Pilot/Pivotal Study of DBS+Rehab After Stroke

Last updated: January 20, 2026
Sponsor: Enspire DBS Therapy, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cardiac Ischemia

Cerebral Ischemia

Stroke

Treatment

Deep Brain Stimulation

Rehabilitation

Clinical Study ID

NCT05701280
REDD 0084
  • Ages > 21
  • All Genders

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 Criteria

Inclusion

Key Inclusion Criteria:

  • Ischemic stroke, with an initial incident occurring between 12 months to 6 yearsbefore implant, resulting in residual upper extremity hemiparesis.

Exclusion

Key Exclusion Criteria:

  • Previous or subsequent cerebrovascular events resulting in residual upper extremityimpairment

  • Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus

Study Design

Total Participants: 202
Treatment Group(s): 2
Primary Treatment: Deep Brain Stimulation
Phase:
Study Start date:
February 03, 2023
Estimated Completion Date:
June 30, 2030

Study 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.

Connect with a study center

  • Barrow Neurological Institute (BNI)

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Barrow Neurological Institute (BNI)

    Phoenix 5308655, Arizona 5551752 85013
    United States

    Active - Recruiting

  • Mayo Clinic Florida

    Jacksonville 4160021, Florida 4155751 32224
    United States

    Active - Recruiting

  • Johns Hopkins School of Medicine

    Baltimore 4347778, Maryland 4361885 21218
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55906
    United States

    Site Not Available

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55906
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • NYU Langone Health

    New York 5128581, New York 5128638 10016
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Active - Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence 5224151, Rhode Island 5224323 02903
    United States

    Active - Recruiting

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina (MUSC)

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Terminated

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