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RecruitingNCT07404878Updated Oct 29, 2026

VITAL - Virginia Tech Accelerated Holographic LIFU for Anxiety

An interventional study of Low-Intensity Focused Ultrasound and Sham LIFU in Anxiety, sponsored by Virginia Polytechnic Institute and State University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Virginia Polytechnic Institute and State University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.
Updated Oct 29, 2026Now RecruitingFirst site in United States+8 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed description

This is a cross-over design with Real and Sham LIFU application with multiple weeks of follow-up. Follow-up includes anxiety metrics and mri scanning. LIFU application will be done using custom individual holograms to lens the waveform. Repeated applications of LIFU will be utilized. The NPU anxiety task will be utilized pre/post LIFU to assess outcomes. Questionnaires will be administered at each study visit.

02

Conditions studied

  • Anxiety

Browse trials for

03

In context

Anxiety Disorders Unverified

7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's planned enrollment of 80 is close to the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Virginia Polytechnic Institute and State University is the lead sponsor of 127 studies on the registry; 28 are open to participants now.

Browse Virginia Polytechnic Institute and State University studies →

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Claustrophobia
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Low-intensity LIFU

    Low intensity application of Low-intensity focused ultrasound

    Device: Low-Intensity Focused Ultrasound · Device: Sham LIFU

  • Experimental
    High Intensity LIFU

    High intensity application of low-intensity focused ultrasound

    Device: Low-Intensity Focused Ultrasound · Device: Sham LIFU

Interventions

  • DeviceLow-Intensity Focused Ultrasound

    low-intensity focused ultrasound

  • DeviceSham LIFU

    Sham application of Low-intensity focused ultrasound

06

What researchers measure

Primary outcomes

  1. Heart-beat evoked potential (HEP)

    HEP derived from ECG signal will be analyzed pre/post LIFU (or sham).

    Time frame: within study session - over approximately 4 hours.

  2. Electromyography (EMG)

    EMG (muscles surrounding the eye) response to startle probes (using the NPU anxiety task)

    Time frame: pre/post intervention (LIFU/Sham) [4 hours] as well as during follow-up visits [at week 2 and week 4 post intervention]

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for May 2028, 26 months after the start.

Of 3,836 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 26 months is above that.

Counting every sponsor, half of 3,938 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2026
First posted
Feb 12, 2026
StartActual
Mar 9, 2026
Primary completionEst.
May 2028
CompletionEst.
Dec 2028
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Withheld→Recruiting
changed Oct 29, 2026
Sites
1 site added — first site in United States
Show site
  • Fralin Biomedical Research Institute at VTC · Roanoke, United States
Oct 29, 2026
Start date
Set to Mar 9, 2026 (actual)
Oct 29, 2026
Primary completion
Set to May 2028
Oct 29, 2026
Study completion
Set to Dec 2028
Oct 29, 2026
Eligibility
Revised
Oct 29, 2026
Interventions
Arms or interventions changed
Oct 29, 2026
Title
[Trial of device that is not approved or cleared by the U.S. FDA]→VITAL - Virginia Tech Accelerated Holographic LIFU for Anxiety
Oct 29, 2026
Sponsor
[Redacted]→Virginia Polytechnic Institute and State University
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Withheld→Recruiting
    1 site added — first site in United States
    Show site
    • Fralin Biomedical Research Institute at VTC · Roanoke, United States
    Start date Set to Mar 9, 2026 (now actual)
    Primary completion Set to May 2028
    Study completion Set to Dec 2028
    Eligibility Revised
    Interventions Arms or interventions changed
    Sponsor [Redacted]→Virginia Polytechnic Institute and State University
    Title [Trial of device that is not approved or cleared by the U.S. FDA]→VITAL - Virginia Tech Accelerated Holographic LIFU for Anxiety
    + 9 other changes: index terms, registry dates, verification date, oversight details, description, conditions, design details, secondary outcomes and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07404878
Lead sponsor
Virginia Polytechnic Institute and State University
Responsible party
Wynn Legon (Assistant Professor, Virginia Polytechnic Institute and State University) — Principal investigator
First posted
Feb 12, 2026
Start date
Mar 9, 2026
Primary completion
May 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Oct 29, 2026

Study contacts

Jessica Research Associate, MPH
Contact
jnw@vtc.vt.edu
540-526-2261

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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