Focused Ultrasound for the Complex Patient

Launched by WASHINGTON D.C. VETERANS AFFAIRS MEDICAL CENTER · Jun 5, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Focused Ultrasound for the Complex Patient," is exploring a new treatment approach using low-intensity focused ultrasound (LIFU) to help manage pain, anxiety, and cravings related to opioid use disorder. The researchers want to see if targeting a specific brain area, called the anterior insula, can make a difference in how people experience pain and anxiety, as well as how strongly they feel the urge to use opioids. Participants will be divided into two groups: one will receive the actual treatment, while the other will receive a placebo (sham stimulation) that doesn’t have any therapeutic effect.

To be eligible for this study, participants need to be between 18 and 75 years old and have chronic back pain lasting at least three months, along with a current diagnosis of opioid use disorder and an anxiety disorder. They should also be undergoing treatment for their opioid use disorder with medications like buprenorphine or methadone. Participants will undergo several assessments, including MRI scans and surveys, to ensure the treatment is safe and to see how well it works. This trial is currently recruiting participants, and it’s a great opportunity for individuals experiencing these challenging conditions to explore a potentially innovative treatment option.

Gender

ALL

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.