Ultrasound Stimulation for Patients in a Disorder of Consciousness

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Apr 14, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called transcranial focused ultrasound (tFUS) to help patients who have severe brain injuries and are not fully conscious. The study aims to see if this ultrasound therapy can promote recovery in patients who have been in a disorder of consciousness (DoC) for more than 28 days. Researchers want to compare the effects of tFUS with a sham treatment (which does not provide the active therapy) to understand how effective and safe it is, and they will also look for early signs that might help identify which patients could benefit from this treatment.

To be eligible for this trial, patients need to have a diagnosis of DoC confirmed by specific guidelines and have been in this state for at least 28 days. They also need to have a stable medication routine for at least four weeks before joining the study. Family members or legally authorized representatives will need to give consent for the patient to participate. Importantly, the study is not yet recruiting participants, but once it begins, those who join can expect to undergo ultrasound treatments and be closely monitored for their progress and safety. This trial is significant as it could lead to new ways to support recovery for individuals with severe brain injuries.

Gender

ALL

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.