Pilot/Pivotal Study of DBS+Rehab After Stroke
RESTORE
Rehab With Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study
1 other identifier
interventional
202
1 country
10
Brief Summary
The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Feb 2023
Longer than P75 for not_applicable stroke
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2023
CompletedFirst Posted
Study publicly available on registry
January 27, 2023
CompletedStudy Start
First participant enrolled
February 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
January 21, 2026
January 1, 2026
3.3 years
January 9, 2023
January 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
The change in FMA-UE is significantly greater for subjects who receive Test treatment (Tt) than Control treatment (Ct).
Week-12 to Week-32
Secondary Outcomes (1)
Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
Week-12 to Week-32
Other Outcomes (1)
Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
Week-32, Week-40 and Week 52
Study Arms (2)
DBS+Rehab
EXPERIMENTALActive-DBS combined with motor rehabilitation
Rehab
ACTIVE COMPARATORControl-DBS combined with motor rehabilitation
Interventions
Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus motor rehabilitation to improve upper-extremity function.
Eligibility Criteria
You may qualify if:
- Ischemic stroke, with an initial incident occurring between 12 months to 6 years before implant, resulting in residual upper extremity hemiparesis.
You may not qualify if:
- Previous or subsequent cerebrovascular events resulting in residual upper extremity impairment
- Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Barrow Neurological Institute (BNI)
Phoenix, Arizona, 85013, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, 21218, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Mayo Clinic
Rochester, Minnesota, 55906, United States
NYU Langone Health
New York, New York, 10016, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants, Care Providers (Therapists), Investigators, and Outcome Assessors do not know to which group the participants are randomized.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2023
First Posted
January 27, 2023
Study Start
February 3, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2030
Last Updated
January 21, 2026
Record last verified: 2026-01