Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
NCT05701280

Pilot/Pivotal Study of DBS+Rehab After Stroke

Led by Enspire DBS Therapy, Inc. · Updated on 2026-01-21

202

Participants Needed

10

Research Sites

382 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Pilot/Pivotal Study of DBS+Rehab After Stroke

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ischemic stroke with initial incident occurring between 12 months to 6 years before implant
  • Residual upper extremity hemiparesis resulting from the stroke
Not Eligible

You will not qualify if you...

  • Previous or subsequent cerebrovascular events causing residual upper extremity impairment
  • Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

Barrow Neurological Institute (BNI)

Phoenix, Arizona, United States, 85013

Actively Recruiting

2

Mayo Clinic Florida

Jacksonville, Florida, United States, 32224

Actively Recruiting

3

Johns Hopkins School of Medicine

Baltimore, Maryland, United States, 21218

Actively Recruiting

4

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

5

Mayo Clinic

Rochester, Minnesota, United States, 55906

Actively Recruiting

6

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

7

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

8

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

9

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Actively Recruiting

10

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States, 29425

Terminated

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Pilot/Pivotal Study of DBS+Rehab After Stroke | DecenTrialz