LIFUP for 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

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

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

Diagnosis of VS or MCS based on the CRS-R

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• BX Pulsar 1002 (LIFUP)

How Is the Trial Designed?

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+

Citations

1. brainstimjrnl.com brainstimjrnl.com/article/S1935-861X(24)00192-X/fulltext

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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11973349/

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.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05147142

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.pdf

BrainSonix 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11591555/

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.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04339972

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 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X21001224

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 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05147142

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 ...