Status:
ACTIVE_NOT_RECRUITING
Closed Loop DBS Implanted RC+S Study
Lead Sponsor:
Dennis Turner, M.D.
Collaborating Sponsors:
National Institutes of Health (NIH)
Duke University
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study involves patients who are already planning to have deep brain stimulation (DBS) surgery to treat the symptoms of severe Parkinson's Disease (PD). The study has two goals: 1. to evaluate th...
Detailed Description
The purpose of this study is a small, first in man, clinical feasibility trial for patients with severe Parkinson's Disease (PD), who are already clinically eligible for deep brain stimulation (DBS) w...
Eligibility Criteria
Inclusion
- able to give informed consent
- diagnosed with Parkinson's Disease and is considered a surgical candidate for DBS
- has medication-related side effects from levodopa (i.e., dyskinesias, on-off fluctuations)
- has off-on improvement with levodopa of at least 30%
- is available for follow-up visits for length of study
Exclusion
- is not safe surgical candidate for DBS
- has severe neurological injury or disease other than Parkinson's Disease
- has condition requiring repeated MRI scans
- has untreated, clinically significant depression
- has an electrical or electromagnetic implant
- had a prior thalamotomy or surgical ablation procedure
- has dementia interfering with ability to comply with study requirements or give informed consent
- abuses drugs or alcohol
- has a history of seizures
- has any metallic implants
- is pregnant
Key Trial Info
Start Date :
July 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2027
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03815656
Start Date
July 10 2019
End Date
January 1 2027
Last Update
December 17 2024
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710