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Ear-Clip nerve zaps may wake hidden awareness after brain injury

NCT ID NCT07719595

Symptom relief Sponsor: Sima Mofakham Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

Some people with severe traumatic brain injury appear unresponsive but may still be aware—a hidden state called cognitive motor dissociation. This pilot trial tests whether gentle electrical pulses delivered through clips on the left ear, stimulating two nerves at once (the vagus and trigeminal nerves), can help them recover consciousness. Ten participants receive one hour of stimulation daily for a week, with recovery measured by standard clinical scoring and an automated camera system that detects tiny voluntary movements invisible to the naked eye.

What this could mean

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

Active substance
a device that delivers gentle electrical pulses through ear-clip electrodes to stimulate the vagus and trigeminal nerves
What this could lead to
If it works, this could offer a non-invasive way to help people with severe brain injury recover awareness and responsiveness.
What could go wrong
This is a very small pilot study with only 10 participants, so results may not apply broadly. The treatment is experimental and its benefits are uncertain.

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 10 people

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

Started

Jun 2026

Expected to finish

Dec 2029

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

18 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: * Age ≥ 18 years * Coma, vegetative state/unresponsive wakefulness syndrome (VS/UWS), or minimally conscious state (MCS) as determined by baseline CRS-R * Acute traumatic brain injury with documented intracranial pathology on neuroimaging * Admission to the Neurology or Neurosurgical ICU * Legally authorized representative (LAR) available and willing to consent, including the Stimulation Addendum Consent Form Exclusion Criteria: * Implanted cardiac pacemaker, vagus nerve stimulator, or other active implanted device * Known cardiac arrhythmia (e.g., 2nd-/3rd-degree AV block, atrial fibrillation with uncontrolled rate) * Active seizures not controlled by current antiepileptic regimen * Skin breakdown, infection, or anatomical abnormality of the left ear precluding electrode placement * Pregnancy * Hemodynamic instability requiring vasopressor escalation at the time of enrollment

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic Coma Coma, Post-Head Injury ocular motor apraxia, Cogan type traumatic brain injury

As listed by the trial registrant

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

Coma, traumatic Disorders of consciousness due to severe brain injury Severe traumatic brain injury Traumatic brain injury

How to take part

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  1. The places running it

    1 site. 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

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Contacts and locations

Locations

  • Stony Brook University Hospital

    RECRUITING

    Stony Brook, New York, 11794, United States

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