Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced, levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication.

Detailed Description
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The study is multi-center, prospective, double-blind, randomized (3:1) controlled trial. GUIDE XT may be used for planning of programming as needed.

Official Title
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Implantable Neurostimulator for the Treatment of Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: Deep Brain Stimulation


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Diagnosis of bilateral idiopathic PD (H&Y ≥ 2) with a duration of PD ≥ 5 years. Persistent disabling Parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling off periods) despite optimal medical therapy. Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed. Key Exclusion Criteria: Any intracranial abnormality or medical condition that would contraindicate DBS surgery. Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol Any other active implanted devices including neurostimulators and /or drug delivery pumps Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure. Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints. A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Medium continuous dose of stimulation<br>Subjects in this arm will receive stimulation settings at a medium continuous dose of Deep Brain stimulation that may have been effective in previous DBS patients. | Device: Deep Brain Stimulation<br>* The Vercise™ DBS system will be implanted in subjects in both study arms. Stimulation parameters will vary depending on the study arm assignment. All subjects will receive therapeutic settings at the end of the blinded period.<br>* Other names: Vercise™ Deep Brain Stimulation (DBS) system.;|
| Sham Comparator: Low intermittent dose of stimulation<br>Subjects in this arm will receive stimulation settings at a lower intermittent dose of Deep Brain stimulation which is less likely to be effective. | Device: Deep Brain Stimulation<br>* The Vercise™ DBS system will be implanted in subjects in both study arms. Stimulation parameters will vary depending on the study arm assignment. All subjects will receive therapeutic settings at the end of the blinded period.<br>* Other names: Vercise™ Deep Brain Stimulation (DBS) system.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ON Time as Measured by Parkinson's Disease Diary | Difference in the mean change from baseline to 12 weeks post-randomization between the active and control groups in the ON time as measured by Parkinson's diary. Positive indicates improvement | From baseline to 12 weeks post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoints | Change in Unified Parkinson's Disease Rating Scale (UDPRS) Part III (stim on/meds off) from baseline to 12 weeks post randomization. Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state. | From baseline to 12 weeks post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrepid, Vercise, PD, DBS, Boston Scientific