Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation
About the study
The objective of this study is to evaluate the performance of novel DBS programming methods compared to traditional programming methods.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria:
- Implanted bilaterally in STN or GPi with a Vercise™ DBS system for Parkinson's disease, including directional leads, for at least four months and programming optimized according to standard of care with no changes to electrode configuration of primary settings for at least four weeks.
- Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
- Be at least 18 years of age.
- Device must have been implanted on label or must be on label by the time the subject gets enrolled.
EXCLUSION CRITERIA
Key Exclusion Criteria:
* Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Parkinson Disease
Age
18+
Phase
NA
Participants Needed
100
Est. Completion Date
Feb 28, 2026
Treatment Type
INTERVENTIONAL
Sponsor
Boston Scientific Corporation
ClinicalTrials.gov NCT Identifier
NCT03037398
Study Number
A4063
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