Low Intensity Focused Ultrasound for Chronic Pain: High Resolution Targeting of The Human Insula
Washington D.C. Veterans Affairs Medical Center
66 participants
Jan 15, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria13
- 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.
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Interventions
Low-intensity focused ultrasound (LIFU) provides an energy source with millimeter resolution that can be focused anywhere in the brain safely and effectively for non-invasive and transient neuromodulation. LIFU is an important advance and of great significance for brain-mapping efforts, diagnostics, and therapies in neuroscience and particularly promising for addiction therapy as it provides unprecedented non-surgical access to the brain regardless of depth. Much lower intensities of focused ultrasound (LIFU) are used so that tissue damage does not occur, but neural activity can be modulated. LIFU utilizes acoustic energy at much lower levels to affect tissue by mechanical effects.
Locations(1)
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NCT06906211