Pilot/Pivotal Study of DBS+Rehab After Stroke
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Enspire DBS Therapy, Inc.
- Study ID
- NCT05701280
- Status
- Recruiting
Conditions
- Stroke
- Upper Extremity Paresis
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Deep Brain Stimulation — DEVICEDeep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus motor rehabilitation to improve upper-extremity function.
- Rehabilitation — OTHERMotor rehabilitation to improve upper-extremity function.
Study Details
The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.
Key Dates
- Start date
- Feb 3, 2023
- Status verified
- Jan 2026
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2030
Study Design
- Enrollment
- 202 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: DBS+RehabActive-DBS combined with motor rehabilitation
- Active Comparator: RehabControl-DBS combined with motor rehabilitation
Primary Outcome Measure
Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE) [ Time Frame: Week-12 to Week-32 ]
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Barrow Neurological Institute (BNI) | Phoenix | Arizona | 85013 | Francisco Ponce, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | Sanjeet Grewal, MD (PRINCIPAL_INVESTIGATOR) |
| Johns Hopkins School of Medicine | Baltimore | Maryland | 21218 | William Anderson, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | R. Mark Richardson, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic | Rochester | Minnesota | 55906 | Rushna Ali, MD (PRINCIPAL_INVESTIGATOR) |
| NYU Langone Health | New York | New York | 10016 | Alon Mogilner, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Andre Machado, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | Chengyuan Wu, MD (PRINCIPAL_INVESTIGATOR) |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | Wael Asaad, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | - |
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