Pilot/Pivotal Study of DBS+Rehab After Stroke

NCT05701280 · tracked via the Priya Life Science USA tracker

Sponsor

Enspire DBS Therapy, Inc.

Phase

Not applicable

Started

2023-02-03

Last updated

2026-07-20

Condition(s) studied

StrokeUpper Extremity Paresis

Investigational drug(s) / intervention(s)

Deep Brain StimulationRehabilitation

Deep Brain Stimulation: Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus motor rehabilitation to improve upper-extremity function.

Rehabilitation: Motor rehabilitation to improve upper-extremity function.

Study summary

The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.

Eligibility

Sex

ALL

Min age

21 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE) — Week-12 to Week-32
The change in FMA-UE is significantly greater for subjects who receive Test treatment (Tt) than Control treatment (Ct).

Trial sites (10)

Facility	City	Region	Status
Barrow Neurological Institute (BNI)	Phoenix	Arizona	Recruiting
Mayo Clinic Florida	Jacksonville	Florida	Recruiting
Johns Hopkins School of Medicine	Baltimore	Maryland	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
Mayo Clinic	Rochester	Minnesota	Recruiting
NYU Langone Health	New York	New York	Recruiting
Cleveland Clinic	Cleveland	Ohio	Recruiting
Thomas Jefferson University	Philadelphia	Pennsylvania	Recruiting
Rhode Island Hospital	Providence	Rhode Island	Recruiting
Medical University of South Carolina (MUSC)	Charleston	South Carolina	Terminated

Other trials for the same condition

Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation Recruiting

Traumatic Brain Injury and Stroke Long Term Outcome Recruiting

SIMPLAAFY Clinical Trial Active, not recruiting

CHAMPION-AF Clinical Trial Active, not recruiting

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05701280 on ClinicalTrials.gov ↗ ← All trials in the USA