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Zapping a nerve in the neck may help rewire the brain after traumatic injury

NCT ID NCT07719829

Disease control Sponsor: Stony Brook University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Aug 14, 2026 · Updated 5 times

Summary

This trial tests whether pairing vagus nerve stimulation (VNS) with structured upper limb rehabilitation can improve arm and hand function in people with moderate to severe traumatic brain injury (TBI). Participants will have a small VNS device implanted under the skin that delivers mild electrical pulses to the vagus nerve during therapy sessions. The goal is to see if this paired approach enhances neuroplasticity and leads to better motor recovery than rehabilitation alone.

What this could mean

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

Active substance
vagus nerve stimulation (VNS) paired with upper limb rehabilitation therapy
What this could lead to
If it works, this could point toward a new way to enhance motor recovery after traumatic brain injury.
What could go wrong
This is a small early-stage trial with only 20 participants, and the VNS device requires surgical implantation, which carries risks. Results may not apply to all TBI patients.

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 20 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

22 to 80 years

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: * Age 22-80 years * History of severe TBI (initial GCS ≤ 8) * Regained consciousness with capacity to consent to the study * At least six months since injury * Full recovery of consciousness with command following (mGCS = 6) * Ongoing motor impairment with dependence in activities of daily living (modified Rankin Scale, mRS = 3-4) * Clinically stable for VNS implantation Exclusion Criteria: * No capacity to consent to the study * History of stroke * History of cognitive disorder or other neurodegenerative disorder * History of epilepsy treated by VNS * History of brain tumors (primary or metastatic) * Requires diathermy * Pregnant * Previously implanted vagus nerve stimulator * Extensive prior neck surgery preventing dissection of the vagus nerve * History of severe spasticity, vagus nerve damage, or hearing loss

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

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

TBI (traumatic brain injury) Traumatic brain injury

How to take part

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  1. The official record

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

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  2. A doctor treating you

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