BX Pulsar 1002 (LIFUP) Low intensity Focused Ultrasound Pulsation for Disorders of Consciousness

N/A

Waitlist Available

Led By Caroline Schnakers, PhD

Research Sponsored by Casa Colina Hospital and Centers for Healthcare

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up coma recovery scale-revised is completed at enrollment and twice a day on day 1-10, except for day 4. maximum score is 23 with a minimum of 0. higher scores mean better outcome.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether LIFUP, a technique using sound waves to stimulate the brain, can help patients with chronic Disorders of Consciousness like Vegetative State or Minimally Conscious State. The goal is to see if this method can improve their awareness and responsiveness by targeting the thalamus. This technique has been studied for its potential to modulate brain activity non-invasively, showing promise in treating neurological conditions such as epilepsy and Parkinson's disease.

Eligible Conditions

Disorders of Consciousness
Vegetative State
Coma
Stroke
Minimally Conscious State
Traumatic Brain Injury
Brain Anoxia
Thalamic Stroke

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ coma recovery scale-revised is completed at enrollment and twice a day on day 1-10, except for day 4. maximum score is 23 with a minimum of 0. higher scores mean better outcome.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~coma recovery scale-revised is completed at enrollment and twice a day on day 1-10, except for day 4. maximum score is 23 with a minimum of 0. higher scores mean better outcome.

This trial's timeline: 3 weeks for screening, Varies for treatment, and coma recovery scale-revised is completed at enrollment and twice a day on day 1-10, except for day 4. maximum score is 23 with a minimum of 0. higher scores mean better outcome. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Coma Recovery Scale-Revised

Electroencephalography

Polysomnography

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment LIFUPExperimental Treatment1 Intervention

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 to minimize bone absorption and refraction. Accurate aiming will be ensured using the Brain Sight neuronavigation device, customized for tracking our LIFUP transducer. Following LIFUP, the patient will undergo a second EEG session, except for the EEG cap being fit to the patient's head prior to the LIFUP session so that, as soon as LIFUP administration is complete, the EEG paradigm can be promptly administered. The patient will then be allowed to rest (\~1h).The patient will then be administered a second dose of tracer in order to undergo a second PET measurement. Finally, at the end-of-day, the clinical coordinator will collect an Adverse Event Questionnaire and will fit the PSG device for night monitoring.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BX Pulsar 1002 (LIFUP) Low intensity Focused Ultrasound Pulsation

2021

N/A

~20

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