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Chronic PainPainDevice

What this study is

Simplified from ClinicalTrials.gov

Testing low-intensity focused ultrasound aimed at a deep brain area found with individual brain scans, to see whether it can ease chronic pain and is tolerable, in adults 18 and older with chronic pain. Everyone gets both a focused and an unfocused (control) version, in random order, over five daily sessions each.

Read the original summary from ClinicalTrials.gov

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.

What's being tested

  • Focused PCM-Guided CMN LIFU

    Intervention · DEVICE

    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

    Intervention · DEVICE

    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.

Study details

Official title
Stimulating Somato-Cognitive Action Network With Low-Intensity Focused Ultrasound in Chronic Pain
Sponsor
University of Minnesota
Conditions
Chronic Pain · Sickle Cell Disease · Chronic Pelvic Pain Syndrome
Enrolling
80 people
Starts
2027-01-04
Est. completion
2032-12-29
Design
Triple-blind, randomized, crossover
Record
View on ClinicalTrials.gov ↗