Recruiting

Accelerated LIFU

Sponsor:

Virginia Polytechnic Institute and State University

Code:

NCT07686354

Conditions

Chronic Pain

Generalized Anxiety Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Low Intensity Focused Ultrasound

Study Details

Brief summary:

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

Conditions

Chronic Pain

Generalized Anxiety Disorder

Study ID

NCT07686354

Start date

Dec, 2026

Status verified date

Nov, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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:

  • 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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Low-intensity focused ultrasound for neuromodulation

Accelerated (repeat) LIFU application for neuromodulation

Interventions

Low Intensity Focused Ultrasound

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

Primary outcome measure

  • Safety - monitoring of possible symptoms [ Time Frame: Throughout study participation at multiple time points, approximately 6 months. ]
  • Changes in Chronic Pain - self report [ Time Frame: Multiple timepoints throughout the 6 month experimental timeframe. ]
  • Changes in Anxiety - self report [ Time Frame: Throughout the experimental timeframe, approximately 6 months. ]

Central Contacts and Locations

Central contacts

Jessica Research Associate, MPH

540-526-2261jnw@vtc.vt.edu

Locations

Fralin Biomedical Research Institute at VTC

Recruiting

Roanoke, Virginia, United States, 24016

Contacts

Jessica Research Associate, MPH

5405262261jnw@vtc.vt.edu

More Information

Sponsor

Virginia Polytechnic Institute and State University

Last update posted

Nov 9, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-10. This information was provided to ClinicalTrials.gov by Virginia Polytechnic Institute and State University on 2026-11-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.