Ultrasound helmet aims to wake the brain after severe injury

NCT ID NCT07694258

Recruiting now Disease control Sponsor: Sunnybrook Health Sciences Centre Source: ClinicalTrials.gov ↗

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.

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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

Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••
Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Sunnybrook Health Sciences Centre
RECRUITING

Toronto, Ontario, M4N 3M5, Canada

Contact Phone: •••-•••-•••• Email: •••••@•••••

Contact Phone: •••-•••-•••• Email: •••••@•••••

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