RecruitingNot Applicable

Ultrasound Stimulation for Patients in a Disorder of Consciousness

United States60 participantsStarted 2025-04-26

Plain-language summary

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.

Who can participate

Age range

18 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. History of neurological disorder (other than the brain injury).
. Metal implant or other condition precluding safe entry in the MR-environment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Establish short-term efficacy of tFUS as a therapeutic to promote recovery in patients with prolonged DoC as compared to sham treatment.

Timeframe: From Day 1 to 16

Establish dose-related safety and efficacy of tFUS as a therapeutic intervention in prolonged DoC patients.

Timeframe: From Day 1 to 16

Explore preliminary predictors and biomarkers of susceptibility and response to thalamic sonication.

Timeframe: From Day 1 to 16

Trial details

NCT IDNCT06939348

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-28

Contact for this trial

Martin M Monti, PhD

310-825-8546 monti@psych.ucla.edu

View on ClinicalTrials.gov More Consciousness Disorders trials

Plain-language summary

Who can participate

Age range

18 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. History of neurological disorder (other than the brain injury).
. Metal implant or other condition precluding safe entry in the MR-environment.

What they're measuring

Establish short-term efficacy of tFUS as a therapeutic to promote recovery in patients with prolonged DoC as compared to sham treatment.

Timeframe: From Day 1 to 16

Establish dose-related safety and efficacy of tFUS as a therapeutic intervention in prolonged DoC patients.

Timeframe: From Day 1 to 16

Explore preliminary predictors and biomarkers of susceptibility and response to thalamic sonication.

Timeframe: From Day 1 to 16