Actively Recruiting
Ultrasound Stimulation for Patients in a Disorder of Consciousness
Led by University of California, Los Angeles · Updated on 2025-10-10
60
Participants Needed
4
Research Sites
178 weeks
Total Duration
On this page
Sponsors
U
University of California, Los Angeles
Lead Sponsor
C
Casa Colina Hospital and Centers for Healthcare
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ultrasound Stimulation for Patients in a Disorder of Consciousness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of disorder of consciousness following international guidelines as assessed with the Coma Recovery Scale Revised (CRS-R)
- Prolonged disorder of consciousness status longer than 28 days post-injury
- Stable psychotropic medication regimen for at least 4 weeks before study entry and willingness to remain stable during the study
- Legally authorized representative available to provide consent for participation
You will not qualify if you...
- History of neurological disorder other than the brain injury
- Metal implants or other conditions preventing safe MRI entry
- Continuous spontaneous movement that would prevent safe or successful imaging
- Participation in another clinical trial at the same time
- Need for mechanical ventilation
- Craniotomy without a bone flap
- Cranioplasty involving the left temporal bone window
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
The Regents of the University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
2
Casa Colina Hospital and Centers for Healthcare
Pomona, California, United States, 91767
Actively Recruiting
3
Massachusetts General Hospital (The General Hospital Corp.)
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
4
Spaulding Rehabilitation Hospital Corporation, Inc.
Charlestown, Massachusetts, United States, 02129-3109
Not Yet Recruiting
Research Team
M
Martin M Monti, PhD
CONTACT
C
Caroline Schnakers, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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