Temporally Optimized Patterned Stimulation (TOPS®) Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
NCT ID: NCT04390867
Last Updated: 2022-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
6 participants
INTERVENTIONAL
2020-07-27
2022-02-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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TOPS1 DBS
Participants receive TOPS1 for one week if it meets screening criteria, followed by one week each of TOPS2, TOPS3, and Standard in random order.
TOPS1 DBS
TOPS1 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
TOPS2 DBS
TOPS2 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
TOPS3 DBS
TOPS3 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
Standard DBS
Standard is the pattern of stimulation that is usually delivered clinically by a DBS system
TOPS2 DBS
Participants receive TOPS2 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS3, and Standard in random order.
TOPS1 DBS
TOPS1 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
TOPS2 DBS
TOPS2 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
TOPS3 DBS
TOPS3 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
Standard DBS
Standard is the pattern of stimulation that is usually delivered clinically by a DBS system
TOPS3 DBS
Participants receive TOPS3 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS2, and Standard in random order.
TOPS1 DBS
TOPS1 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
TOPS2 DBS
TOPS2 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
TOPS3 DBS
TOPS3 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
Standard DBS
Standard is the pattern of stimulation that is usually delivered clinically by a DBS system
Standard DBS
Participants receive Standard for one week, followed by one week each of TOPS1, TOPS2, and TOPS3 in random order.
TOPS1 DBS
TOPS1 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
TOPS2 DBS
TOPS2 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
TOPS3 DBS
TOPS3 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
Standard DBS
Standard is the pattern of stimulation that is usually delivered clinically by a DBS system
Interventions
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TOPS1 DBS
TOPS1 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
TOPS2 DBS
TOPS2 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
TOPS3 DBS
TOPS3 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system
Standard DBS
Standard is the pattern of stimulation that is usually delivered clinically by a DBS system
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Deep Brain Innovations LLC
INDUSTRY
Responsible Party
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Locations
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University of Florida
Gainesville, Florida, United States
Northwestern University
Chicago, Illinois, United States
Duke University
Durham, North Carolina, United States
Countries
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Other Identifiers
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0152
Identifier Type: -
Identifier Source: org_study_id
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