Status:
TERMINATED
Temporally Optimized Patterned Stimulation (TOPS®) Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
Lead Sponsor:
Deep Brain Innovations LLC
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study will test newly developed stimulation settings called Temporally Optimized Patterned Stimulation or TOPS, which can be used with an already implanted deep brain stimulation system. The purp...
Eligibility Criteria
Inclusion
- Key
- Diagnosed with Parkinson's disease
- Implanted with unilateral or bilateral subthalamic DBS System to treat Parkinson's disease at least 6 months prior to the study date
- Responds to DBS by having demonstrated a minimum improvement in motor score
- Key
Exclusion
- Score of \<24 on the Mini Mental Status Exam
- Abuses drugs or alcohol
- Pregnant
- History of significant cardiovascular, pulmonary, musculoskeletal, metabolic, or other neurological disorders (i.e. epilepsy, stroke)
- Prisoners, employees that report to investigators
Key Trial Info
Start Date :
July 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04390867
Start Date
July 27 2020
End Date
February 8 2022
Last Update
June 27 2022
Active Locations (3)
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1
University of Florida
Gainesville, Florida, United States, 32608
2
Northwestern University
Chicago, Illinois, United States, 60611
3
Duke University
Durham, North Carolina, United States, 27705