What is this study trying to find out about disorders of consciousness?

This study is evaluating whether low-intensity focused ultrasound stimulation (tFUS) can help patients with prolonged disorders of consciousness recover better than with a sham treatment. It also aims to assess the safety of different doses and explore brain activity changes related to treatment. The study is sponsored by the University of California, Los Angeles.

Who may be eligible for this disorders of consciousness clinical trial?

Adults aged 18 to 79 with a prolonged disorder of consciousness lasting more than 28 days after brain injury may be eligible. Participants must have a stable psychotropic medication regimen if applicable and have a legally authorized representative to consent. Please review eligibility criteria for more details.

Is there any cost to participate in this disorders of consciousness clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel or accommodation expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 79Years

All Genders

ID06939348

Focused Ultrasound Treatment to Help Recovery After Severe Brain Injury in Patients with Disorders of Consciousness

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

Participants Needed

Research Sites

26 weeks

Total Duration

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

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	tFUS	Sham tFUS
What it is	Low-intensity focused ultrasound pulsation (LIFUP) delivered to the thalamic region using the Brainsonix BX Pulsar 1002 device.	A sham procedure that mimics all aspects of tFUS setup and patient handling but does not deliver active ultrasound energy.
Role in trial	Investigational treatment arm, evaluating the safety and short-term effects of tFUS in disorders of consciousness after severe brain injury.	Control arm, mimicking the experimental intervention without active ultrasound to serve as a comparator.
Primary use	Being investigated for its potential to promote recovery and improve consciousness in patients with prolonged DoC following severe brain injury.	Serves as a control for comparison; no expected therapeutic effect.
How it is given or performed	The BX Pulsar 1002 transducer is attached above the temporal window and delivers LIFUP targeting intended brain structures; designed for compatibility with MRI scans and secure head placement.	Participants undergo identical device placement and procedures, but active ultrasound delivery is withheld to maintain blinding.
Evidence status	Initial case reports and pilot studies suggest possible benefits of thalamic ultrasound neuromodulation in patients with disorders of consciousness, but high-quality evidence remains limited and results are preliminary.	Sham stimulation is not expected to improve consciousness; serves as a control to isolate the effects of active tFUS.
Important limitations	Efficacy and safety have not yet been established in large, well-controlled studies. Outcomes may differ due to individual injury characteristics, device targeting, or other factors. Further investigation is needed to confirm whether tFUS meaningfully improves recovery.	As an inactive control, the sham procedure cannot offer therapeutic benefit; it provides important internal validity but is not a current or future treatment option.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years - 79Years

All Genders

Eligibility Criteria

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

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

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