Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06297200

Low-Intensity Focused Ultrasound and the Complex Patient

Led by Virginia Polytechnic Institute and State University · Updated on 2025-11-03

25

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

Sponsors

V

Virginia Polytechnic Institute and State University

Lead Sponsor

S

Salem VA Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Low-Intensity Focused Ultrasound and the Complex Patient

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females aged 18-65 years
  • Current diagnosis of Chronic Back Pain lasting at least three months, with pain on at least half the days in the last six months
  • Evidence of central sensitization measured by the Widespread Pain/Symptom Severity Index with specific score thresholds
  • Meet DSM-5 criteria for current opioid use disorder diagnosed by Structured Clinical Interview
  • Currently in treatment for opioid use disorder with buprenorphine or methadone
  • Meet DSM-5 criteria for a current anxiety disorder (generalized anxiety disorder, PTSD, or social anxiety disorder) diagnosed by Structured Clinical Interview
Not Eligible

You will not qualify if you...

  • Evidence of neuropathic pain
  • Previous spine surgery
  • Current substance use disorder other than opioid use disorder or tobacco use disorder
  • Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder
  • Chronic pain conditions other than chronic back pain
  • Daily opioid use other than buprenorphine or methadone for opioid use disorder or 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 disorders (rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus, polymyositis), unintended weight loss of 20 pounds or more in the last year, or cauda equina syndrome
  • Ferromagnetic implants or other contraindications for MRI
  • Evidence of brain abnormalities or neurodegenerative processes as determined by neuroradiologist
  • Unstable medical conditions such as congestive heart failure, unstable angina, poorly controlled arrhythmia, active systemic infection, or end stage renal disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, United States, 24016

Actively Recruiting

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Research Team

J

Jessica Florig, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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