Recruiting

DBS & Rehab

Sponsor:

Enspire DBS Therapy, Inc.

Code:

NCT05701280

Conditions

Stroke

Upper Extremity Paresis

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Deep Brain Stimulation

Rehabilitation

Study Details

Brief summary:

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

Conditions

Stroke

Upper Extremity Paresis

Study ID

NCT05701280

Start date

Feb 3, 2023

Status verified date

Jan, 2026

Completion date

Jun, 2030

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

202 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DBS+Rehab

Active-DBS combined with motor rehabilitation

active comparator: Rehab

Control-DBS combined with motor rehabilitation

Interventions

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.

Primary outcome measure

  • Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE) [ Time Frame: Week-12 to Week-32 ]

Central Contacts and Locations

Locations

Barrow Neurological Institute (BNI)

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Markey Olson, PhD

602-406-6055neuromodulationresearch@commonspirit.org

Principal Investigator:

Francisco Ponce, MD

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Amber Patchell

904-953-4711Patchell.Amber@mayo.edu

Principal Investigator:

Sanjeet Grewal, MD

Johns Hopkins School of Medicine

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Robert Nickl, PhD

410-955-1347rnickl1@jh.edu

Jessica Wollet

667-306-8141jwollet1@jhu.edu

Principal Investigator:

William Anderson, MD, PhD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Erin Donahue, PhD

617-643-3732ekdonahue@mgh.harvard.edu

Principal Investigator:

R. Mark Richardson, MD, PhD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55906

Contacts

Olyvia Heaser

507-538-6563Heaser.Olyvia@mayo.edu

Principal Investigator:

Rushna Ali, MD

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Cathryn Lapierre

6465012762cathryn.lapierre@nyulangone.org

Ava Paul

212-263-2314Ava.Paul@nyulangone.org

Principal Investigator:

Alon Mogilner, MD, PhD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Karen Stevenson

216-445-0926STEVENK12@ccf.org

Principal Investigator:

Andre Machado, MD, PhD

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Neurosurgery Research Department

215-503-4852neurosurgeryresearch@jefferson.edu

Principal Investigator:

Chengyuan Wu, MD

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Amanda Hasbrouck

401-444-6682ahasbrouck@lifespan.org

Principal Investigator:

Wael Asaad, MD, PhD

More Information

Sponsor

Enspire DBS Therapy, Inc.

Last update posted

Jul 20, 2026

Last verified

Jan, 2026

Keywords

  • Ischemic Stroke
  • Deep Brain Stimulation
  • DBS
  • Physical Therapy
  • Rehabilitation
  • Brain Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Enspire DBS Therapy, Inc. on 2026-07-20.