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Active, Not Recruiting

NCT Number: NCT05839847

LIFU for Anxiety Management

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Low-intensity focused ultrasound - sham

Device

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

Primary outcomes

  1. Change in EMG eye startle reflex

    Time frame: Through study completion, an average of 2 weeks

    Attenuated amplitude of startle reflex during uncertain and predictable threat tasks with lifu compared to sham.

  2. Change in heart rate using ECG

    Time frame: Through study completion, an average of 2 weeks

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

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Registry information

Official study title

Investigation of Low-intensity Focused Ultrasound for Human Anxiety Management

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
May 3, 2023
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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