Recruiting

Low-Intensity Focused Ultrasound

Sponsor:

Virginia Polytechnic Institute and State University

Code:

NCT06297200

Conditions

Opioid Use Disorder

Chronic Pain

Anxiety Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Low-Intensity Focused Ultrasound

Low-Intensity Focused Ultrasound - sham

Study Details

Brief summary:

Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population.

Conditions

Opioid Use Disorder

Chronic Pain

Anxiety Disorder

Study ID

NCT06297200

Start date

Dec 4, 2024

Status verified date

Oct, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Males and females aged 18-65 years
2. Current diagnosis of Chronic Back Pain as defined by pain duration of at least three months, with back pain being an ongoing problem for at least half the days of the last six months.
3. Have evidence of central sensitization (CS) as measured by the Widespread Pain/Symptom Severity Index (WPSSI) with a score of Widespread Pain Index (WPI) ≥ 7 and Symptom Severity (SS) ≥ 5 or WPI = 3-6 and SS ≥ 9.
4. Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current opiate use disorder as diagnosed by the Structured Clinical Interview for DSM-5.
5. Be in treatment for opioid use disorder (OUD) including buprenorphine or methadone.
6. Meet the DSM-5 criteria for a current anxiety disorder: generalized anxiety disorder, post-traumatic stress disorder or social anxiety disorder as diagnosed by the Structured Clinical Interview for DSM-5.

Exclusion Criteria:

1. Evidence of neuropathic pain
2. Previous spine surgery
3. Current substance use disorder other than OUD or tobacco use disorder
4. Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder
5. Chronic Pain Conditions other than chronic back pain
6. Daily opiate use other than buprenorphine/methadone for OUD/pain control
7. Pregnant or breastfeeding
8. History of head injury, seizures, neurologic disorders including cerebrovascular disease, stroke, brain surgery, brain tumor, multiple sclerosis, or neurodegenerative diseases
9. History of metastasizing cancers, inflammatory disorder (rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus or polymyositis), unintended weight loss of 20 pounds or more in the last year, or cauda equina syndrome
10. Ferromagnetic implants or other contraindications for magnetic resonance imaging (MRI)
11. Evidence of arteriovenous malformation, aneurysm, infarct, meningioma, parenchymal brain tumor or evidence of neurodegenerative processes and/or white matter lesions greater than that expected for age as determined by the study neuroradiologist
12. Unstable medical conditions such as congestive heart failure, unstable angina, poorly controlled arrhythmia active system infection end stage renal disease

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Pain, Craving, and Anxiety measures

Multi visit - LIFU/Sham. Participants will complete pain, craving, and anxiety measures pre and post intervention.

Interventions

Low-Intensity Focused Ultrasound

A noninvasive brain stimulation device using low-intensity focused ultrasound (LIFU) - ultrasound will be used to test whether noninvasive brain stimulation can effect pain, craving, and anxiety.

Low-Intensity Focused Ultrasound - sham

A sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain.

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events via a neurological examination [ Time Frame: Assessed per participant, over the course of participation - an average of 4 weeks ]
  • Incidence of Treatment-Emergent Adverse Events via a side effects questionnaire [ Time Frame: Assessed per participant, over the course of participation - an average of 4 weeks ]
  • Changes in Heart Rate (HR) [ Time Frame: Assessed per participant, over the course of participation - an average of 4 weeks ]
  • Changes in Respiration Rate (RR) [ Time Frame: Assessed per participant, over the course of participation - an average of 4 weeks ]
  • Changes in mood via visual analog mood scale (VAMS) such as the wong-baker face scale. [ Time Frame: Assessed per participant, over the course of participation - an average of 4 weeks ]
  • Changes in Blood Pressure (BP) [ Time Frame: Assessed per participant, over the course of participation - an average of 4 weeks ]

Central Contacts and Locations

Central contacts

Jessica Florig, MPH

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

Locations

Fralin Biomedical Research Institute at VTC

Recruiting

Roanoke, Virginia, United States, 24016

Contacts

Jessica Florig, MPH

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

Principal Investigator:

Wynn Legon, PhD

More Information

Sponsor

Virginia Polytechnic Institute and State University

Last update posted

Nov 3, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Polytechnic Institute and State University on 2025-11-03.