Status:
RECRUITING
Ultrasound Stimulation for Patients in a Disorder of Consciousness
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Casa Colina Hospital and Centers for Healthcare
Spaulding Rehabilitation Hospital
Conditions:
Consciousness Disorders
Disorders of Consciousness Due to Severe Brain Injury
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief 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 ...
Detailed Description
Aim 1 - Establish short-term efficacy of tFUS as a therapeutic to promote recovery in patients with prolonged DoC as compared to sham treatment. Investigators will use a multicenter sham-controlled ra...
Eligibility Criteria
Inclusion
- 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
Exclusion
- History of neurological disorder (other than the brain injury).
- Metal implant or other condition precluding safe entry in the MR-environment.
- Manifest continuous spontaneous movement (which would prevent safe/successful imaging).
- Participation in another concurrent clinical trial.
- Need for mechanical ventilation.
- Craniotomy (no bone flap).
- Cranioplasty spanning the left temporal bone window.
Key Trial Info
Start Date :
April 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 29 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06939348
Start Date
April 26 2025
End Date
September 29 2028
Last Update
October 10 2025
Active Locations (4)
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1
The Regents of the University of California, Los Angeles
Los Angeles, California, United States, 90095
2
Casa Colina Hospital and Centers for Healthcare
Pomona, California, United States, 91767
3
Massachusetts General Hospital (The General Hospital Corp.)
Boston, Massachusetts, United States, 02114
4
Spaulding Rehabilitation Hospital Corporation, Inc.
Charlestown, Massachusetts, United States, 02129-3109