LIFU for Anxiety Management

Not Applicable

Active, not recruiting

• Conditions: Anxiety

• Registration Number: NCT05839847
• Lead Sponsor: Virginia Polytechnic Institute and State University

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).

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 Timeline

• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-04-20
• Study First Posted: 2023-05-03
• Study Start: 2023-12-20
• Primary Completion: 2025-02-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Trial Locations

Locations (1)

Fralin Biomedical Research Institute at VTC; 🇺🇸 Roanoke, Virginia, United States