Focused ultrasound to promote recovery after severe brain injury.
Promoting Recovery After Brain Injury Using Focused Ultrasound
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT07277309 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Boston, Massachusetts and 1 other locations
- Massachusetts General Hospital (The General Hospital Corp.) — Boston, Massachusetts, United States (Recruiting)
- Spaulding Rehabilitation Hospital Corporation, Inc. — Cambridge, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Michael Young, MD, MPhil
- Email: michael.young@mgh.harvard.edu
- Phone: 410-808-1196
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.