Safety and Efficacy of Thalamic Focused Ultrasound Stimulation (tFUS) for Promoting Recovery After Severe Traumatic Brain Injury

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The overall aim of this study is to develop an intervention that can help recovery in patients surviving severe brain injury but failing to fully recover. In particular, this multicenter project aims to (1) establish short-term efficacy of tFUS as a therapeutic to promote recovery in patients with prolonged DoC as compared to sham treatment, (2) establish dose-related safety and efficacy of tFUS as a therapeutic intervention in prolonged DoC patients and (3) explore preliminary predictors and biomarkers of susceptibility and response to thalamic sonication.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
View:

• Diagnosis of DoC, following international guidelines, as assessed with the CRS-R.

• Prolonged status (\>28days post-injury)

• If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to entry to the study and the patient will be willing to remain on a stable regimen during the protocol.

• legally authorized representative available to consent for the patient to participate in the study

Locations
United States
California
The Regents of the University of California, Los Angeles
RECRUITING
Los Angeles
Casa Colina Hospital and Centers for Healthcare
RECRUITING
Pomona
Massachusetts
Massachusetts General Hospital (The General Hospital Corp.)
NOT_YET_RECRUITING
Boston
Spaulding Rehabilitation Hospital Corporation, Inc.
NOT_YET_RECRUITING
Charlestown
Contact Information
Primary
Martin M Monti, PhD
monti@psych.ucla.edu
310-825-8546
Backup
Caroline Schnakers, PhD
cschnakers@casacolina.org
(909) 596-7733
Time Frame
Start Date: 2025-04-26
Estimated Completion Date: 2028-09-29
Participants
Target number of participants: 60
Treatments
Sham_comparator: Sham-tFUS group
Sham-tFUS group will receive sham sonication in the first session and tFUS in the second session
Active_comparator: tFUS-tFUS group
tFUS-tFUS group will receive 2 sessions of tFUS
Related Therapeutic Areas
Sponsors
Leads: University of California, Los Angeles
Collaborators: Casa Colina Hospital and Centers for Healthcare, Spaulding Rehabilitation Hospital, Massachusetts General Hospital

This content was sourced from clinicaltrials.gov