Pilot/Pivotal Study of DBS+Rehab After Stroke
Purpose
The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.
Conditions
- Stroke
- Upper Extremity Paresis
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Ischemic stroke, with an initial incident occurring between 12 months to 6 years before implant, resulting in residual upper extremity hemiparesis.
Exclusion Criteria
- Previous or subsequent cerebrovascular events resulting in residual upper extremity impairment - Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Double-blinded, randomized, parallel study with partial crossover.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Participants, Care Providers (Therapists), Investigators, and Outcome Assessors do not know to which group the participants are randomized.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental DBS+Rehab |
Active-DBS combined with motor rehabilitation |
|
|
Active Comparator Rehab |
Control-DBS combined with motor rehabilitation |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Enspire DBS Therapy, Inc.
Study Contact
Detailed 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 to active-control treatment (Ct) will cross over to receive test treatment (Tt) and participate in a second five-month therapy program.