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Ultrasound Stimulation for Patients in a Disorder of Consciousness
Sponsor: University of California, Los Angeles
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.
Official title: Safety and Efficacy of Thalamic Focused Ultrasound Stimulation (tFUS) for Promoting Recovery After Severe Traumatic Brain Injury
Key Details
Gender
All
Age Range
18 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-04-26
Completion Date
2028-09-29
Last Updated
2025-10-10
Healthy Volunteers
No
Interventions
The Brainsonix BX Pulsar 1002 was designed to deliver low-intensity focused ultrasound pulsations (LIFUP) to the human brain.
The BX Pulsar 1002 consists of two main elements: the transducer and the ultrasound console. The transducer itself and the housing for it went through several iterations in order to be compatible with an MRI environment. Currently, the transducer and its housing are deemed MR-conditional at 3T with SAR ≤ 2W/kg. The design includes a solid acoustic coupling gel pad attached to the front of the transducer to provide good acoustic transmission into the scalp. An outer housing was designed to attach the transducer firmly to the head above the temporal window, and to allow it to be moved side to side to accurately target intended structures.
Locations (4)
The Regents of the University of California, Los Angeles
Los Angeles, California, United States
Casa Colina Hospital and Centers for Healthcare
Pomona, California, United States
Massachusetts General Hospital (The General Hospital Corp.)
Boston, Massachusetts, United States
Spaulding Rehabilitation Hospital Corporation, Inc.
Charlestown, Massachusetts, United States