LIFU for Anxiety Management

April 9, 2026 updated by: Wynn Legon, Virginia Polytechnic Institute and State University

Investigation of Low-intensity Focused Ultrasound for Human Anxiety Management

This study is examining the effects of noninvasive brain stimulation on anxiety. Low-intensity focused ultrasound (LIFU) will be utilized to neuromodulate the brain prior to a task (NPU). Physiological recordings will be taken throughout (EEG, EMG, HR, BP, RR, GSR).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a research project examining the effects of noninvasive brain stimulation on anxiety. This study will help us to better understand possible treatments for patients diagnosed with anxiety disorders. Participants will undergo a functional magnetic resonance imaging (fMRI) and a computed tomography (CT) scan, to image the bone and brain tissue. Participants will receive noninvasive brain stimulation using low-intensity focused ultrasound (LIFU) sound waves, to temporarily change brain activity. Participants will undergo a threat task involving brief (100ms) shocks (1-5mA) and startle noises. Brain signals (EEG), muscle twitch (EMG), heart rate and rhythm, blood pressure, respiration rate, and skin moisture will be monitored throughout. Participants will be asked to complete behavioral questionnaires.

Study Type

Interventional

Enrollment (Actual)

44

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
    • Virginia
      • Roanoke, Virginia, United States, 24016
        • Fralin Biomedical Research Institute at VTC

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • High or low trait anxiety

Exclusion Criteria:

  • claustrophobia
  • Contraindications to MRI (implants)
  • Contraindications to CT (pregnancy)
  • Active medical disorder with CNS effects (e.g. Alzheimers)
  • History of neurologic disorder (e.g. Parkinson's, epilepsy)
  • History of head injury w/ LOC for >10 min
  • History of alcohol or drug dependence
  • History of current cardiovascular disease

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NPU
Participant will be presented with a series of images (cues) and sounds. Three conditions will occur - a no shock (N), predictable shock (P), and unpredictable shock (U). In P, shocks will only occur with the cue. In U, shocks will happen at any time. Participants will be told which condition they are in throughout the task. Startle sounds will occur throughout. 3 Study visits will occur - identical conditions for the participant, testing 2 brain regions and 1 sham visit.
Device: Low-intensity focused ultrasound
A noninvasive brain stimulation device using low-intensity focused ultrasound (LIFU) - ultrasound will be used to test whether noninvasive brain stimulation can reduce reactions to sensory stimuli.
Device: Low-intensity focused ultrasound - sham
A sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain.
Experimental: NPU-c
Participants will be presented with a moving line. When the line reaches a certain point - an event will occur. This event will either be a painful shock or a monetary reward. Startle sounds will occur throughout. 3 study visits will occur - identical conditions for the participant, testing 2 brain regions and 1 sham visit.
Device: Low-intensity focused ultrasound
A noninvasive brain stimulation device using low-intensity focused ultrasound (LIFU) - ultrasound will be used to test whether noninvasive brain stimulation can reduce reactions to sensory stimuli.
Device: Low-intensity focused ultrasound - sham
A sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in EMG eye startle reflex
Time Frame: Through study completion, an average of 2 weeks
Attenuated amplitude of startle reflex during uncertain and predictable threat tasks with lifu compared to sham.
Through study completion, an average of 2 weeks
Change in heart rate using ECG
Time Frame: Through study completion, an average of 2 weeks
Attenuation of hear rate increases due to startle tasks in lifu compared to sham condition
Through study completion, an average of 2 weeks

Collaborators and Investigators

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

Sponsor

Virginia Polytechnic Institute and State University

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 (Actual)

December 20, 2023

Primary Completion (Actual)

February 26, 2025

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-192

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

No

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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