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

February 10, 2026 updated by: Jair Soares, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LIFUP sonication to the amygdala
Device: LIFUP sonication to the amygdala
LIFUP sonication to amygdala will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
baseline, 10-20 mins post-LIFUP sonication

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in performance on Reward Task
Time Frame: baseline, 1-hour post-LIFUP sonication
baseline, 1-hour post-LIFUP sonication
Tolerability of LIFUP sonication as assessed number of adverse events
Time Frame: baseline, immediately after LIFUP sonication
baseline, immediately after LIFUP sonication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Jair Soares, MD, PhD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 3, 2022

First Submitted That Met QC Criteria

January 3, 2022

First Posted (Actual)

January 18, 2022

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-21-0570

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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