Home › Stroke › NCT05701280
Pilot/Pivotal Study of DBS+Rehab After Stroke
Recruiting
Rehab With Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study
Who can join
Ages 21 and older · All sexes
Full eligibility criteria
Key Inclusion Criteria: * Ischemic stroke, with an initial incident occurring between 12 months to 6 years before implant, resulting in residual upper extremity hemiparesis. Key Exclusion Criteria: * Previous or subsequent cerebrovascular events resulting in residual upper extremity impairment * Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus
About the study
The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.
What is being tested
- Deep Brain Stimulation (device)
- Rehabilitation (other)
Sponsor: Enspire DBS Therapy, Inc. · Participants: 202 · Started: Feb 3, 2023
Contact the study team
Official record on ClinicalTrials.gov — NCT05701280
Locations in the U.S.
| Arizona | Barrow Neurological Institute (BNI), Phoenix |
| Florida | Mayo Clinic Florida, Jacksonville |
| Maryland | Johns Hopkins School of Medicine, Baltimore |
| Massachusetts | Massachusetts General Hospital, Boston |
| Minnesota | Mayo Clinic, Rochester |
| New York | NYU Langone Health, New York |
| Ohio | Cleveland Clinic, Cleveland |
| Pennsylvania | Thomas Jefferson University, Philadelphia |
| Rhode Island | Rhode Island Hospital, Providence |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.