Transcranial Low Intensity Focused Ultrasound Neuromodulation as a Probe to Study Human Emotion and Cognitive Function

The University of Texas Health Science Center, Houston1 site in 1 country24 target enrollmentJanuary 1, 2026

ConditionsDepressive Disorder, Major

InterventionsLIFUP sonication to the amygdala

Overview

Phase: Not Applicable
Intervention: LIFUP sonication to the amygdala
Conditions: Depressive Disorder, Major
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 24
Locations: 1
Primary Endpoint: Changes in amygdala activity indicated by functional magnetic resonance imaging (fMRI) scan blood oxygen-level-dependent (BOLD) signal
Status: Withdrawn
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2026

End Date

January 1, 2028

Last Updated

2 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Jair Soares

Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

•Must be right-handed
•Must be illicit drug-free at the time of scanning as appropriate (verified by negative urine drug screen)
•Must be healthy (without medical, neurological, psychiatric illness)
•Must be psychotropic medication free (≥ 14 days)

Exclusion Criteria

•Must not be a smoker
•Females must not be pregnant or nursing
•Must not suffer from claustrophobia
•Must not meet exclusion criteria for MRI scanning (i.e., non-fixed magnetizable objects)
•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.

Arms & Interventions

LIFUP sonication to the amygdala

Intervention: LIFUP sonication to the amygdala

Outcomes

Primary Outcomes

Changes in amygdala activity indicated by functional magnetic resonance imaging (fMRI) scan blood oxygen-level-dependent (BOLD) signal

Time Frame: baseline, 5 mins post-LIFUP sonication

Changes in brain resting state functional network as indicated by fMRI scan connectivity measures

Time Frame: baseline, 10-20 mins post-LIFUP sonication

Secondary Outcomes

Change in performance on Reward Task(baseline, 1-hour post-LIFUP sonication)
Tolerability of LIFUP sonication as assessed number of adverse events(baseline, immediately after LIFUP sonication)