Ultrasound Stimulation for Patients in a Disorder of Consciousness
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Consciousness Disorders, Disorders of Consciousness Due to Severe Brain Injury
In brief
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.
Key facts
- Study ID
- NCT06939348
- Run by
- University of California, Los Angeles
- People needed
- 60
- Starts
- 2025-04-26
- Expected to finish
- 2028-09-29
- Last updated by the study team
- 2026-05-22
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- The Regents of the University of California, Los Angeles — Los Angeles, California, United States (enrolling)
- Casa Colina Hospital and Centers for Healthcare — Pomona, California, United States (enrolling)
- Massachusetts General Hospital (The General Hospital Corp.) — Boston, Massachusetts, United States (enrolling)
- Spaulding Rehabilitation Hospital Corporation, Inc. — Charlestown, Massachusetts, United States
Full record on ClinicalTrials.gov
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