Focused Ultrasound for the Complex Patient
Washington D.C. Veterans Affairs Medical Center · with National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA) · NCT06453109
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 25
- US sites recruiting
- 1
- Study start
- April 29, 2024
- Record last updated
- November 20, 2024
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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 disorder (OUD), anxiety, and chronic back pain
- the effects of LIFU vs sham on measures of pain processing, anxiety symptoms, and opiate cue-induced craving
Participants will undergo anatomical MRI, neurological assessment, clinical assessment and patient query to assess the safety and tolerability of LIFU vs sham.
Being studied: low intensity focused ultrasound (LIFU)
Conditions: Opioid Use Disorder; Chronic Back Pain; Anxiety
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Males and females aged 18-75 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.
- Participants must rate pain intensity at 4/10 or greater on the Brief Pain Inventory-Short Form (BPI-SF)
- Meet the DSM-5 criteria for current opiate use disorder as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
- Be in treatment for 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 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5).
Exclusion Criteria
- Evidence of neuropathic pain
- Current DSM-5 substance use disorder other than OUD, tobacco use disorder
- Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder
- Pregnant or breastfeeding
- Daily use of benzodiazepines or opiates (other than buprenorphine or methadone)
- History of seizures, neurologic disorders, including cerebrovascular disease, history of stroke, brain surgery, brain tumor, multiple sclerosis, or neurodegenerative diseases. They will not have 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 MRI
- Unstable medical conditions such as congestive heart failure, unstable angina, poorly controlled arrhythmia active systemic infection end stage renal disease.
Recruiting US locations
Washington DC Veterans Affairs Medical Center
Washington D.C., DC 20422
Site contact: Mary R Lee, MD · (202) 745-8000 · mary.lee3@va.gov
Study contacts (from the official record)
- Mary R Lee, MD · 202-745-8000 · mary.lee3@va.gov
- Krystian Burum, MS · krystian.burum@va.gov
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