Directional Lead: Investigation of Rotational Current Steering, Ease of Use of Clinical Effects Map, and Therapeutic Outcomes of Deep Brain Stimulation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
- Locations
- 3
- Primary Endpoint
- Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
Ring mode followed by Unrestricted mode
omni-directional stimulation followed by unrestricted Mode stimulation
Intervention: BSC Deep Brain Stimulation System with Directional Lead (Device)
Unrestricted mode followed by ring mode
Unrestricted Mode stimulation followed by omni-directional stimulation
Intervention: BSC Deep Brain Stimulation System with Directional Lead (Device)
Outcomes
Primary Outcomes
Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase
Time Frame: 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 Outcomes
No secondary outcomes reported