IPG Replacement Study (PREFERENCE-H)

Study Overview
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Brief Summary
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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 Brio™ constant current system. As electrodes will not be 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.

Official Title
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Prospective Evaluation Comparing the Effects of Constant Current Versus Constant Voltage in Deep Brain Stimulation Using Hybrid Systems

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: 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 Infinity™ or a St Jude Medical Brio™ DBS system for the IPG replacement; Subject is unable to attend the study visits.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system<br>Subjects will be implanted with SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system | Device: SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system<br>* Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects who indicate preference on constant current over constant voltage at the 3 Month follow-up visit. | The proportion of subjects who indicate preference on constant current over constant voltage at the 3 Month follow-up visit will be assessed. | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of safety events related to battery replacement procedures for hybrid systems | The event rate will be summarized as (1) number of 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 12 months 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 months after IPG replacement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SJM Infinity™, SJM Brio™, Implantable pulse generator (IPG) replacement, SJM-CIP-10135, Deep brain stimulation (DBS)