Status:
UNKNOWN
Automated Deep Brain Stimulation Programming Using Functional Mapping
Lead Sponsor:
Great Lakes NeuroTechnologies Inc.
Collaborating Sponsors:
Wake Forest University Health Sciences
Ohio State University
Conditions:
Parkinson Disease
Eligibility:
All Genders
35-80 years
Phase:
NA
Brief Summary
Participants will undergo DBS programming guided by the DBS-Expert system and by a clinician per standard care.
Eligibility Criteria
Inclusion
- The ability to provide informed consent
- Clinical diagnosis of idiopathic Parkinson's disease (PD)
- Implanted deep brain stimulation (DBS) system for tremor and/or bradykinesia
Exclusion
- Significant medical or psychiatric illness or dementia as evidenced by a score less than 26 on the Montreal Cognitive Assessment
- Not capable of functioning independently
- Individuals so symptomatic as to compromise safety
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02765282
Start Date
October 1 2018
End Date
June 1 2020
Last Update
June 27 2019
Active Locations (3)
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1
Atrium Health
Charlotte, North Carolina, United States, 28207
2
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
3
Ohio State University
Columbus, Ohio, United States, 43210