Pilot/Pivotal Study of DBS+Rehab After Stroke

Last updated: May 8, 2025
Sponsor: Enspire DBS Therapy, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Rehabilitation

Deep Brain Stimulation

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: Rehabilitation
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

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55906
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

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