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Could sound waves wake the brain? new trial tests ultrasound for severe injury

NCT ID NCT06939348

Disease control Sponsor: University of California, Los Angeles 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026

Summary

This study tests whether low-intensity focused ultrasound (tFUS) can help people with severe traumatic brain injury who have not fully recovered consciousness. Researchers will compare real tFUS to a sham (fake) treatment in 60 participants, measuring changes in consciousness using a standard scale. The goal is to see if this non-invasive device is safe and can promote recovery.

What this could mean

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

Active substance
Low-intensity focused ultrasound (tFUS) delivered by the Brainsonix BX Pulsar 1002 device
What this could lead to
If it works, this could point toward a new way to help people with severe brain injuries regain consciousness and improve neurological function.
What could go wrong
This is an early-stage study with only 60 participants, so results may not apply to everyone. The treatment is experimental and may not work better than a sham procedure.

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 60 people

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

Started

Apr 2025

Expected to finish

Sep 2028

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 to 79 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: 1. Diagnosis of DoC, following international guidelines, as assessed with the CRS-R. 2. Prolonged status (\>28days post-injury) 3. If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to entry to the study and the patient will be willing to remain on a stable regimen during the protocol. 4. legally authorized representative available to consent for the patient to participate in the study Exclusion Criteria: 1. History of neurological disorder (other than the brain injury). 2. Metal implant or other condition precluding safe entry in the MR-environment. 3. Manifest continuous spontaneous movement (which would prevent safe/successful imaging). 4. Participation in another concurrent clinical trial. 5. Need for mechanical ventilation. 6. Craniotomy (no bone flap). 7. Cranioplasty spanning the left temporal bone window.

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic Coma Consciousness Disorders Hypoxia, Brain Persistent Vegetative State stroke disorder traumatic brain injury

As listed by the trial registrant

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

Consciousness disorders Disorders of consciousness due to severe brain injury

How to take part

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

  1. The places running it

    4 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

  • Casa Colina Hospital and Centers for Healthcare

    RECRUITING

    Pomona, California, 91767, United States

  • Massachusetts General Hospital (The General Hospital Corp.)

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Spaulding Rehabilitation Hospital Corporation, Inc.

    NOT_YET_RECRUITING

    Charlestown, Massachusetts, 02129-3109, United States

  • The Regents of the University of California, Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

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