NCT06906211 Low Intensity Focused Ultrasound for Chronic Pain: High Resolution Targeting of The Human Insula
| NCT ID | NCT06906211 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington D.C. Veterans Affairs Medical Center |
| Condition | Chronic Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2028-01-26 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2025-01-15 with a primary completion date of 2028-01-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this study, the research team will use low-intensity focused ultrasound (LIFU) to temporarily change brain activity in a brain region that is known to be involved in chronic pain. Through this, the research team hopes to learn about how the brain area works in response to pain. There are main questions this study aims to answer: * The effect of LIFU to inhibit the posterior region of the insula (PI) compared to sham stimulation in individuals with chronic back pain (CBP) and widespread pain symptoms. * The effect of LIFU to PI compared to sham stimulation to reduce pain intensity and magnitude of the Neurologic Pain Signature (NPS) in response to evoked thermal pain. * The effect of LIFU to PI compared to sham stimulation to reduce pain intensity and magnitude of Tonic Pain Signature in response to tonic pain.
Eligibility 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.
Contact & Investigator
Mary R Lee, MD
PRINCIPAL INVESTIGATOR
Washington D.C. Veterans Affairs Medical Center
Frequently Asked Questions
Who can join the NCT06906211 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 75 Years, studying Chronic Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06906211 currently recruiting?
Yes, NCT06906211 is actively recruiting participants. Contact the research team at mary.lee3@va.gov for enrollment information.
Where is the NCT06906211 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT06906211 clinical trial?
NCT06906211 is sponsored by Washington D.C. Veterans Affairs Medical Center. The principal investigator is Mary R Lee, MD at Washington D.C. Veterans Affairs Medical Center. The trial plans to enroll 66 participants.