Targeted thalamic ultrasound to help recovery after severe brain injury

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

This will try focused ultrasound to the thalamus to see if it helps people with a prolonged disorder of consciousness after traumatic brain injury.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 79 Years
• Sex: All
• Sponsor: University of California, Los Angeles (other)
• Locations: 4 sites (Los Angeles, California and 3 other locations)
• Trial ID: NCT06939348 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Patients with a diagnosis of prolonged disorder of consciousness (>28 days post–traumatic brain injury) confirmed by CRS-R, with a legally authorized representative to consent and stable psychotropic medication regimens, are the intended participants.

Not a fit: Patients with non‑TBI causes of DoC, unstable medical needs (including mechanical ventilation), certain skull surgeries or implants, or MRI contraindications are unlikely to be eligible or to derive benefit from this protocol.

Why it matters

Potential benefit: If successful, tFUS could speed recovery of consciousness and improve functional outcomes for some patients with prolonged DoC after TBI.

How similar studies have performed: Small pilot studies and prior procedures have reported preliminary signals that thalamic focused ultrasound can modulate arousal, but randomized controlled evidence in prolonged DoC is still limited.

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.

Where this trial is running

Los Angeles, California and 3 other locations

• 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 (NOT_YET_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

Conditions: Consciousness Disorders, Disorders of Consciousness Due to Severe Brain Injury, Disorder of Consciousness, Vegetative State, Minimally Conscious State, Minimally Conscious State Plus, Minimally Conscious State Minus, Traumatic Brain Injury