NCT06939348 Ultrasound Stimulation for Patients in a Disorder of Consciousness
| NCT ID | NCT06939348 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | Consciousness Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-04-26 |
| Primary Completion | 2028-03-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-04-26 with a primary completion date of 2028-03-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Martin M Monti, PhD
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT06939348 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Consciousness Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06939348 currently recruiting?
Yes, NCT06939348 is actively recruiting participants. Contact the research team at monti@psych.ucla.edu for enrollment information.
Where is the NCT06939348 trial being conducted?
This trial is being conducted at Los Angeles, United States, Pomona, United States, Boston, United States, Charlestown, United States.
Who is sponsoring the NCT06939348 clinical trial?
NCT06939348 is sponsored by University of California, Los Angeles. The principal investigator is Martin M Monti, PhD at University of California, Los Angeles. The trial plans to enroll 60 participants.