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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 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

Find a Location

Who is running the clinical trial?

Casa Colina Hospital and Centers for HealthcareLead Sponsor
9 Previous Clinical Trials
289 Total Patients Enrolled
UCLA Department of PsychologyUNKNOWN
Tiny Blue Dot INC.UNKNOWN
~4 spots leftby Jun 2025
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