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Focused Ultrasound Neuromodulation for Chronic Pain
Sponsor: University of Minnesota
Summary
This study will evaluate the feasibility, tolerability, and preliminary analgesic effects of individualized Precision Confidence Mapping-guided low-intensity focused ultrasound neuromodulation in adults with chronic pain. Participants will undergo MRI and resting-state fMRI to identify an individualized SCAN-connected centromedian thalamic target. Participants will then complete two treatment arms in randomized order: focused centromedian thalamic low-intensity focused ultrasound and unfocused control low-intensity focused ultrasound. Each treatment arm includes five consecutive daily stimulation sessions, separated by a washout interval. The primary outcome is change in daily pain intensity measured using Brief Pain Inventory pain intensity items. Secondary outcomes include pain-related symptoms, physical function, fatigue, sleep disturbance, depressive symptoms, anxiety symptoms, pain catastrophizing, pain vigilance, neuropathic pain features, feasibility, tolerability, adverse events, blinding integrity, and exploratory neuroimaging measures.
Official title: Stimulating Somato-Cognitive Action Network With Low-Intensity Focused Ultrasound in Chronic Pain
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2027-01-04
Completion Date
2032-12-29
Last Updated
2026-11-02
Healthy Volunteers
No
Interventions
Focused PCM-Guided CMN LIFU
Focused low-intensity focused ultrasound will be delivered using the Attune Neurosciences ATTN201 device to an individualized SCAN-connected centromedian thalamic target identified from resting-state fMRI using Precision Confidence Mapping. Stimulation will be delivered once daily for five consecutive treatment days.
Unfocused Control LIFU
Unfocused control low-intensity focused ultrasound will use the same device placement, acoustic gel application, pulse timing, session duration, and five-day treatment schedule as focused stimulation. Randomized element delays will be used to produce diffuse acoustic output and negligible focal pressure at the intended deep brain target.
Locations (1)
Masonic Institute for the Developing Brain
Minneapolis, Minnesota, United States