Status:
RECRUITING
Low Intensity Focused Ultrasound for Chronic Pain: High Resolution Targeting of The Human Insula
Lead Sponsor:
Washington D.C. Veterans Affairs Medical Center
Conditions:
Chronic Back Pain
Chronic Pain (Back / Neck)
Eligibility:
All Genders
21-75 years
Phase:
NA
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...
Detailed Description
Chronic pain is a major public health problem. An estimated 100 million Americans have experienced chronic pain producing significant economic and social burden. The estimated annual cost of chronic p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 26 2028
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06906211
Start Date
January 15 2025
End Date
January 26 2028
Last Update
April 2 2025
Active Locations (1)
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1
Washington DC Veterans Affairs Medical Center
Washington D.C., District of Columbia, United States, 20422