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Focused Ultrasound for the Complex Patient
Towards Treatment of the Complex Patient: Investigations of Low-intensity Focused Ultrasound
Who can join
Ages 18 to 75 · All sexes · Healthy volunteers welcome
Full 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 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. 4. Participants must rate pain intensity at 4/10 or greater on the Brief Pain Inventory-Short Form (BPI-SF) 5. 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. 6. Be in treatment for OUD including buprenorphine or methadone. 7. 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: 1. Evidence of neuropathic pain 2. Current DSM-5 substance use disorder other than OUD, tobacco use disorder 3. Current DSM-5 diagnosis of schizophrenia or schizo-affective disorder 4. Pregnant or breastfeeding 5. Daily use of benzodiazepines or opiates (other than buprenorphine or methadone) 6. 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. 7. Ferromagnetic implants or other contraindications for MRI 8. Unstable medical conditions such as congestive heart failure, unstable angina, poorly controlled arrhythmia active systemic infection end stage renal disease.
About the study
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.
What is being tested
- low intensity focused ultrasound (LIFU) (device)
Sponsor: Washington D.C. Veterans Affairs Medical Center · Participants: 25 · Started: Apr 29, 2024
Contact the study team
- Mary R Lee, MD · Phone: 202-745-8000
Official record on ClinicalTrials.gov — NCT06453109
Locations in the U.S.
| District of Columbia | Washington DC Veterans Affairs Medical Center, Washington D.C. |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.