AnxietyNCT07404878
VITAL - Virginia Tech Accelerated Holographic LIFU for Anxiety
A study testing Low-Intensity Focused Ultrasound in people with Anxiety, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
Testing repeated applications of low-intensity focused ultrasound (LIFU) on anxiety symptoms and outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Low-Intensity Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with generalized anxiety disorder (GAD) symptoms; defined by a GAD-7 score >= 10, OASIS score >= 8, or a PSWQ score >= 45.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24016
Jessica Research Associate, MPH, 540-526-2261, jnw@vtc.vt.edu
About this study
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.
- Conditions
- Anxiety
- Being tested
- Low-Intensity Focused Ultrasound, Sham LIFU
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Focused UltrasoundDevice
low-intensity focused ultrasound
Sham LIFUDevice
Sham application of Low-intensity focused ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Low-intensity LIFU | Experimental | Low intensity application of Low-intensity focused ultrasound Receives: Device: Low-Intensity Focused Ultrasound; Device: Sham LIFU |
| High Intensity LIFU | Experimental | High intensity application of low-intensity focused ultrasound Receives: Device: Low-Intensity Focused Ultrasound; Device: Sham LIFU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart-beat evoked potential (HEP)
HEP derived from ECG signal will be analyzed pre/post LIFU (or sham).
Measured: within study session - over approximately 4 hours.
Electromyography (EMG)
EMG (muscles surrounding the eye) response to startle probes (using the NPU anxiety task)
Measured: pre/post intervention (LIFU/Sham) [4 hours] as well as during follow-up visits [at week 2 and week 4 post intervention]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start9 Mar 2026
- Primary completionMay 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Study involves parallel groups (Low vs High intensity LIFU) with a cross-over design of Real and Sham within each intensity group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wynn Legon, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404878
- Sponsor's protocol ID
- 25-1284
- Status last verified
- Oct 2026
- First submitted
- 4 Feb 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VITAL - Virginia Tech Accelerated Holographic LIFU for Anxiety
- ClinicalTrials.gov ID
- NCT07404878
- Acronym / sponsor ID
- 25-1284
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Testing repeated applications of low-intensity focused ultrasound (LIFU) on anxiety symptoms and outcomes.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Study involves parallel groups (Low vs High intensity LIFU) with a cross-over design of Real and Sham within each intensity group.
| Arm | Type | Receives |
|---|---|---|
| Low-intensity LIFU | Experimental | Device: Low-Intensity Focused Ultrasound, Device: Sham LIFULow intensity application of Low-intensity focused ultrasound |
| High Intensity LIFU | Experimental | Device: Low-Intensity Focused Ultrasound, Device: Sham LIFUHigh intensity application of low-intensity focused ultrasound |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with generalized anxiety disorder (GAD) symptoms; defined by a GAD-7 score >= 10, OASIS score >= 8, or a PSWQ score >= 45.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Intensity Focused Ultrasoundlow-intensity focused ultrasound | Device | High Intensity LIFU, Low-intensity LIFU |
| Sham LIFUSham application of Low-intensity focused ultrasound | Device | High Intensity LIFU, Low-intensity LIFU |
Primary outcome
Heart-beat evoked potential (HEP)
Time frame: within study session - over approximately 4 hours.
HEP derived from ECG signal will be analyzed pre/post LIFU (or sham).
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]
EMG (muscles surrounding the eye) response to startle probes (using the NPU anxiety task)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Intensity Focused Ultrasound in people with Anxiety, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Research Associate, MPH (540-526-2261, jnw@vtc.vt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart-beat evoked potential (HEP) (time frame: within study session - over approximately 4 hours.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.