Focused Ultrasound for Anxiety and Pain Conditions

Focused Ultrasound for the Complex Patient

Recruiting N/A Interventional Study
Opioid Use Disorder Chronic Back Pain Anxiety
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
25 (estimated)
Sponsor
Washington D.C. Veterans Affairs Medical Center · Federal
Who this trial is looking for

This trial is looking for adults aged 18-75 with chronic back pain, anxiety, and opioid use disorder. Participants will receive low intensity focused ultrasound treatment, and their pain and anxiety will be assessed during the trial.

Are You a Good Fit for This Trial?
Must be taking BuprenorphineMethadone
Rules you out Neuropathic painSchizophreniaPregnancyUnstable heart conditions

You may be able to join if

  • I am between 18 and 75 years old.
  • I have chronic back pain that has lasted for at least three months.
  • I have been diagnosed with opioid use disorder.
  • I am currently receiving treatment for opioid use disorder.
  • I meet the criteria for an anxiety disorder.
  • I rate my pain intensity at 4 out of 10 or greater.
  • I have evidence of central sensitization based on specific scoring.

You may not be able to join if

  • I have evidence of neuropathic pain.
  • I have another substance use disorder other than opioid use disorder.
  • I have a diagnosis of schizophrenia or schizo-affective disorder.
  • I am pregnant or breastfeeding.
  • I use benzodiazepines or opiates daily outside of my treatment.
  • I have a history of seizures or significant neurological disorders.
  • I have unstable medical conditions like heart failure or active infections.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
The goal of this clinical trial is to to inhibit the anterior insula (AI) with low intensity focused ultrasound (LIFU) to determine the causal role for the AI in pain processing, anxiety, and opiate cue-induced craving. The main question\[s\] it aims to answer are: * the safety and tolerability of LIFU delivered bilaterally to AI compared to sham stimulation in individuals with opiate use disorde…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Males and females aged 18-75 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 meas…
Contacts

Mary R Lee, MD

202-745-8000

mary.lee3@va.gov

CONTACT

Krystian Burum, MS

krystian.burum@va.gov

CONTACT