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NCT Number: NCT07686354

LIFU for Chronic Pain and Generalized Anxiety Disorder

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

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Key information

Conditions

Chronic Pain Anxiety Disorders Generalized Anxiety Disorder Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location contact

Jessica Research Associate, MPH

CONTACT

[email protected]

5405262261

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Intensity Focused Ultrasound

Device

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

Primary outcomes

  1. Safety - monitoring of possible symptoms

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

    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.

  2. Changes in Chronic Pain - self report

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

    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).

  3. Changes in Anxiety - self report

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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Research Associate, MPH

CONTACT

[email protected]

540-526-2261

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Registry information

Official study title

Accelerated Low-Intensity Focused Ultrasound (LIFU) for Chronic Pain and Generalized Anxiety Disorder: A Proof-of-Concept Case Series

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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