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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the low-intensity focused ultrasound pulsation (LIFUP) neuromodulation on emotion processing in healthy individuals, and to assess the overall safety of the LIFUP to stimulate or inhibit brain activity in healthy volunteers.

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 data supports the effectiveness of the treatment LIFUP sonication in the clinical trial LIFUP Neuromodulation for Healthy Controls?

Research shows that low intensity focused ultrasound (LIFU) can safely and precisely modulate brain activity, offering a non-invasive way to study and potentially treat brain conditions. It has been shown to affect brain activity in both humans and animals, suggesting it could be a promising tool for neuromodulation. ^{1 2 3 4 5}

Is LIFUP neuromodulation safe for humans?

Studies show that LIFUP (also known as low intensity focused ultrasound) is generally safe for humans, with no serious side effects reported. Some participants experienced mild symptoms like neck pain, attention problems, and muscle twitches, but these were not severe and often went away quickly. ^{1 5 6 7 8}

How does LIFUP sonication treatment differ from other treatments for brain neuromodulation?

LIFUP sonication is unique because it uses low-intensity focused ultrasound to non-invasively and precisely target deep brain areas, unlike other methods like transcranial magnetic stimulation or deep brain stimulation, which are either less precise or more invasive. This treatment is also reversible, allowing for safe modulation of brain activity without permanent changes. ^{1 6 9 10 11}

Research Team

Jair C Soares, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Low Intensity Focused Ultrasound for Non-invasive and Reversible Deep Brain Neuromodulation-A Paradigm Shift in Psychiatric Research. [2022]

2. England pubmed.ncbi.nlm.nih.gov

First evidence of long-term effects of transcranial pulse stimulation (TPS) on the human brain. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Ultrasound Neuromodulation: A Review of Results, Mechanisms and Safety. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A review of low-intensity focused ultrasound pulsation. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A prototype stimulator system for noninvasive Low Intensity Focused Ultrasound delivery. [2016]

6. England pubmed.ncbi.nlm.nih.gov

A retrospective qualitative report of symptoms and safety from transcranial focused ultrasound for neuromodulation in humans. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Implication of auditory confounding in interpreting somatosensory and motor responses in low-intensity focused transcranial ultrasound stimulation. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Low-intensity ultrasound neuromodulation: An overview of mechanisms and emerging human applications. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Design, Development, and Operation of a Low-Intensity Focused Ultrasound Pulsation (LIFUP) System for Clinical Use. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Non-genetic photoacoustic stimulation of single neurons by a tapered fiber optoacoustic emitter. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Evaluation of a Novel Acoustic Coupling Medium for Human Low-Intensity Focused Ultrasound Neuromodulation Applications. [2023]