Study to Characterize Acute and Chronic Directional Aspects of Deep Brain Stimulation
Not Applicable
Completed
- Conditions
- Parkinson Disease
- Interventions
- Device: BSC Deep Brain Stimulation System with Directional Lead
- Registration Number
- NCT02835274
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The primary objective is to characterize the programming effects of Boston Scientific Vercise™ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of Parkinson's disease in acute and chronic settings.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- Diagnosis of bilateral idiopathic PD with the presence of rigidity and at least one (1) of the following: resting tremor or bradykinesia.
- UPDRS III score of >25 in the meds OFF condition
- Medication must improve PD symptoms by ≥30%, as measured by UPDRS subset III score
Key
Exclusion Criteria
- Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator
- Any current drug or alcohol abuse as determined by the investigator
- Any history of recurrent or unprovoked seizures
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Unrestricted mode followed by ring mode BSC Deep Brain Stimulation System with Directional Lead Unrestricted Mode stimulation followed by omni-directional stimulation Ring mode followed by Unrestricted mode BSC Deep Brain Stimulation System with Directional Lead omni-directional stimulation followed by unrestricted Mode stimulation
- Primary Outcome Measures
Name Time Method Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase Up to 12 months post-implant Mean change in Unified Parkinson's Disease Rating Scale (UPDRS) scores - motor section (Part III) at end of randomized phase in meds ON condition
Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
CHU Grenoble - Hopital Michallon
🇫🇷Grenoble, France
Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, Germany
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
CHU Grenoble - Hopital Michallon🇫🇷Grenoble, France