Actively Recruiting
Promoting Recovery After Brain Injury Using Focused Ultrasound
Led by Massachusetts General Hospital · Updated on 2026-02-18
36
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to develop a treatment to help patients who survive severe brain injury but do not fully recover, focusing on those with disorders of consciousness (DoC). It evaluates responses to low-intensity focused ultrasound (LIFUP) and studies ethical views of family members and surrogate decision-makers regarding this therapy. The project seeks to create a personalized approach using brain connectivity patterns and to establish ethical guidelines for such treatments. Participants will receive low-intensity focused ultrasound therapy targeting the brain. They will also undergo advanced MRI scans and EEG tests to assess brain activity and response. Family members or surrogate decision-makers, as well as recovered patients, will participate in interviews to share their perspectives on using neuromodulation treatments like LIFUP. During the study, researchers will measure neurobehavioral responses using scales like the Coma Recovery Scale - Revised and Disability Rating Scale over three days. EEG responses to the treatment will also be recorded. Advanced brain imaging will be used to predict treatment responsiveness. The study includes ethical evaluations from patient representatives. This monitoring and assessment period lasts for three days after treatment, with the entire study running until July 2029.
CONDITIONS
Brief Title
Promoting Recovery After Brain Injury Using Focused Ultrasound
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Brain injury resulting in disorder of consciousness diagnosis following international guidelines
- At least 18 years of age
- Legally authorized representative (surrogate) available to consent
You will not qualify if you...
- History of neurological disorder other than the brain injury
- Metal implant or other condition preventing MRI
- Continuous spontaneous movement preventing safe MRI
- Participation in another therapeutic study
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants will receive low-intensity focused ultrasound (LIFUP) intervention along with advanced MRI and EEG assessments. Surrogate decision makers and recovered patients will participate in semi-structured interviews.
3 consecutive days of visits (in-person)
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital (The General Hospital Corp.)
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Spaulding Rehabilitation Hospital Corporation, Inc.
Cambridge, Massachusetts, United States, 02138
Actively Recruiting
Research Team
M
Michael Young, MD, MPhil
J
Jason Lew, DO
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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