NCT04921683

The Use of LIFUP in Chronic Disorders of Consciousness

Biomarkers of Thalamic LIFUP in Chronic Disorders of Consciousness

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Casa Colina Hospital and Centers for Healthcare · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

When patients survive a severe brain injury but fail to fully recover, they often enter a Disorder of Consciousness (DoC) --that is, a set of related conditions of decreased awareness and arousal including the Vegetative State (VS) and the Minimally Conscious State (MCS). When these conditions become chronic, there are no approved treatments to help bolster any further recovery. In prior work, we have shown the clinical feasibility and potential of Low Intensity Focused Ultrasound Pulsation (LIFUP) as a remarkably safe form of non-invasive brain stimulation in these conditions.

Detailed description

In the present study, we propose taking the "next step" to assess whether LIFUP can affect objective and validated markers of DoC patient impairment (in the direction of lesser impairment). Specifically, patients will be admitted at Casa Colina Hospital for a 10-day (in-patient) protocol, and two follow-up sessions, conducted remotely (e.g., over the phone) at 7 and 30-days post-discharge. The full length of the study is 40 days from admission. Over the admission period, patients will undergo multiple measurements of validated biomarkers, including behavioral testing, brain metabolism (using Positron Emission Tomography), and electroencephalography, before and after one session of LIFUP to thalamus.

Conditions

• Disorder of Consciousness
• Vegetative State
• Minimally Conscious State
• Minimally Conscious State Plus
• Minimally Conscious State Minus
• Traumatic Brain Injury
• CVA (Cerebrovascular Accident)
• Anoxia, Brain
• Thalamic Infarction
• Coma; Prolonged

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-21
• Primary completion: 2023-03-01
• Completion: 2023-04-14
• First posted: 2021-06-10
• Last updated: 2023-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study