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NCT Number: NCT06297200

Low-Intensity Focused Ultrasound and the Complex Patient

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

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Key information

Conditions

Opioid Use Disorder Anxiety Disorder Anxiety Disorders Chemically-Induced Disorders Chronic Pain Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid-Related Disorders Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

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 status: Recruiting

Location contact

Jessica Florig, MPH

CONTACT

[email protected]

540-526-2261

Wynn Legon, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Low-intensity focused ultrasound - sham

Device

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

Primary outcomes

  1. 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

    Any abnormal finding from the neurological exam will be recorded as an adverse event (AE) and tabulated with the side effects and tolerability data.

  2. 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

    Side effects and reported severity will be tabulated and summarized on a 5 point likert scale.

  3. Changes in Heart Rate (HR)

    Time frame: Assessed per participant, over the course of participation - an average of 4 weeks

    changes in HR compared pre/post LIFU and at follow up

  4. Changes in Respiration Rate (RR)

    Time frame: Assessed per participant, over the course of participation - an average of 4 weeks

    changes in RR compared pre/post LIFU and at follow up

  5. 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 mood scale compared pre/post LIFU and at follow up

  6. Changes in Blood Pressure (BP)

    Time frame: Assessed per participant, over the course of participation - an average of 4 weeks

    changes in BP (systolic and diastolic) compared pre/post LIFU and at follow up

Study contacts

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

Jessica Florig, MPH

CONTACT

[email protected]

540-526-2261

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Collaborators

  • Salem VA Medical Center
  • Washington DC VA Medical Center

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2024
Registry last updated
Nov 3, 2025

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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