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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