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Clinical Trials in the USA / NCT05701280
Active, not recruiting Not applicable

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
2026-10-05

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
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

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 (9)

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

Other trials for the same condition

SIMPLAAFY Clinical Trial Active, not recruiting
Traumatic Brain Injury and Stroke Long Term Outcome Recruiting
Ankle Robotics After Stroke Recruiting
Elite AF IDE Trial (Elite AF) Recruiting
Treatment of Acute Ischemic Stroke (ReMEDy2 Trial) 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