Combining Deep Brain Stimulation with Rehabilitation for Stroke Recovery
Rehab With Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study
This study is testing if combining deep brain stimulation with rehab can help people who have arm weakness after a stroke get better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 202 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Enspire DBS Therapy, Inc. Industry-sponsored |
| Locations | 10 sites (Phoenix, Arizona and 9 other locations) |
| Trial ID | NCT05701280 on ClinicalTrials.gov |
What this trial studies
The RESTORE Stroke Study evaluates the safety and effectiveness of combining deep brain stimulation (DBS) with rehabilitation therapy for patients suffering from arm weakness and reduced function after a stroke. This study consists of two phases: a pilot phase with 40 subjects and a pivotal phase with an estimated 162 subjects, where participants will receive DBS implants and undergo a five-month outpatient rehabilitation program. Subjects will be randomized to either the treatment group or an active-control group, with the latter receiving the treatment after an initial five-month period. The goal is to assess improvements in upper extremity function post-stroke.
Who should consider this trial
Good fit: Ideal candidates are individuals who have experienced an ischemic stroke resulting in upper extremity hemiparesis, occurring between 12 months to 6 years prior to the study.
Not a fit: Patients with previous cerebrovascular events or significant brain lesions affecting critical areas like the brainstem, cerebellum, or thalamus may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery and functional independence for stroke patients with upper extremity paresis.
How similar studies have performed: While the combination of DBS and rehabilitation is a novel approach, similar studies have shown promise in enhancing recovery in neurological conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Phoenix, Arizona and 9 other locations
- Barrow Neurological Institute (BNI) — Phoenix, Arizona, United States (Recruiting)
- Mayo Clinic Florida — Jacksonville, Florida, United States (Recruiting)
- Johns Hopkins School of Medicine — Baltimore, Maryland, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
- Rhode Island Hospital — Providence, Rhode Island, United States (Recruiting)
- Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States (Terminated)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.