Holographic Low-Intensity Focused Ultrasound for Anxiety
Official title: VITAL - Virginia Tech Accelerated Holographic LIFU for Anxiety
Run by Virginia Polytechnic Institute and State University · NCT07404878 · Data updated 2026-11-12
This study tests whether applying repeated, personalized holographic low-intensity focused ultrasound can help reduce anxiety symptoms in adults with generalized anxiety disorder.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Virginia Polytechnic Institute and State University Academic / other |
| Locations | 1 site (Roanoke, Virginia) |
| Status | Recruiting |
| Started | March 9, 2026 |
| Main results expected | May 2028 |
| Study ends | December 2028 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07404878 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with generalized anxiety disorder or significant anxiety symptoms (GAD-7 >= 10, OASIS >= 8, or PSWQ >= 45) who can undergo MRI and comply with study visits.
✕Probably not a fit
Individuals with claustrophobia, MRI/CT contraindications, active CNS disorders, history of neurological disease or head injury, or active substance dependence may not benefit or participate.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial uses a cross-over design to compare real versus sham LIFU sessions, with multiple weeks of follow-up that include MRI scans and anxiety assessments. A custom hologram-based approach lenses the ultrasound waveform to target brain regions. Pre- and post-stimulation anxiety measurements are collected using the NPU task and standard questionnaires at each visit. The study aims to determine if repeated, patient-specific LIFU treatment can produce measurable improvements in anxiety-related outcomes compared with sham stimulation.
Why it matters
Potential benefit: If successful, participants may experience reduced anxiety symptoms and better overall function after repeated LIFU treatments.
How similar studies have gone: Prior work with focused ultrasound and brain stimulation approaches has shown potential in mood and anxiety-related outcomes, but this holographic LIFU approach is novel in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, United States Recruiting
Study contacts
- Study coordinator: Jessica Research Associate, MPH
- Email: jnw@vtc.vt.edu
- Phone: 540-526-2261
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.