Low-Intensity Focused Ultrasound and the Complex Patient

Investigations of Low-Intensity Focused Ultrasound Towards Treatment for the Complex Patient

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Opioid Use Disorder; Anxiety Disorder
• Intervention / Treatment: Device: Low-Intensity Focused Ultrasound; Device: Low-Intensity Focused Ultrasound - sham

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Florig, MPH; Phone Number: 540-526-2261; Email: jnw@vtc.vt.edu

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Recruiting
      • Fralin Biomedical Research Institute at VTC
      • Principal Investigator: Wynn Legon, PhD
      • Contact: Jessica Florig, MPH; Phone Number: 540-526-2261; Email: jnw@vtc.vt.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pain, Craving, and Anxiety measures; Multi visit - LIFU/Sham. Participants will complete pain, craving, and anxiety measures pre and post intervention.

Device: 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.; Device: Low-Intensity Focused Ultrasound - sham; A sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events via a neurological examination	Any abnormal finding from the neurological exam will be recorded as an adverse event (AE) and tabulated with the side effects and tolerability data.	Assessed per participant, over the course of participation - an average of 4 weeks
Changes in Heart Rate (HR)	changes in HR compared pre/post LIFU and at follow up	Assessed per participant, over the course of participation - an average of 4 weeks
Changes in Respiration Rate (RR)	changes in RR compared pre/post LIFU and at follow up	Assessed per participant, over the course of participation - an average of 4 weeks
Changes in Blood Pressure (BP)	changes in BP (systolic and diastolic) compared pre/post LIFU and at follow up	Assessed per participant, over the course of participation - an average of 4 weeks
Incidence of Treatment-Emergent Adverse Events via a side effects questionnaire	Side effects and reported severity will be tabulated and summarized on a 5 point likert scale.	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.	changes in mood scale compared pre/post LIFU and at follow up	Assessed per participant, over the course of participation - an average of 4 weeks

Collaborators and Investigators

• Sponsor: Virginia Polytechnic Institute and State University
• Collaborators: Salem VA Medical Center; Washington DC VA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Estimated): November 3, 2025
• Last Update Submitted That Met QC Criteria: October 31, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Pain; Neurologic Manifestations; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Anxiety Disorders; Opioid-Related Disorders; Chronic Pain
• Other Study ID Numbers: 24-050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes