RecruitingNot ApplicableNCT05701280

Pilot/Pivotal Study of DBS+Rehab After Stroke

Rehab With Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study

Sponsor

Enspire DBS Therapy, Inc.

Enrollment

202 participants

Start Date

Feb 3, 2023

Study Type

INTERVENTIONAL

Conditions

Stroke Upper Extremity Paresis

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

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Deep Brain Stimulation and Rehabilitation for people with stroke and upper extremity paresis. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 21 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

NYU Langone Health

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

View Full Details on ClinicalTrials.gov

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NCT05701280

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