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NOT YET RECRUITING
NCT07910396
NA

Focused Ultrasound Neuromodulation for Chronic Pain

Sponsor: University of Minnesota

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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