LIFU for Anxiety Management

Virginia Polytechnic Institute and State University

Status: Active, not recruiting

Conditions: Anxiety

Treatments: Device: Low-intensity focused ultrasound - sham; Device: Low-intensity focused ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT05839847

23-192

Details and patient eligibility

About

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).

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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44 participants in 2 patient groups

NPU

Experimental group

Description:

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.

Treatment:

Device: Low-intensity focused ultrasound

Device: Low-intensity focused ultrasound - sham

NPU-c

Experimental group

Description:

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.

Treatment:

Device: Low-intensity focused ultrasound

Device: Low-intensity focused ultrasound - sham