Focused ultrasound aimed at a brain area for chronic pain

Trial details

Who runs it

University of Minnesota

Trial code

NCT07910396

Record updated

2 November 2026

Original description

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.Read full original descriptionShow less

Stimulating Somato-Cognitive Action Network With Low-Intensity Focused Ultrasound in Chronic Pain

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.

Inclusion: 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 2 weeks prior to the first LIFU session, when clinically feasible.

Exclusion: Sacral neuromodulation implant; Major starting, stopping, or dose escalation of pain medications or other medications likely to substantially affect pain ratings during the baseline monitoring period or immediately before planned LIFU stimulation; Severe functional neurological deficit from prior stroke, central nervous system lesion, or other neurological condition that, in the judgment of the PI, would interfere with study participation, interpretation of study outcomes, or participant safety; Diagnosed epilepsy or prior seizure; Standard MRI contraindications, including ferromagnetic implants, pacemaker or other non-MRI-compatible implanted devices, cochlear implant, intracranial aneurysm clip, retained metallic foreign body, or other MRI-incompatible device or condition; Scalp wound, dermatologic condition, or local sensitivity over the temporal window region that would interfere with safe device placement or acoustic coupling; Acute pain episode, vaso-occlusive crisis, injury, infection, or other acute medical event at the time of screening, MRI, or planned LIFU stimulation that requires emergency evaluation, hospitalization, or a major change in pain treatment; History of head trauma diagnosed as concussion, if in the judgment of the PI the event or residual symptoms could increase risk, interfere with study participation, or compromise interpretation of study outcomes; Current use of, or recent withdrawal from, medications that can increase seizure risk, if in the judgment of the PI this would increase risk from study participation; Active central nervous system infection, active inflammatory central nervous system disease, or other unstable neurological disorder; Unstable medical or psychiatric condition that, in the judgment of the PI, would increase risk, interfere with study participation, or compromise interpretation of study outcomes; Current substance use disorder, other than nicotine, alcohol, or cannabis use, that in the judgment of the PI would interfere with participation or safety; Any other clinically significant condition or circumstance that, in the judgment of the PI, would create an unacceptable risk to the participant, prevent completion of required study procedures, or substantially compromise interpretation of study outcomes; Inability of the participant's head to fit within the MRI head coil while wearing the MR-compatible device; Inability to tolerate MRI scanning, including severe claustrophobia not manageable with standard non-sedating accommodations; Implanted metallic hardware in the skull, scalp, or temporal bone that would interfere with LIFU targeting or acoustic transmission; Inability to tolerate the LIFU device setup, including headgear placement, acoustic coupling gel, or the 60-minute session duration; Pregnancy or current breastfeeding; Participation in another interventional clinical trial that could interfere with study outcomes or participant safety; Children; Pregnant women/persons; Fetuses; Neonates; Prisoners; Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent; Non-English speakers; Individuals unable to read; Students of the researcher; Individuals approached during a stressful situation, such as emergency care, childbirth, or another crisis setting.

ClinicalTrials.gov NCT07910396