Targeted thalamic ultrasound to help recovery after severe brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, double-blind, sham-controlled randomized study tests low-intensity focused ultrasound (tFUS) delivered to the thalamus in patients with prolonged disorders of consciousness after traumatic brain injury. Forty patients more than 28 days post-injury will be randomized to either two active tFUS sessions or a sham session followed by tFUS, with assessments before and one week after sonication. Primary outcome is the Coma Recovery Scale–Revised (CRS-R) and a secondary outcome is the Disability Rating Scale, while safety, dose effects, and preliminary biomarkers of response will also be examined. The procedure uses the Brainsonix BX Pulsar 1002 and the sham mimics the setup using a non-transmitting gel pad.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Martin M Monti, PhD — University of California, Los Angeles
• Study coordinator: Martin M Monti, PhD
• Email: monti@psych.ucla.edu
• Phone: 310-825-8546

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Focused ultrasound to promote recovery after severe brain injury.

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• Focusing ultrasound to the central thalamus to help people with disorders of consciousness

  This study tests whether two sessions of low-intensity focused ultrasound can safely help people with severe brain injuries see if they become more awake or responsive.

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• Transcutaneous Electrical Acupoint Stimulation at Hand Jing-Well Points for Disorders of Consciousness

  We test a noninvasive electrical stimulation at hand points to see if it can help people who have altered consciousness after severe brain injury.

  Recruiting Phase 2/3 Xijing Hospital · Xi'an, Shaanxi · NCT07535593

• Can a bedside brain scan (fNIRS) detect activity in healthy people and in people with disorders of consciousness

  This observational study tests whether functional near-infrared spectroscopy (fNIRS) can measure brain activity at the bedside in healthy adults and in patients with disorders of consciousness in the Neuro-ICU.

  Recruiting University of California, Los Angeles · Los Angeles, California · NCT07485361

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.