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Ultrasound Stimulation for Patients in a Disorder of Consciousness

Recruiting

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

Who can join

Ages 18 to 79 · All sexes

Full eligibility criteria

Inclusion Criteria:

1. Diagnosis of DoC, following international guidelines, as assessed with the CRS-R.
2. Prolonged status (\>28days post-injury)
3. 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.
4. legally authorized representative available to consent for the patient to participate in the study

Exclusion Criteria:

1. History of neurological disorder (other than the brain injury).
2. Metal implant or other condition precluding safe entry in the MR-environment.
3. Manifest continuous spontaneous movement (which would prevent safe/successful imaging).
4. Participation in another concurrent clinical trial.
5. Need for mechanical ventilation.
6. Craniotomy (no bone flap).
7. Cranioplasty spanning the left temporal bone window.

About the study

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.

What is being tested

The Brainsonix BX Pulsar 1002 was designed to deliver low-intensity focused ultrasound pulsations (LIFUP) to the human brain. (device)

Sponsor: University of California, Los Angeles · Participants: 60 · Started: Apr 26, 2025

Contact the study team

Martin M Monti, PhD · Phone: 310-825-8546
Caroline Schnakers, PhD · Phone: (909) 596-7733

Official record on ClinicalTrials.gov — NCT06939348

Locations in the U.S.

California	The Regents of the University of California, Los Angeles, Los Angeles Casa Colina Hospital and Centers for Healthcare, Pomona
Massachusetts	Massachusetts General Hospital (The General Hospital Corp.), Boston Spaulding Rehabilitation Hospital Corporation, Inc., Charlestown (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.