The Use of LIFUP in Chronic Disorders of Consciousness

NACompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

June 21, 2021

Primary Completion Date

March 1, 2023

Study Completion Date

April 14, 2023

Conditions
Disorder of ConsciousnessVegetative StateMinimally Conscious StateMinimally Conscious State PlusMinimally Conscious State MinusTraumatic Brain InjuryCVA (Cerebrovascular Accident)Anoxia, BrainThalamic InfarctionComa; Prolonged
Interventions
DEVICE

BX Pulsar 1002 (LIFUP) Low intensity Focused Ultrasound Pulsation

"Administration of LIFUP will be performed at the bedside using frameless stereotaxy. Specifically, the LIFUP transducer will be fit to the patient's head employing adjustable straps, and will be positioned over the patient's left temporal bone, over the temporal window in order to minimize bone absorption and refraction. Accurate aiming will be ensured employing the BrainSight neuronavigation device, customized for tracking our LIFUP transducer (total \~10 min). Once satisfactory aiming is achieved, the LIFUP exposure will be initiated employing the settings described previously (which meet the FDA safety limits: ISPPA \<= 190W/cm2, ISPTA \<= 0.72W/cm2). Accurate aiming will be monitored in real-time throughout exposure using the Brain Sight Neuronavigation interface."

Trial Locations (1)

91709

Casa Colina Hospital, Pomona

All Listed Sponsors
collaborator

University of California, Los Angeles

OTHER

collaborator

Tiny Blue Dot Foundation

OTHER

lead

Casa Colina Hospital and Centers for Healthcare

OTHER