ClinicalTrials.gg
RecruitingNCT07686354Updated Nov 9, 2026

LIFU for Chronic Pain and Generalized Anxiety Disorder

An interventional study of Low Intensity Focused Ultrasound in Chronic Pain and Generalized Anxiety Disorder, 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 2026-11-09.

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

Updated Nov 9, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

A proof of concept case study to investigate accelerated LIFU protocol in chronic pain and anxiety populations.

Read the detailed description

A single-arm, open label, 2 cohort (chronic pain/GAD) case study with extended (6 months) follow-up following accelerated low-intensity focused ultrasound for neuromodulation.

02

Conditions studied

  • Chronic Pain
  • Generalized Anxiety Disorder
03

In context

Chronic Pain

3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.

This study's planned enrollment of 10 is below the median of 60 across 2,388 interventional studies indexed under Chronic Pain.

Browse Chronic Pain 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.

Counted across the registry records on this site, refreshed daily.

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

  • GAD Symptoms - GAD-7 score >= 10, OASIS score >= 8, or PSWQ score >= 45. OR Chronic pain symptoms - moderate to severe pain, present for at least 3 months.

Exclusion criteria

Exclusion Criteria:

  • Claustrophobia
  • to MRI or CT
  • Active medical disorder with CNS effects
  • History of neurologic disorder
  • History of head injury with LOC > 10 minutes
  • Active drug or alcohol 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Low-intensity focused ultrasound for neuromodulation

    Accelerated (repeat) LIFU application for neuromodulation

    Device: Low Intensity Focused Ultrasound

Interventions

  • DeviceLow Intensity Focused Ultrasound

    Low-Intensity Focused Ultrasound applied multiple times in a single study visit.

06

What researchers measure

Primary outcomes

  1. Safety - monitoring of possible symptoms

    Symptom monitoring before and after LIFU applications and throughout 6 months of follow-up. Each symptom is presented with a likert scale (absent, mild, moderate, severe) - along with a free response option for any symptoms not included in the list.

    Time frame: Throughout study participation at multiple time points, approximately 6 months.

  2. Changes in Chronic Pain - self report

    Participants will complete the Brief Pain Inventory (BPI) at multiple time points throughout the 6 month period. This questionnaire asks participants to rate their pain on a 10 point scale (10 being the most pain).

    Time frame: Multiple timepoints throughout the 6 month experimental timeframe.

  3. Changes in Anxiety - self report

    Participants will complete the Beck Anxiety Inventory (BAI) at multiple time points before and after LIFU application to track changes in anxiety throughout the 6 month timeframe. The BAI probes different symptoms of anxiety and participants rate it on a likert scale (not at all, mildly, moderately, or severely).

    Time frame: Throughout the experimental timeframe, approximately 6 months.

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

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Nov 9, 2026
Sites
Fralin Biomedical Research Institute at VTC is now Recruiting
Nov 9, 2026
Start date
Oct 2026→Dec 2026
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    Not yet recruiting→Recruiting
    Fralin Biomedical Research Institute at VTC is now Recruiting
    Start date Oct 2026→Dec 2026
    + 1 other change: verification date

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
NCT07686354
Responsible party
Wynn Legon (Assistant Professor, Virginia Polytechnic Institute and State University) — Principal investigator
First posted
Jul 7, 2026
Start date
Dec 2026 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Nov 9, 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
No
View the source record on ClinicalTrials.gov ↗

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