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โ† Trials
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Ultrasound Stimulation for Patients in a Disorder of Consciousness

RecruitingNAAges 18 Years - 79 YearsAllUniversity of California, Los Angeles
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • The Brainsonix BX Pulsar 1002 was designed to deliver low-intensity focused ultrasound pulsations (LIFUP) to the human brain.
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Where

4 sites
The Regents of the University of California, Los Angeles
Los Angeles, United States
Casa Colina Hospital and Centers for Healthcare
Pomona, United States
Massachusetts General Hospital (The General Hospital Corp.)
Boston, United States
Spaulding Rehabilitation Hospital Corporation, Inc.
Charlestown, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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