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Not yet recruitingNCT07686354Updated Sep 11, 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. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

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

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

Who can participate

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

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
  • Contraindications 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
04

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.

05

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.

06

Study locations

1 site
  • Fralin Biomedical Research Institute at VTC
    Roanoke, Virginia 24016, United States
    • Jessica Research Associate, MPH · Contact · jnw@vtc.vt.edu · 5405262261
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07686354
Lead sponsor
Virginia Polytechnic Institute and State University
Responsible party
Wynn Legon (Assistant Professor, Virginia Polytechnic Institute and State University) — Principal investigator
First posted
Jul 7, 2026
Start date
Oct 2026 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 11, 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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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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