Recruiting

LIFU

Sponsor:

Virginia Polytechnic Institute and State University

Code:

NCT07404878

Conditions

Anxiety

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Low-Intensity Focused Ultrasound

Sham LIFU

Study Details

Brief summary:

Testing repeated applications of low-intensity focused ultrasound (LIFU) on anxiety symptoms and outcomes.

Conditions

Anxiety

Study ID

NCT07404878

Start date

Mar 9, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with generalized anxiety disorder (GAD) symptoms; defined by a GAD-7 score >= 10, OASIS score >= 8, or a PSWQ score >= 45.

Exclusion Criteria:

  • Claustrophobia
  • Contraindications to MRI (certain implants or metal in the body)
  • Contraindications to CT (pregnancy)
  • Active medical disorder with CNS effects (e.g. Alzheimer's)
  • History of neurological disorder
  • History of head injury
  • Active alcohol or drug dependence

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Low-intensity LIFU

Low intensity application of Low-intensity focused ultrasound

experimental: High Intensity LIFU

High intensity application of low-intensity focused ultrasound

Interventions

Low-Intensity Focused Ultrasound

low-intensity focused ultrasound

Sham LIFU

Sham application of Low-intensity focused ultrasound

Primary outcome measure

  • Heart-beat evoked potential (HEP) [ Time Frame: within study session - over approximately 4 hours. ]
  • Electromyography (EMG) [ Time Frame: pre/post intervention (LIFU/Sham) [4 hours] as well as during follow-up visits [at week 2 and week 4 post intervention] ]

Central Contacts and Locations

Central contacts

Jessica Research Associate, MPH

540-526-2261jnw@vtc.vt.edu

Locations

Fralin Biomedical Research Institute at VTC

Recruiting

Roanoke, Virginia, United States, 24016

Contacts

Jessica Research Associate, MPH

540-526-2261jnw@vtc.vt.edu

More Information

Sponsor

Virginia Polytechnic Institute and State University

Last update posted

Oct 29, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-30. This information was provided to ClinicalTrials.gov by Virginia Polytechnic Institute and State University on 2026-10-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.