in FOGQ scores at 3 and 12 Months compared to Baseline; 
 
The change in Tinetti Test scores at 3 and 12 Months compared to Baseline; 
 
The change in Berg Balance Scale scores at 3 and 12 Months compared to Baseline; 
 
The change in PDQ-39 Quality of Life scores 3 and 12 Months compared to Baseline; 
 
Proportion of subjects who indicate satisfaction with constant current at 3 and 12 Months; 
 
Proportion of caregivers  who indicate satisfaction with constant current at 3 and 12 Months; 
 
Proportion of subjects who indicate preference on constant current over constant voltage at the 
12 Month follow-up visit. 
 
Summary of Health Economic Data for constant current compared to constant voltage. 
 
12.2 
SAMPLE SIZE 
 
 
 
 
 
The target number of subjects for enrollment is 170 and the target number of subjects for the 
primary endpoint analysis is 115. 
 
12.3 
PROCEDURES FOR REPORTING ANY DEVIATION(S) FROM THE ORIGINAL STATISTICAL 
PLAN 
Any deviation from the statistical plan will be documented and reported. 
 
12.4 
THE SPECIFICATION OF SUBGROUPS FOR ANALYSIS 
No subgroup analyses are planned for this study. 
 
12.5 
PROCEDURES THAT TAKE INTO ACCOUNT ALL THE DATA 
All reported data will be used in the analysis for relevant endpoints.  Missing data will be excluded from 
the respective endpoint analysis. 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 34 of 41 
 
 
12.6 
THE TREATMENT OF MISSING, UNUSED, OR SPURIOUS DATA, INCLUDING DROP-OUTS 
AND WITHDRAWALS 
Analyses of each endpoint will be performed in subjects who provide complete data for each endpoint. 
Subject accountability for enrolled subjects will be performed prior to analyses of the primary and 
secondary endpoints.  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.     
 
12.7 
THE EXCLUSION OF PARTICULAR INFORMATION FOR THE TESTING OF THE 
HYPOTHESIS, if relevant  
There is no intent to exclude particular information for the testing of hypotheses. 
 
12.8 
IN MULTI-CENTER STUDIES, THE MINIMUM AND MAXIMUM NUMBER OF SUBJECTS TO 
BE INCLUDED FOR EACH CENTER 
Each participating will enroll at least one subject to a maximum of 30 subjects. 
 
 
DOCUMENT RETENTION 
13.0
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 minimum 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 
14.0
Study related documents such as, the Investigator Brochure (IB), Report of Prior Investigations (RPI) 
CIP, CRFs, Informed Consent form and other subject information, or other clinical study documents will 
be amended as needed throughout the clinical study, and a justification statement will be included with 
each amended section of a document. Proposed amendments to the CIP will be agreed upon between 
the Sponsor and the coordinating investigator (if applicable).  
 
The amendments to the CIP and the subject’s Informed Consent will be notified to, or approved by, the 
IRB/EC and regulatory authorities, if required. The version number and date of amendments will be 
documented. 
 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 35 of 41 
 
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 
15.0
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 subject needs an unplanned revision of the lead and/or extension during the IPG replacement 
 
The device /  therapy fails to perform as intended 
 
Occurrence of USADE which cannot be prevented in future cases 
 
Sponsor’s decision 
 
Recommendation from DSMB to Steering committee and Sponsor 
 
Request from Regulatory bodies 
 
Request of Ethics Committee(s)  
 
Concern for subject safety and welfare 
 
Failure to secure subject Informed Consent prior to any investigational activity 
 
Repeated non-compliance with this CIP or the Clinical Trial Agreement 
 
Inability to successfully implement this CIP 
 
Violation of the current Declaration of Helsinki   
 
Violation of applicable national or local laws and regulations 
 
Falsification of data, or any other breach of ethics or scientific principles 
 
Loss of or unaccounted use of investigational device inventory 
 
 
The study will be terminated according to applicable regulations. 
 
The investigator may also discontinue participation in the clinical study with appropriate written notice to 
the Sponsor. 
 
Should either of these events occur, the investigator will return all documents to the sponsor; provide a 
written statement as to why the premature termination has taken place and notify the IRB/EC and/or the 
Competent Authority (if applicable). Follow-up for all enrolled subjects will be as per CIP requirements. 
 
A Principal Investigator, IRB/EC or regulatory authority may suspend or prematurely terminate 
participation in a clinical study at the investigational sites for which they are responsible.   
 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 36 of 41 
 
If suspicion of an unacceptable risk to subjects arises during the clinical study or when so instructed by 
the IRB/EC or regulatory authority, St. Jude Medical may suspend the clinical study as appropriate 
while the risk is assessed.  St. Jude Medical will terminate the clinical study if an unacceptable risk is 
confirmed.   
 
St. Jude Medical will consider terminating or suspending the participation of a particular investigational 
site or investigator in the clinical study if monitoring or auditing identifies serious or repeated deviations 
on the part of an investigator.   
 
If suspension or premature termination occurs, the terminating party will justify its decision in writing 
and promptly inform the other parties with whom they are in direct communication.  The Principal 
Investigator and St. Jude Medical will keep each other informed of any communication received from 
IRB/EC or regulatory authority.   
 
If for any reason St. Jude Medical suspends or prematurely terminates the study at an individual 
investigational site, St. Jude Medical will inform the responsible regulatory authority, as appropriate, 
and ensure that the IRB/EC are notified, either by the Principal Investigator or by St. Jude Medical.  If 
the suspension or premature termination was in the interest of safety, St. Jude Medical will inform all 
other Principal Investigators.   
 
If suspension or premature termination occurs, St. Jude Medical will remain responsible for providing 
resources to fulfill the obligations from the CIP and existing agreements for following up the subjects 
enrolled in the clinical study, and the Principal Investigator or authorized designee will promptly inform 
the enrolled subjects at his/her investigational site, if appropriate.   
 
 
15.2 
RESUMING THE STUDY AFTER TEMPORARY SUSPENSION 
When St. Jude Medical concludes an analysis of the reasons for the suspension, implements the 
necessary corrective actions, and decides to lift the temporary suspension, St. Jude Medical will inform 
the Principal Investigators, IRB/EC, or regulatory authority, where appropriate, of the rationale, 
providing them with the relevant data supporting this decision.   
 
Concurrence will be obtained before the clinical study resumes from the IRB/EC or regulatory authority 
where appropriate.   
 
If subjects have been informed of the suspension, the Principal Investigator or authorized designee will 
inform them of the reasons for resumption. 
 
15.3 
STUDY CONCLUSION 
The study will be concluded when: 
 
All sites are closed AND 
 
The Final report generated by St. Jude Medical has been provided to sites or St. Jude Medical 
has provided formal documentation of study closure 
 
 
PUBLICATION POLICY 
16.0
The results of the clinical study will be submitted, whether positive or negative for publication.  
 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 37 of 41 
 
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  
17.0
Anderson VC, Burchiel KJ, Hogarth P, Favre J, Hammerstad JP. Pallidal vs subthalamic nucleus deep 
brain stimulation in Parkinson disease. Arch Neurol. 2005 Apr;62(4):554-60. 
 
Aström M, Tripoliti E, Hariz MI, Zrinzo LU, Martinez-Torres I, Limousin P, Wårdell K.; Patient-specific 
model-based investigation of speech intelligibility and movement during deep brain stimulation., 
Stereotact Funct Neurosurg. 2010;88(4):224-33. Epub 2010 May 12. 
 
Cantiniaux S, Vaugoyeau M, Robert D, Horrelou-Pitek C, Mancini J, Witjas T, Azulay JP., Comparative 
analysis of gait and speech in Parkinson's disease: hypokinetic or dysrhythmic disorders?, J Neurol 
Neurosurg Psychiatry. 2010 Feb;81(2):177-84. Epub 2009 Sep 30 
 
Castelli L, Lanotte M, Zibetti M, Caglio M, Rizzi L, Ducati A, Bergamasco B, Lopiano L., Apathy and 
verbal fluency in STN-stimulated PD patients. An observational follow-up study., J Neurol. 2007 
Sep;254(9):1238-43. Epub 2007 Apr 11. 
 
Cheung CT and Tagliati M. Deep Brain Stimulation: Can We Do It Better? Clin Neurophysiol 2010; 121: 
1979-1980. 
 
Daniels C, Krack P, Volkmann J, Pinsker MO, Krause M, Tronnier V, Kloss M, Schnitzler A, Wojtecki L, 
Bötzel K, Danek A, Hilker R, Sturm V, Kupsch A, Karner E, Deuschl G, Witt K.; Risk factors for 
executive dysfunction after subthalamic nucleus stimulation in Parkinson's disease., Mov Disord. 2010 
Aug 15;25(11):1583-9. 
 
Deuschl G, Schade-Brittinger C, Krack P, Volkmann J, Schafer H, Botzel K, et al. A randomized trial of 
deep-brain stimulation for Parkinson's disease. N Engl J Med. 2006 Aug 31;355(9):896-908. 
 
Follett KA. Comparison of pallidal and subthalamic deep brain stimulation for the treatment of levodopa-
induced dyskinesias. Neurosurg Focus. 2004 Jul 15;17(1):E3. 
 
Krack P, Batir A, Van Blercom N, Chabardes S, Fraix V, Ardouin C, Koudsie A, Limousin PD, 
Benazzouz A, LeBas JF, Benabid AL, Pollak P.; Five-year follow-up of bilateral stimulation of the 
subthalamic nucleus in advanced Parkinson's disease; N Engl J Med. 2003 Nov 13;349(20):1925-34 
 
Lang AE, Houeto JL, Krack P, Kubu C, Lyons KE, Moro E, et al. Deep brain stimulation: preoperative 
issues. Mov Disord. 2006 Jun;21 Suppl 14:S171-96. 
 
Lang AE, Widner H. Deep brain stimulation for Parkinson's disease: patient selection and evaluation. 
Mov Disord. 2002;17 Suppl 3:S94-101. 

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Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 38 of 41 
 
 
Lempka SF, Johnson MD, Miocinovic S, Vitek JL and McIntyre C. Current-controlled Deep Brain 
Stimulation Reduces In-Vivo Voltage Fluctuations Observed During Voltage-Controlled Stimulation. Clin 
Neurophysiol. 2010; 121: 2128-33. 
 
Okun MS, Fernandez HH, Wu SS, Kirsch-Darrow L, Bowers D, Bova F, et al. Cognition and mood in 
Parkinson's disease in subthalamic nucleus versus globus pallidus interna deep brain stimulation: the 
COMPARE trial. Ann Neurol. 2009 May;65(5):586-95. 
 
Okun MS, Fernandez HH, Pedraza O, Misra M, Lyons KE, Pahwa R, et al. Development and initial 
validation of a screening tool for Parkinson disease surgical candidates. Neurology. 2004 Jul 
13;63(1):161-3. 
 
Tripoliti E, Zrinzo L, Martinez-Torres I, Tisch S, Frost E, Borrell E, Hariz MI, Limousin P., Effects of 
contact location and voltage amplitude on speech and movement in bilateral subthalamic nucleus deep 
brain stimulation., Mov Disord. 2008 Dec 15;23(16):2377-83. 
 
Törnqvist AL, Schalén L, Rehncrona S., Effects of different electrical parameter settings on the 
intelligibility of speech in patients with Parkinson's disease treated with subthalamic deep brain 
stimulation., Mov Disord. 2005 Apr;20(4):416-23. 
 
Woods SP, Fields JA, Tröster AI., Neuropsychological sequelae of subthalamic nucleus deep brain 
stimulation in Parkinson's disease: a critical review., Neuropsychol Rev. 2002 Jun;12(2):111-26. 
Review. 
 
Williams A, Gill S, Varma T, Jenkinson C, Quinn N, Mitchell R, et al. Deep brain stimulation plus best 
medical therapy versus best medical therapy alone for advanced Parkinson's disease (PD SURG trial): 
a randomised, open-label trial. Lancet Neurol.  Jun;9(6):581-91.  
 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 39 of 41 
 
APPENDIX A: ABBREVIATIONS 
 
Select or add abbreviations used 
Abbreviation 
Term 
ADE 
AE 
ANZ 
ASADE 
CA 
CCI 
CEC 
CIP 
CRF 
CPRB 
DD 
DMP 
DSMB 
EC 
ECG 
eCRF 
EDC 
EMEA 
GP 
IB 
ICMJE 
IRB 
ISB 
ISO 
MMSE 
MP 
NA 
PD 
PI 
POA 
RDC 
SADE 
SAE 
SC  
SJM 
USADE 
WMA 
Adverse Device Effect 
Adverse Event 
Australia – New Zealand 
Anticipated Serious Adverse Device Effect 
Competent Authority 
Clinical Coordination Investigator 
Clinical Events Committee 
Clinical Investigational Plan 
Case Report Form 
Clinical Project Review Board 
Device Deficiency 
Data Management Plan 
Data Safety Monitoring Board  
Ethics Committee 
Electrocardiogram 
Electronic Case Report Form 
Electronic Data Capture 
Europe, Middle East, Africa 
General Practitioner 
Investigator Brochure 
International Committee of Medical Journal Editors 
Institutional Review Board 
Investigator Site Binder 
International Organization for Standardization 
Mini-mental state examination 
Monitoring Plan 
Not Applicable 
Parkinson’s Disease 
Principal Investigator 
Power of Attorney 
Remote Data Capture 
Serious Adverse Device Effect 
Serious Adverse Event 
Steering Committee 
St. Jude Medical 
Unanticipated Serious Adverse Device Effect 
World Medical Association 
 
 
 
 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 40 of 41 
 
APPENDIX B: CIP REVISION HISTORY 
 
 
 
 
 
 
 
 
 
 

Study Document No: SJM-CIP-10135 Ver. [B] 
Study Name: PREFERENCE-H 
Clinical Investigational Plan  
 
Template: 86357  Rev. A                                                                                                                       Page 41 of 41 
 
Appendix C: DECLARATION OF HELSINKI 
The most current version of the document will be followed. 
Appendix D: DEVICE MANUAL 
A copy of the device manuals will be kept under a separate cover and is available upon request. 
 
 
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 informed consent will be kept under a separate cover and are available upon request. 
 
Appendix G: CASE REPORT FORMS 
The case report forms will be kept under a separate cover and are available upon request.