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Pilot/Pivotal Study of DBS+Rehab After Stroke
Sponsor: Enspire DBS Therapy, Inc.
Summary
The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.
Official title: Rehab With Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
202
Start Date
2023-02-03
Completion Date
2030-06
Last Updated
2026-01-21
Healthy Volunteers
No
Conditions
Interventions
Deep Brain Stimulation
Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus motor rehabilitation to improve upper-extremity function.
Rehabilitation
Motor rehabilitation to improve upper-extremity function.
Locations (10)
Barrow Neurological Institute (BNI)
Phoenix, Arizona, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
NYU Langone Health
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States