University of Minnesota
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.
This is a single-site, double-blind, randomized, two-condition crossover feasibility trial evaluating Precision Confidence Mapping-guided low-intensity focused ultrasound neuromodulation in adults with chronic pain. The study will enroll adults with chronic pain of any etiology, defined as pain present for at least 3 months. The study is designed to include participants across multiple chronic pain populations, including sickle cell disease and chronic pelvic, bladder, or other chronic pain conditions. Participants will complete an initial screening and a baseline visit that includes informe…
Inclusion Criteria: * Age 18 years or older at the time of enrollment * Able to provide written informed consent * Able to read and communicate verbally and in writing in English * Able and willing to comply with all study procedures, including MRI, LIFU sessions, remote REDCap questionnaires, and daily pain diary completion * Chronic pain of any etiology, defined as pain present for at least 3 months * Average pain intensity of at least 3 out of 10 on the Numeric Rating Scale over the prior 4 weeks or based on participant report during screening * Stable pain medication regimen for at least…
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 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.
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