Actively Recruiting

Phase Not Applicable
Age: 18Years - 79Years
All Genders
ID06939348

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

Led by University of California, Los Angeles · Updated on 2026-05-22

60

Participants Needed

4

Research Sites

26 weeks

Total Duration

On this page

Sponsors

U

University of California, Los Angeles

Lead Sponsor

C

Casa Colina Hospital and Centers for Healthcare

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of low-intensity focused ultrasound stimulation (tFUS) to help patients with prolonged disorders of consciousness (DoC) due to severe brain injury, particularly traumatic brain injury (TBI). This multicenter study aims to test whether tFUS can promote recovery of consciousness and improve functional outcomes compared to a sham treatment. The study also seeks to assess the safety of different doses of tFUS and explore brain activity changes and biomarkers related to treatment response. Participants will be randomly assigned to one of two groups: one group will receive two sessions of tFUS, while the other will receive a sham sonication in the first session followed by one tFUS session in the second. The intervention uses the Brainsonix BX Pulsar 1002 device, which delivers ultrasound pulses to targeted brain areas through a specially designed transducer compatible with MRI. The study includes assessments before and one week after treatment sessions, with additional EEG recordings to evaluate changes in brain activity. During the study, researchers will measure recovery using the Coma Recovery Scale Revised and the Disability Rating Scale. Safety will be monitored by tracking adverse events and vital signs within one week after treatment. EEG scans will assess changes in brain connectivity. The study will also include patients with DoC from non-TBI causes to compare responses. Participation involves baseline and follow-up assessments, EEG recordings, and monitoring over a 16-day period.

CONDITIONS

Brief Title

Ultrasound Stimulation for Patients in a Disorder of Consciousness

Who Can Participate

Age: 18Years - 79Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of disorder of consciousness following international guidelines, confirmed with the Coma Recovery Scale Revised
  • Prolonged status of more than 28 days post-injury
  • Stable psychotropic medication regimen for at least 4 weeks prior to study entry and willingness to remain on it during the study
  • Legally authorized representative available to provide consent for participation
Not Eligible

You will not qualify if you...

  • History of neurological disorders other than the brain injury
  • Metal implant or other condition that makes MRI unsafe
  • Continuous spontaneous movement preventing safe imaging
  • Participation in another concurrent clinical trial
  • Need for mechanical ventilation
  • Craniotomy without bone flap
  • Cranioplasty involving the left temporal bone window

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 16 days

Participants receive either active thalamic focused ultrasound stimulation (tFUS) or sham sonication in two separate sessions to assess recovery in prolonged disorders of consciousness.

2 sessions over approximately 2 weeks

Follow-up

Duration - 1 week

Participants undergo assessments one week after the intervention sessions to evaluate safety, efficacy, and brain activity changes.

1 visit (in-person) for outcome assessments

Trial Site Locations

Total: 4 locations

1

The Regents of the University of California, Los Angeles

Los Angeles, California, United States, 90095

Actively Recruiting

2

Casa Colina Hospital and Centers for Healthcare

Pomona, California, United States, 91767

Actively Recruiting

3

Massachusetts General Hospital (The General Hospital Corp.)

Boston, Massachusetts, United States, 02114

Actively Recruiting

4

Spaulding Rehabilitation Hospital Corporation, Inc.

Charlestown, Massachusetts, United States, 02129-3109

Not Yet Recruiting

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Research Team

M

Martin M Monti, PhD

C

Caroline Schnakers, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Treating Disorders of Consciousness With Apomorphine: Protocol for a Double-Blind Randomized Controlled Trial Using Multimodal Assessments.

Leandro R D Sanz, Nicolas Lejeune, Séverine Blandiaux...

https://pubmed.ncbi.nlm.nih.gov/30941094

Test-Retest Reliability of Traumatic Brain Injury Outcome Measures: A Traumatic Brain Injury Model Systems Study.

Jennifer A Bogner, Gale G Whiteneck, Jessica MacDonald...

https://pubmed.ncbi.nlm.nih.gov/28195954