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Stroke recovery gets a boost: Brain-Device combo tracked in 1,000 patients

NCT ID NCT05301140

Disease control Sponsor: MicroTransponder 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times

Summary

This registry is collecting real-world data from 1,000 people who have arm and hand weakness after a stroke and have received the Vivistim System. The device delivers mild electrical pulses to the vagus nerve while patients do rehabilitation exercises. Researchers will track changes in arm function and daily activity to see how well the therapy works outside of controlled studies.

What this could mean

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

Active substance
Vivistim System (implanted device delivering vagus nerve stimulation paired with rehabilitation movements)
What this could lead to
If successful, this registry could confirm that Vivistim paired with rehab improves arm and hand function after stroke in real-world settings.
What could go wrong
This is an observational registry, not a controlled trial, so results may be influenced by patient selection or other factors. The device requires surgery, which carries risks like infection or implant complications.

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.

Participants

About 1,000 people

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

Started

Mar 2023

Expected to finish

Dec 2028

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.

Who is studied

Ischemic stroke patients implanted with the Vivistim System

Ages

22 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.

Inclusion Criteria: * Patients implanted with the Vivistim System for upper limb deficits associated with an ischemic stroke Exclusion Criteria: * Not eligible for surgery

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Conditions

The condition(s) this trial relates to.

Ischemic Stroke

As listed by the trial registrant

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

Upper extremity problem

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

  • Advent Health Orlando

    RECRUITING

    Orlando, Florida, 32803, United States

  • Albany Medical College

    RECRUITING

    Albany, New York, 12208, United States

  • Alexian Brothers Health System

    RECRUITING

    Elk Grove Village, Illinois, 60007, United States

  • Allegheny General Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Allied Services Institute of Rehabilitation Medicine

    RECRUITING

    Scranton, Pennsylvania, 18501, United States

  • Burke Rehabilitation Hospital

    RECRUITING

    White Plains, New York, 10605, United States

  • Endeavor Health

    RECRUITING

    Evanston, Illinois, 60201, United States

  • Jefferson Health - Lehigh Valley Health Network

    RECRUITING

    Allentown, Pennsylvania, 18103, United States

  • Mt. Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Overlook Medical Center-Atlantic Health

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Physical Medicine and Neurotoxin Institute

    RECRUITING

    Austin, Texas, 78759, United States

  • St David's Medical Center

    RECRUITING

    Austin, Texas, 78701, United States

  • Thomas Jefferson

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Kentucky Research Foundation

    RECRUITING

    Lexington, Kentucky, 40506, United States

More trials for these conditions

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