Clinical trial Recruiting at 2 sites Interventional Ages 18 to 79

Focused ultrasound to promote recovery after severe brain injury.

Official title: Promoting Recovery After Brain Injury Using Focused Ultrasound

Run by Massachusetts General Hospital · NCT07277309 · Data updated 2026-11-12

This test uses low-intensity focused ultrasound on adults with disorders of consciousness after severe brain injury to see if it improves responsiveness and brain activity.

More Disorders of Consciousness trials

Quick facts

Study typeInterventional
Ages18 Years to 79 Years
SexAll
Enrollment36 (estimated)
SponsorMassachusetts General Hospital
Academic / other
Locations2 sites (Boston, Massachusetts and 1 other locations)
StatusRecruiting
StartedMay 26, 2026
Main results expectedJuly 2029
Study endsJuly 2029
Registry record updatedJune 15, 2026
Trial IDNCT07277309 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) with a disorder of consciousness due to severe brain injury who are MRI-compatible and have a legally authorized representative available to provide consent are the ideal candidates.

Probably not a fit

Patients with other major neurological disorders, MRI-incompatible metal implants, continuous spontaneous movements that prevent safe MRI, pregnancy, or those enrolled in another therapeutic trial are unlikely to be eligible or to receive benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study enrolls adults with disorders of consciousness after severe brain injury and delivers targeted low-intensity focused ultrasound (LIFUP) while monitoring behavioral responses and brain activity. Neurophysiologic responses are recorded with EEG and advanced MRI is obtained to identify neuroimaging signatures that predict responsiveness. The protocol includes multiple LIFUP sessions with concurrent neurobehavioral testing and neuroimaging. The project also interviews family members and surrogate decision-makers to gather ethical perspectives on therapeutic neuromodulation.

Why it matters

Potential benefit: If successful, this approach could restore or improve wakefulness and responsiveness in some patients and guide personalized, connectome-based neuromodulation therapies.

How similar studies have gone: Other neuromodulation methods (TMS, DBS, tDCS) have produced mixed but sometimes promising results in disorders of consciousness, while low-intensity focused ultrasound is a novel technique with limited human data to date.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Brain injury resulting in DoC diagnosis, following international guidelines
* At least 18 years of age
* Legally authorized representative (surrogate) available to consent

Exclusion Criteria:

* History of neurological disorder other than the brain injury
* Metal implant or other condition precluding MRI
* Manifest continuous spontaneous movement (which would prevent safe/successful MRI)
* Participation in concurrent therapeutic study
* Pregnancy

Where it's running

  • Massachusetts General Hospital (The General Hospital Corp.)
    Boston, Massachusetts, United States
    Recruiting
  • Spaulding Rehabilitation Hospital Corporation, Inc.
    Cambridge, Massachusetts, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.