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
Inclusion Criteria:
- Implanted bilaterally in STN with a Vercise™ DBS system for Parkinson's disease 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.
EXCLUSION CRITERIA
Exclusion Criteria:
- Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.
- Device must be implanted on label.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Parkinson Disease
Age (in years)
18+
Phase
Not Applicable
Participants needed
60
Est. Completion Date
Dec 31, 2024
Treatment type
Interventional
Sponsor
Boston Scientific Corporation
ClinicalTrials.gov identifier
NCT03037398
Study number
A4063
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