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Ultrasound helmet aims to wake the brain after severe injury

NCT ID NCT07694258

Disease control Sponsor: Sunnybrook Health Sciences Centre 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tests a special helmet that sends low-intensity ultrasound waves to deep brain regions in people with disorders of consciousness after severe brain injury. The goal is to see if this approach is safe and can temporarily improve arousal or responsiveness. Ten participants will receive two treatment sessions, with brain imaging and behavioral tests used to measure effects.

What this could mean

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

Active substance
Next Generation Dome Helmet (NGDH) — a device that delivers low-intensity focused ultrasound to specific brain regions
What this could lead to
If successful, this approach could offer a new way to improve arousal and responsiveness in people with long-term consciousness disorders after brain injury.
What could go wrong
This is a very early, small study (10 people) focused on safety and feasibility. It may not show clear benefits, and risks include seizures or other neurological changes.

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

Sep 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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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 severe traumatic brain injury, hypoxic-ischemic brain injury, or other acute brain injury. 2. Glasgow coma scale below 13 when off sedation, or on minimal sedation. 3. Absence of another better explanation for the depressed level of consciousness (e.g,, metabolic abnormality, seizures) 4. Intracranial pressure (ICP) is within a normal range (\< 20 cm H2O), or, a neurosurgeon associated with the study and/or the treating physician agree that ICP is likely \< 20 cm H2O based on clinical and neuroimaging information (acknowledging the limitations of non-invasive assessment of ICP53). 5. The treating physician and/or neurosurgeon associated with the study evaluate it to be safe for the patient to be transported to the MRI scanner for a \~45 minute scan. Exclusion Criteria: 1. Active seizure activity or post-anoxic myoclonus at the time of proposed treatment 2. Taking full anti-coagulation medication (does not include deep-vein-thrombosis chemoprophylaxis) 3. Skull anatomy incompatible with safe FUS delivery (as determined by CT) 4. Medical instability that would preclude safe transport or prolonged supine positioning 5. Presence of any MRI-incompatible implants or devices

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Conditions

The condition(s) this trial relates to.

Consciousness Disorders

As listed by the trial registrant

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

Disorders of consciousness 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

    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

    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

  • Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

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