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Low-Intensity Focused Ultrasound for Brain Modulation

This study is looking at how different doses of low-intensity focused ultrasound (LIFU) affect the brain. LIFU is a way to change the activity of deep brain areas without surgery, and it can be reversed. Researchers want to understand how different strengths and durations of LIFU impact the brain's white matter (the connections between different brain parts). You might be able to join if you are a healthy adult between 18 and 65 years old, have a healthy weight, and speak English fluently. The study hopes to find out how LIFU doses change brain activity, which could help in future studies for mental health conditions. The current status of this study is unclear.

Study design
This interventional study plans to enroll 66 healthy participants. It will look at how a single dose or multiple doses of low-intensity focused ultrasound (LIFU) affect brain tissue.
What's involved
The study involves receiving a single 80-second LIFU stimulus or multiple doses. Researchers will measure changes in your brain tissue before and up to 30 minutes after the LIFU application.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure changes up to 30 minutes after the low-intensity focused ultrasound (LIFU) application.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07099950

Dose-Dependent Effects of Low-Intensity Focused Ultrasound

Recruiting
NAAges 18–65InterventionalBasic science
Laureate Institute for Brain Research, Inc.
~66 participants
Updated 2025-10-16 on ClinicalTrials.gov
What's tested:Low-intensity focused ultrasound

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Post-Sonication Changes in Tissue Engagement
Measured over Pre- vs up to 30 minutes post-sonication for 1-epoch vs 3-epoch LIFU.

Conditions

Healthy Controls

Explore related trials

Healthy

Where it's being run

1 sites across 1 states
Oklahoma1

Who to contact

Salvador M Guinjoan, MD, PhD
[email protected]
918-502-5119
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 18 to 65 years.
Body mass index 17-38 kg/m2.
Fluent English speaker, capable of providing written informed consent.
Overall Anxiety Severity and Impairment Scale \<8 and Patient Health Questionnaire-9 \<10
A person of childbearing potential must have a negative urine pregnancy test at screening
Consent that random observations of pathology are possible (e.g., brain abnormality seen during imaging).

Exclusion

Inability to provide informed consent including medical, psychiatric, or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or complete the study.
No telephone or easy access to telephone
Has active suicidal ideation (as measured by Suicide-Risk-Assessment-C-SSRS "Yes" answers to items 3, 4, or 5 Suicidal Ideation-Past 1 month section, or any "Yes" answer to any of the items of Suicidal Behavior-Past 3 months section), or any suicide attempt in the last 3 months
Has positive test result(s) for alcohol of abuse (including methadone, opiates, cocaine, amphetamine/methamphetamine and ecstasy), or substance use disorder including alcohol, stimulants, sedatives, and cannabis exceeding mild severity in the last 6 months
Has a lifetime APA Diagnostic and Statistical Manual of Mental Disorders (DSM)-5th edition including major depression, generalized anxiety disorder, specific phobias, panic disorder, post-traumatic stress disorder, schizophrenia spectrum and other psychotic disorders, obsessive-compulsive disorder, or bipolar disorder.
Benzodiazepines or anticonvulsants in the 7 days prior to participation.
MRI contradictions as detected by the MRI Safety Screen including claustrophobia and unwillingness and inability to complete scans (e.g., unable to lie on one's back for 60 mins.
Clinical history of relevant structural pathology of the central nervous system, including Parkinson's disease, multiple sclerosis, and brain malignant neoplasia.
History of unstable liver or renal insufficiency; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, hematological, rheumatological, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit or confound the protocol-specified assessments, including uncontrolled diabetes mellitus (ss evidenced by fasting glycemia ≥ 120 mg/dL or hemoglobin A1c ≥ 6.5%) or hypertension (as evidenced by two consecutive readings ≥ 140/90 mmHg) to ensure medical stability throughout this longitudinal study.
Moderate-to-severe traumatic brain injury or any other clinical neurocognitive disorder.
Clinical history of at least minor neurocognitive disorder of any origin.
Prescription of a medication outside of the accepted range, as determined by best clinical practices and current research.
Use of any psychotropic medication.
Unwillingness or inability to complete any major aspects of the study protocol.
Prior neurosurgery.
Non-correctable vision or hearing.

What this trial measures

  • Post-Sonication Changes in Tissue EngagementPre- vs up to 30 minutes post-sonication for 1-epoch vs 3-epoch LIFU.

    Changes in resting-state functional (fMRI) connectivity (FC) between thalamus and both subgenual (sgCC) and orbitofrontal (OFC) cortices after one vs. after three-epoch LIFU.