RecruitingNot ApplicableNCT06939348

Ultrasound Stimulation for Patients in a Disorder of Consciousness

Safety and Efficacy of Thalamic Focused Ultrasound Stimulation (tFUS) for Promoting Recovery After Severe Traumatic Brain Injury

Sponsor

University of California, Los Angeles

Enrollment

60 participants

Start Date

Apr 26, 2025

Study Type

INTERVENTIONAL

Conditions

Consciousness Disorders Disorders of Consciousness Due to Severe Brain Injury

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

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called The Brainsonix BX Pulsar 1002 was designed to deliver low-intensity focused ultrasound pulsations (LIFUP) to the human brain. for people with consciousness disorders and disorders of consciousness due to severe brain injury. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years to 79 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEThe 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.