LIFU for Anxiety Management

Sponsor

Virginia Polytechnic Institute and State University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05839847

Collaborator

(none)

160

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Device: Low-intensity focused ultrasound Device: Low-intensity focused ultrasound - sham	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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.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.

Masking:

Single (Participant)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Investigation of Low-intensity Focused Ultrasound for Human Anxiety Management

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Apr 1, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Virginia Polytechnic Institute and State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wynn Legon, Assistant Professor, Virginia Polytechnic Institute and State University

ClinicalTrials.gov Identifier:

NCT05839847

Other Study ID Numbers:

23-192

First Posted:

May 3, 2023

Last Update Posted:

May 6, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of May 6, 2023