Vercise Implantable Stimulator for Treating Parkinson's Disease

Study Overview
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Brief Summary
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The purpose of this study is to document patient outcomes, including effectiveness, safety, and health economic data, for the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment of moderate to severe idiopathic Parkinson's Disease (PD).

Detailed Description
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This is a multi-center, prospective, open label, non-randomized study which will use a within-patient control (each patient serves as his/her own control) to document patient outcomes, including effectiveness, safety, and health economic data for the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment of moderate to severe idiopathic Parkinson's Disease (PD).

Official Title
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VANTAGE STUDY Vercise™ Implantable Stimulator for Treating Parkinson's Disease

Conditions
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Idiopathic 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 with the presence of at least 2 of the following: resting tremor, rigidity, or bradykinesia. Duration of bilateral idiopathic PD of more than five years. Stable medications UPDRS subset III score of ≥30 without medication. Lack of dementia or depression. Must improve with antiparkinsonian medication, but have some motor complications that are not well controlled by medications. Must be an appropriate candidate for the surgical procedures required for bilateral STN DBS. Is willing and able to comply with all visits and study related procedures Patient understands 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. Any finding in neuropsychological screening assessments that would contraindicate DBS surgery, including dementia. Any significant psychiatric problems, including unrelated clinically significant depression. Any current drug or alcohol abuse. Any history of recurrent or unprovoked seizures. Frequent falls while receiving good medication therapy without dyskinesias (on-state). Any prior movement disorder treatments that involved intracranial surgery or device implantation. Any other active implanted device. Any previous brain surgery that would interfere with the placement of the leads or the functioning of the device. A history of neurostimulation intolerance in any area of the body. A condition requiring or likely to require the use of magnetic resonance imaging (MRI) or diathermy. Currently on any anticoagulant medications that can not be discontinued during perioperative period. Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months. Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators. A female that 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: 21 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
Intervention Model: Single Group Assignment
Interventional Model Description: Boston Scientific Vercise Deep Brain Stimulation system will be implanted and each patient will serve as its own control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep Brain Stimulation<br>Rechargeable Deep Brain Stimulation System | Device: Deep Brain Stimulation<br>* Rechargeable Deep Brain Stimulation System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in UPDRS III Score From Baseline in the Meds Off Condition (no Medications) to 26 Weeks Post First Lead Implantation in the Stim on/Meds Off Condition (Stimulation on and no Medications). | Unified Parkinson's Disease Rating Scale Part III (UPDRS III) is the motor sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate overall motor disability, including the classic symptoms of Parkinson's Disease. This section has 14 items. Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108 with lower scores representing better results. | 26 weeks post first lead implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off. | Unified Parkinson's Disease Rating Scale Part III (UPDRS III) is the motor sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate overall motor disability, including the classic symptoms of Parkinson's Disease. This section has 14 items. Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108 with lower scores representing better results. | 12 and 52 weeks post first lead implantation | 
| Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off. | Unified Parkinson's Disease Rating Scale Part II (UPDRS II) is a sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate Activities of Daily Living. This section contains 13 items. Each item is scored on a scale from 0 (normal) to 4 (disabled), with the total score for the 13 items ranging from 0 to 52. | 12, 26 and 52 weeks post first lead implantation | 
| Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation | All parkinsonian medications will be converted to Levodopa dose equivalents (LED) and baseline dose will be compared with dose taken at 12, 26 and 52 weeks post implantation | 12, 26 and 52 weeks post first lead implantation | 
| Mean Change in the Number of Waking Hours Per Day With Good Symptom Control and no Troublesome Dyskinesia From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation. | Subjects will complete a 3-day motor diary prior to study visits. At one-hour increments (during waking hours), patients will record on, on with troublesome dyskinesia, off, and asleep times for three consecutive days. | 12, 26 and 52 weeks post first lead implantation | 
| Mean Percent Change in Quality of Life Scale Scores: Parkinson's Disease Questionnaire (PDQ-39) From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on. | The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item questionnaire designed to measure the specific impact of PD on quality of life. The questions measure the impact on health-related quality of life along 8 dimensions: mobility activities of daily living emotional well-being stigma social support cognitions communication bodily discomfort. Dimension scores range from 0 to 100, with 0 representing perfect health for the measure and 100 representing worst health for the measure. | 12, 26 and 52 weeks post first lead implantation | 
| Mean Percent Change in Quality of Life Scale Scores: Modified Schwab and England (SE) Scores From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on | The purpose of the Schwab and England (SE) (13) single-item scale is to quantify a PD patients' ability to perform activities of daily living. The single item is based on a percentage rating with scores in 10% increments. Scores range from 0% (completely bed-ridden) to 100% (completely independent). | 12, 26 and 52 weeks post first lead implantation | 
| Percentage of Participants With Improved, No Change or Worsened Global Impression of Change (GIC) as Compared to Baseline, Evaluated by the Neurologist. | Global Impression of Change (GIC) is a comparison to baseline and will be evaluated by rating the global impression of change using a seven-point scale: (very much improved to marked worsening). This assessment was completed by the neurologist. | 52 weeks post first lead implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Brain Stimulation, Parkinson's Disease