Low-Intensity Focused Ultrasound and the Complex Patient

NCT06297200 | Recruiting FDA Device

• 1 other identifier: 24-050
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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 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 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

• 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

Study Arms (1)

Pain, Craving, and Anxiety measures

EXPERIMENTAL

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

Device: Low-Intensity Focused Ultrasound; Device: Low-Intensity Focused Ultrasound - sham

Interventions

Low-Intensity Focused Ultrasound DEVICE

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.

Pain, Craving, and Anxiety measures

Low-Intensity Focused Ultrasound - sham DEVICE

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

Pain, Craving, and Anxiety measures

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged 18-65 years
• 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.
• 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.
• 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.
• Be in treatment for opioid use disorder (OUD) including buprenorphine or methadone.
• 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.

You may not qualify if:

• Evidence of neuropathic pain
• Previous spine surgery
• Current substance use disorder other than OUD or tobacco use disorder
• Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder
• Chronic Pain Conditions other than chronic back pain
• Daily opiate use other than buprenorphine/methadone for OUD/pain control
• Pregnant or breastfeeding
• History of head injury, seizures, neurologic disorders including cerebrovascular disease, stroke, brain surgery, brain tumor, multiple sclerosis, or neurodegenerative diseases
• 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
• Ferromagnetic implants or other contraindications for magnetic resonance imaging (MRI)
• 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
• Unstable medical conditions such as congestive heart failure, unstable angina, poorly controlled arrhythmia active system infection end stage renal disease

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• Salem VA Medical Center: collaborator
• Washington DC VA Medical Center: collaborator

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jessica Florig, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Sham trials will be utilized within subject. All subjects will receive sham and ultrasound conditions.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 7, 2024
• Study Start: December 4, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)