The Use of LIFUP in Chronic Disorders of Consciousness

Overseen By Jeanette Gumarang, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Casa Colina Hospital and Centers for Healthcare

Disqualifiers: Neurological disorder, Non-MR compatible implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 10 days

16 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are on a psychotropic medication regimen, you will need to keep it stable for at least 4 weeks before joining the study and remain on a stable regimen during the trial.

Research Team

Caroline Schnakers, PhD

Principal Investigator

Casa Colina Hospital and Centers for Healthcare

Martin Monti, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

Inclusion Criteria

Diagnosis of VS or MCS based on the CRS-R

Chronic status: 3 months post-injury for non-traumatic etiologies 12 months post-injury for traumatic etiology 18 years of age or older. If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to entry to the study and the patient will be willing to remain on a stable regimen during the protocol.

Exclusion Criteria

You experience constant involuntary movements that would make it difficult to take images.

You are already participating in another research study.

You have a history of a neurological disorder, except for a brain injury.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 10-day in-patient protocol involving LIFUP, EEG, PET, and polysomnography measurements

10 days

In-patient stay at Casa Colina Hospital

Follow-up

Participants are monitored remotely for safety and effectiveness after treatment

30 days

2 remote follow-up sessions at 7 and 30 days post-discharge

Treatment Details

Interventions

• BX Pulsar 1002 (LIFUP)

Participant Groups

Group I: Treatment LIFUP Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Casa Colina Hospital and Centers for Healthcare

Lead Sponsor

Trials

11

Recruited

350+

UCLA Department of Psychology

Collaborator

Trials

1

Recruited

20+

Tiny Blue Dot INC.

Collaborator

Trials

1

Recruited

20+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Tiny Blue Dot Foundation

Collaborator

Trials

10

Recruited

660+