LIFU for Anxiety Management

Anxiety Clinical Trial

Official title:

Investigation of Low-intensity Focused Ultrasound for Human Anxiety Management

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05839847
• Other study ID #: 23-192
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: April 1, 2026

Study information

• Verified date: February 2024
• Source: Virginia Polytechnic Institute and State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 160
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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.
• Low-intensity focused ultrasound - sham
A sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain.

Locations

Country	Name	City	State
United States	Fralin Biomedical Research Institute at VTC	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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