Low Intensity Focused Ultrasound for Chronic Pain: High Resolution Targeting of The Human Insula
- NCT ID
- NCT06906211
- Registry status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Washington D.C. Veterans Affairs Medical Center
- Conditions
- Chronic Back Pain, Chronic Pain (Back / Neck)
Overview
ClinicalTrials.gov lists this study as Recruiting.
Enrollment: 66 participants (Estimated).
What is being studied
- Device: low intensity focused ultrasound (LIFU)
Who may be eligible
- Ages
- 21 Years to 75 Years
- Sex
- All
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following 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.
Study locations
1 study location is listed.
Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.
Countries: United States
- District of Columbia, United States: 1
Sample of listed locations
- Washington DC Veterans Affairs Medical Center — Washington D.C., District of Columbia, 20422, United States — Recruiting
Study details
- Start date
- January 15, 2025
- Primary completion date
- January 26, 2028
- Completion date
- January 26, 2028
- First posted
- April 2, 2025
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT06906211
- Registry last updated
- August 25, 2026
- QualifiedStudies registry data refreshed
- October 5, 2026
- QualifiedStudies record fetched
- October 5, 2026
View NCT06906211 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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