LIFU for Anxiety Management

NCT05839847 | Active Not Recruiting

• 1 other identifier: 23-192
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Anxiety

Outcome Measures

Primary Outcomes (2)

• Change in EMG eye startle reflex

  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

  Attenuation of hear rate increases due to startle tasks in lifu compared to sham condition

  Through study completion, an average of 2 weeks

Study Arms (2)

NPU

EXPERIMENTAL

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; Device: Low-intensity focused ultrasound - sham

NPU-c

EXPERIMENTAL

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; Device: Low-intensity focused ultrasound - sham

Interventions

Low-intensity focused ultrasound - sham DEVICE

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

NPU; NPU-c

Low-intensity focused ultrasound 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.

NPU; NPU-c

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• High or low trait anxiety

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: May 3, 2023
• Study Start: December 20, 2023
• Primary Completion: February 26, 2025
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)