Ultrasound Stimulation for Patients in a Disorder of Consciousness

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 26, 2025

Primary Completion Date

March 28, 2028

Study Completion Date

September 29, 2028

Conditions
Consciousness DisordersDisorders of Consciousness Due to Severe Brain Injury
Interventions
DEVICE

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.

Trial Locations (4)

90095

RECRUITING

The Regents of the University of California, Los Angeles, Los Angeles

91767

RECRUITING

Casa Colina Hospital and Centers for Healthcare, Pomona

02114

NOT_YET_RECRUITING

Massachusetts General Hospital (The General Hospital Corp.), Boston

02129-3109

NOT_YET_RECRUITING

Spaulding Rehabilitation Hospital Corporation, Inc., Charlestown

All Listed Sponsors
collaborator

Casa Colina Hospital and Centers for Healthcare

OTHER

collaborator

Spaulding Rehabilitation Hospital

OTHER

collaborator

Massachusetts General Hospital

OTHER

lead

University of California, Los Angeles

OTHER