Actively Recruiting
Low Intensity Focused Ultrasound for Chronic Pain: High Resolution Targeting of The Human Insula
Led by Washington D.C. Veterans Affairs Medical Center · Updated on 2025-04-02
66
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Low Intensity Focused Ultrasound for Chronic Pain: High Resolution Targeting of The Human Insula
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veterans aged 21 to 75 with Chronic Back Pain (CBP)
- CBP lasting daily for the last 3 months or at least half of the days for the last 6 months
- Pain rating of 4 or higher on the Brief Pain Inventory Short Form
- Presence of widespread pain symptoms including CBP and pain in a contralateral limb in fewer than 11 sites
You will not qualify if you...
- Surgery recommended as primary treatment for chronic back pain
- Current diagnosis of fibromyalgia
- Current substance use disorder except nicotine
- Unstable psychiatric disorder or not on stable medication for 4 or more weeks prior to screening
- Daily use of opiates
- Currently pregnant or breastfeeding
- Unable to understand the consent form
- History of head injury with loss of consciousness over 5 minutes, seizures, stroke, brain surgery, brain tumor, or multiple sclerosis
- History of metastatic cancer, rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus, or polymyositis
- Unintended weight loss of 20 pounds or more in the past year
- Cauda equina syndrome
- Ferromagnetic implants or other MRI contraindications
- Uncompensated congestive heart failure, unstable angina, poorly controlled arrhythmia, active systemic infection, or end stage renal disease
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington DC Veterans Affairs Medical Center
Washington D.C., District of Columbia, United States, 20422
Actively Recruiting
Research Team
M
Mary R Lee, MD
CONTACT
E
Evan Evan Lindeman, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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