Rehab With Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study
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.
Description
The RESTORE Stroke Study combines two phases of study under one protocol (pilot/pivotal). The first phase has a sample size of 40 subjects. The second phase has an estimated sample size of 162 subjects which may be adjusted based on analysis of the first phase. Each subject will be implanted with the DBS system, undergo DBS program optimization, and be randomized to test treatment (Tt) or active-control treatment (Ct). After randomization, all subjects will participate in a five-month outpatient rehabilitation therapy program. After five months of blinded randomized testing, subjects assigned…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DeviceDeep Brain Stimulation
Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus motor rehabilitation to improve upper-extremity function.
- OtherRehabilitation
Motor rehabilitation to improve upper-extremity function.
Locations (10)
- Barrow Neurological Institute (BNI)Phoenix, Arizona
- Mayo Clinic FloridaJacksonville, Florida
- Johns Hopkins School of MedicineBaltimore, Maryland
- Massachusetts General HospitalBoston, Massachusetts
- Mayo ClinicRochester, Minnesota
- NYU Langone HealthNew York, New York