LIFUP for Disorders of Consciousness
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called Low Intensity Focused Ultrasound Pulsation (LIFUP) for individuals in a state of reduced consciousness following a severe brain injury. The goal is to determine if LIFUP can improve awareness and arousal in those with long-term conditions like the Vegetative State or Minimally Conscious State. The treatment uses a device that sends gentle ultrasound waves to specific brain areas. This trial may suit individuals diagnosed with a Vegetative or Minimally Conscious State at least 3 months after a non-traumatic brain injury or 12 months after a traumatic injury. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatments for brain injury recovery.
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.
What prior data suggests that this Low Intensity Focused Ultrasound Pulsation (LIFUP) is safe for patients with Disorders of Consciousness?
Research has shown that Low Intensity Focused Ultrasound Pulsation (LIFUP) using the BX Pulsar 1002 device is generally safe for people. LIFUP is a non-invasive treatment, meaning it doesn't involve surgery or cutting the skin, making it less risky than many other treatments. In past studies, patients tolerated the treatment well, and no serious side effects were reported. However, operators of the BX Pulsar 1002 require special training to use it safely. The FDA has permitted its use in research, but it is not yet fully approved for general use. While the treatment appears promising, more research is needed to fully understand its safety.12345
Why are researchers excited about this trial?
Researchers are excited about LIFUP (Low-Intensity Focused Ultrasound Pulsation) for chronic disorders of consciousness because it represents a non-invasive and precisely targeted approach. Unlike traditional treatments that often rely on medications or physical rehabilitation, LIFUP uses focused ultrasound waves to stimulate specific brain regions, potentially reviving brain activity more naturally and directly. This technique also allows for accurate targeting with the help of advanced neuronavigation technology, which might lead to more consistent and effective outcomes for patients with consciousness disorders.
What evidence suggests that LIFUP is effective for Disorders of Consciousness?
Research has shown that Low Intensity Focused Ultrasound Pulsation (LIFUP), the treatment under study in this trial, could help treat long-term consciousness disorders. LIFUP is a non-invasive technique that stimulates specific parts of the brain without surgery. Studies have found that it can safely reach deep brain areas important for consciousness. Although researchers have studied only a small number of patients so far, early results suggest it might improve brain activity in people with these conditions. Overall, LIFUP's safety and ability to accurately target brain areas make it a promising option for those with severe brain injuries.13678
Who Is on the Research Team?
Caroline Schnakers, PhD
Principal Investigator
Casa Colina Hospital and Centers for Healthcare
Martin Monti, PhD
Principal Investigator
University of California, Los Angeles
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a 10-day in-patient protocol involving LIFUP, EEG, PET, and polysomnography measurements
Follow-up
Participants are monitored remotely for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BX Pulsar 1002 (LIFUP)
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Casa Colina Hospital and Centers for Healthcare
Lead Sponsor
UCLA Department of Psychology
Collaborator
Tiny Blue Dot INC.
Collaborator
University of California, Los Angeles
Collaborator
Tiny Blue Dot Foundation
Collaborator
Citations
Low-intensity focused ultrasound (LIFU) for the treatment of ...
There are several limitations to the study. The number of patients is too small to determine the efficacy of LIFU as a treatment for PTH.
Investigating low intensity focused ultrasound pulsation in ...
Low intensity focused ultrasound pulsation (LIFUP) is an emerging technology that enables non-invasive stimulation of these subcortical regions.
NCT05147142 | Low Intensity Focused Ultrasound: a New ...
The primary objectives of this study are to test the safety and tolerability of LIFU, evaluate the feasibility of using LIFU to reduce brain activity, and ...
4.
teams.semel.ucla.edu
teams.semel.ucla.edu/sites/default/files/users/user-739/bxpulsar1002_user_manual_053019.pdfBrainSonix Corp.
The Brainsonix BX Pulsar 1002 was designed to deliver low-intensity focused ultrasound pulsations (LIFUP) to the human brain, and to be safe for simultaneous ...
Preliminary Examination of the Effects of Focused ...
Preliminary examination of the effects of focused ultrasound on living skin and temperature at the skin–transducer interface.
Low Intensity Focused Ultrasound Pulses (LIFUP) to ...
(BX Pulsar 1001). Please see the manufacturers description (Technical Summary) along with appendixes about the actual safety of the device itself. Official ...
Safety of focused ultrasound neuromodulation in humans ...
The BX Pulsar is designed to deliver tFUS energy to the human brain, and to be acceptable for simultaneous use within a 3 T MRI (MR Conditional [23]). The BX ...
NCT05147142 | Low Intensity Focused Ultrasound: a New ...
The primary objectives of this study are to test the safety and tolerability of LIFU, evaluate the feasibility of using LIFU to reduce brain activity, and ...
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