LIFUP Neuromodulation for Healthy Controls

Overseen By Andrea Boscutti, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Psychotropic medications

Disqualifiers: Smoking, Pregnancy, Claustrophobia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new technique called low-intensity focused ultrasound pulsation (LIFUP) to assess its effects on emotions and brain activity. Researchers aim to determine if LIFUP can safely stimulate or calm specific brain areas in healthy individuals. Participants should be right-handed, healthy, and not using drugs or certain medications. The trial may suit those without ongoing medical or mental health issues. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research in brain stimulation techniques.

Will I have to stop taking my current medications?

Yes, you must stop taking any psychotropic medications (drugs that affect your mind) at least 14 days before participating in the trial.

What prior data suggests that LIFUP sonication is safe for neuromodulation?

Research shows that Low-Intensity Focused Ultrasound Pulsation (LIFUP) is a non-invasive technique using gentle sound waves to influence brain activity. This method avoids surgery and can target specific brain areas. However, scientists continue to study its safety and overall effects.

Some studies have found that LIFUP can decrease activity in the amygdala, which processes emotions, during tasks related to social and emotional processing. This suggests possible benefits, but its safety is not yet fully understood.

This trial falls under the "Not Applicable" category, indicating a lack of specific safety data from earlier studies. Such trials typically aim to understand how the treatment works rather than focusing on its safety in humans. While LIFUP appears promising, further research is necessary to ensure its safety for people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about LIFUP sonication because it offers a novel approach to neuromodulation by targeting the amygdala with focused ultrasound waves. Unlike traditional treatments that rely on medication or invasive procedures, LIFUP (Low-Intensity Focused Ultrasound Pulsation) is non-invasive and aims to modulate brain activity with precision. This technique holds promise for influencing emotional and behavioral responses without the side effects associated with pharmacological interventions.

What evidence suggests that LIFUP sonication is effective for neuromodulation?

Research has shown that low-intensity focused ultrasound pulsation (LIFUP) on the amygdala can calm this brain region during emotional activities. In this trial, participants will receive LIFUP sonication to the amygdala. Studies have found that LIFUP on the amygdala can noticeably improve mood and reduce anxiety symptoms, as evidenced by a significant drop in scores on a mood and anxiety questionnaire. LIFUP effectively targets the amygdala, which can be overly active in people with mood and anxiety disorders. This treatment is promising because it is non-invasive and can precisely focus on specific brain areas. ^{1 2 3 5 6}

Who Is on the Research Team?

Jair C Soares, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for right-handed, healthy individuals who are not on drugs or psychotropic medications and have no chronic medical, psychiatric, or neurological illnesses. Women cannot be pregnant or nursing. Participants must also be comfortable with MRI scans and free from claustrophobia.

Inclusion Criteria

Must be healthy (without medical, neurological, psychiatric illness)

Must be psychotropic medication free (≥ 14 days)

Must be illicit drug-free at the time of scanning as appropriate (verified by negative urine drug screen)

Exclusion Criteria

Must not have ongoing, chronic, or relapsing/remitting medical, psychiatric,or neurological illness as determined by a combination of history, medical record, and/or examination.

Females must not be pregnant or nursing

You cannot be claustrophobic.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low-intensity focused ultrasound pulsation (LIFUP) neuromodulation targeting the amygdala to study emotion processing

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LIFUP sonication

Trial Overview The study is testing the effects of a technique called LIFUP sonication to the amygdala on emotion processing in healthy people. It aims to understand how this low-intensity focused ultrasound can stimulate or inhibit brain activity safely.

How Is the Trial Designed?

Group I: LIFUP sonication to the amygdala Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

Low intensity focused ultrasound (LIFU) is a promising non-invasive technology that can precisely modulate brain activity, offering a new approach to studying and potentially treating psychiatric illnesses.

LIFU has been shown to safely affect both cortical and subcortical brain regions, distinguishing it from other neuromodulatory techniques due to its spatial precision and reversible effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low Intensity Focused Ultrasound for Non-invasive and Reversible Deep Brain Neuromodulation-A Paradigm Shift in Psychiatric Research. Arulpragasam, AR., van 't Wout-Frank, M., Barredo, J., et al.[2022]

A study involving 120 participants evaluated the safety of low intensity transcranial focused ultrasound (LIFU) for neuromodulation, finding no serious adverse effects and only mild to moderate symptoms reported by 7 participants, which were generally transient.

The symptom profile from LIFU was similar to other non-invasive brain stimulation methods, suggesting that LIFU is a safe option for neuromodulation with manageable side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective qualitative report of symptoms and safety from transcranial focused ultrasound for neuromodulation in humans. Legon, W., Adams, S., Bansal, P., et al.[2021]

Low-intensity focused ultrasound (LIFUS) is a promising noninvasive technique that can modulate human brain activity, showing effects like suppressing cortical evoked potentials and altering sensory/motor task outcomes in studies involving human subjects.

The proposed mechanisms of LIFUS include cavitation and direct effects on neural ion channels, suggesting it could be developed for non-surgical treatments of neurological disorders, although optimal protocols are still being refined.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-intensity ultrasound neuromodulation: An overview of mechanisms and emerging human applications. Fomenko, A., Neudorfer, C., Dallapiazza, RF., et al.[2019]

High-density gel polymer matrices are effective couplants for low-intensity focused ultrasound (LIFU) neuromodulation, showing low acoustic attenuation (3.3%) and minimal beam distortion, making them suitable for clinical use.

The study highlights the importance of using standardized methods for preparing these gels to ensure consistent performance, as factors like thickness and de-gassing can significantly affect acoustic transmission and pressure attenuation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Novel Acoustic Coupling Medium for Human Low-Intensity Focused Ultrasound Neuromodulation Applications. Strohman, A., In, A., Stebbins, K., et al.[2023]

In a study involving 12 healthy participants, transcranial pulse stimulation (TPS) was shown to significantly enhance the efficiency of the cortical sensorimotor network and improve axonal status in the stimulated area, indicating positive neuroplastic changes.

The effects of TPS were observed to last up to one week after stimulation, suggesting its potential for long-term benefits in treating neurological and psychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First evidence of long-term effects of transcranial pulse stimulation (TPS) on the human brain. Matt, E., Kaindl, L., Tenk, S., et al.[2022]

A prototype Low Intensity Focused Ultrasound (LIFU) stimulator was successfully developed and tested on a Göttingen minipig, showing its potential for non-invasive neuromodulation.

The study demonstrated that targeted stimulation of the hypothalamus using LIFU resulted in reversible increases in heart rate and blood pressure, indicating a direct physiological effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prototype stimulator system for noninvasive Low Intensity Focused Ultrasound delivery. Mulgaonkar, AP., Singh, RS., Babakhanian, M., et al.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12162705/

Low-intensity transcranial focused ultrasound of the amygdala ... Our results indicate that LIFU of the amygdala acutely dampens amygdala reactivity during active socio-emotional processing.

2. nature.com nature.com/articles/s41380-025-03033-w

Low-intensity transcranial focused ultrasound amygdala ... There were significant reductions on the primary outcome (Mood and Anxiety Symptom Questionnaire General Distress subscale; p = 0.001, Cohen's d ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03782194

Low Intensity Focused Ultrasound for Learning and ... The goal of this clinical trial is to investigate the impact of low intensity focused ultrasound pulsation (LIFUP) to two different brain regions.

4. fusfoundation.org fusfoundation.org/posts/clinical-trial-results-focused-ultrasound-neuromodulation-improves-mood-anxiety-and-trauma-related-disorders/

Clinical Trial Results The researchers successfully targeted the left amygdala, which is known to be hyperactive in mood and anxiety disorders. The results from the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9081930/

Current State of Potential Mechanisms Supporting Low ... Low intensity focused ultrasound (LIFU) has been gaining traction as a non-invasive neuromodulation technology due to its superior spatial specificity relative ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715914600672

Low-Intensity Focused Ultrasound Pulsation Device Used ... LIFUP utilizes low-energy ultrasound (US) waves that pass through the skin and skull without surgery and which can be focused almost anywhere in the brain to ...