Using focused ultrasound to treat chronic pain
Low Intensity Focused Ultrasound for Chronic Pain: High Resolution Targeting of The Human Insula
This study is testing if low-intensity focused ultrasound can help people with chronic back pain feel less pain by targeting a specific part of the brain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | Washington D.C. Veterans Affairs Medical Center Federal |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06906211 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of low-intensity focused ultrasound (LIFU) to modulate brain activity in the insula, a region associated with chronic pain. The research aims to compare the effects of LIFU on pain intensity and neurological pain signatures in individuals suffering from chronic back pain. By targeting the posterior insula, the study seeks to provide insights into the brain's response to pain and evaluate the potential of LIFU as a non-addictive treatment option. Participants will undergo LIFU or sham stimulation to assess the efficacy of this approach in reducing pain symptoms.
Who should consider this trial
Good fit: Ideal candidates include veterans aged 21 to 75 with chronic back pain lasting at least three months and experiencing widespread pain symptoms.
Not a fit: Patients who are recommended for surgery as a primary treatment for chronic back pain or have a current diagnosis of fibromyalgia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a non-addictive alternative for managing chronic pain.
How similar studies have performed: While the use of LIFU is a novel approach, similar neuromodulation techniques have shown promise in treating chronic pain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Veterans aged 21 to 75 with Chronic Back Pain (CBP). * CBP duration daily for last 3 months or half of days for last 6 months * Endorse pain rating of 4/10 BPI-SF * Evidence of widespread pain symptoms as determined by report of CBP and pain in a contralateral limb (pain in the upper, lower, left or right side of the body) in fewer than 11 sites. Upper body sites include hand, wrist, elbow or shoulder. Lower sites include hip, knee, ankle or foot. Exclusion Criteria: * Surgery recommended as primary treatment intervention for CBP * Current diagnosis of fibromyalgia * Current substance use disorder other than nicotine. * Psychiatric disorder and not on a stable pharmacologic regimen for ≥ 4 weeks prior to screening * Opiate use daily * Currently pregnant or breast feeding. * Unable to understand the consent form. * History of head injury with loss of consciousness for more than 5 minutes, seizures, history of stroke, brain surgery, brain tumor, multiple sclerosis. * History of metastatic cancer, rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus, or polymyositis * Unintended weight loss of 20 pounds or more in the last year * Cauda equina syndrome * Ferromagnetic implants or other contraindications for MRI * Uncompensated congestive heart failure, unstable angina, poorly controlled arrhythmia, active systemic infection end stage renal disease.
Where this trial is running
Washington D.C., District of Columbia
- Washington DC Veterans Affairs Medical Center — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Mary R Lee, MD — Washington D.C. Veterans Affairs Medical Center
- Study coordinator: Mary R Lee, MD
- Email: mary.lee3@va.gov
- Phone: 202-745-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.