← Back to Search

Low Intensity Focused Ultrasound Pulsation

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

Study Summary

This trial is testing whether LIFUP can help improve recovery in patients in a chronic vegetative or minimally conscious state.

Eligible Conditions

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Coma Recovery Scale-Revised

Electroencephalography

Polysomnography

+1 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Casa Colina Hospital and Centers for HealthcareLead Sponsor

9 Previous Clinical Trials

285 Total Patients Enrolled

UCLA Department of PsychologyUNKNOWN

Tiny Blue Dot INC.UNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any availability for individuals to join this research program?

"Per the information provided on clinicaltrials.gov, this medical trial is open for enrolment and will accept participants until further notice. It was initially posted on June 21st 2021 and has been recently updated as of March 9th 2022."

Answered by AI

What is the current participant count for this medical experiment?

"Correct. Clinicaltrials.gov details that the research, which was originally published on June 21st 2021, is actively recruiting volunteers. 40 participants are needed at one medical centre for this investigation to be successful."

Answered by AI