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Could a brain pacemaker help stroke survivors move again?

NCT ID NCT05701280

Disease control Sponsor: Enspire DBS Therapy, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This study tests whether deep brain stimulation (DBS) combined with physical therapy can improve arm weakness in people who had a stroke 1 to 6 years ago. About 202 participants will receive either DBS plus rehab or rehab alone. The goal is to see if the treatment safely restores arm movement and function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Deep brain stimulation (DBS) device
What this could lead to
If successful, this could offer a new way to improve arm movement and daily function for people with long-term weakness after a stroke.
What could go wrong
This is an early pivotal study with 202 participants, so results may not apply to everyone. DBS surgery carries risks like infection or bleeding, and the treatment may not work for all.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 202 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ischemic stroke Paresis stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stroke Upper extremity paresis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    9 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Barrow Neurological Institute (BNI)

    RECRUITING

    Phoenix, Arizona, 85013, United States

    Contact Email: •••••@•••••

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Johns Hopkins School of Medicine

    RECRUITING

    Baltimore, Maryland, 21218, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55906, United States

  • Mayo Clinic Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Medical University of South Carolina (MUSC)

    TERMINATED

    Charleston, South Carolina, 29425, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Thomas Jefferson University

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

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