LIFU for Anxiety Management

NCT ID: NCT05839847

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-20

Study Completion Date

2026-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will act as their own sham - sham vs real will be conducted in separate study visits. 2 arms exist for 2 variations of the NPU task.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participant will experience the same setup in real and sham conditions. The gel puck used to couple the ultrasound signal will either have a blocking disk, or no blocking disk to either allow or block the ultrasound signal.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Low-intensity focused ultrasound

Intervention Type DEVICE

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.

Low-intensity focused ultrasound - sham

Intervention Type DEVICE

A sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain.

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.

Group Type EXPERIMENTAL

Low-intensity focused ultrasound

Intervention Type DEVICE

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.

Low-intensity focused ultrasound - sham

Intervention Type DEVICE

A sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Low-intensity focused ultrasound - sham

A sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wynn Legon

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

23-192

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.