Focused Ultrasound Neuromodulation for Chronic Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Oscar Miranda Dominguez, PhD
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for adults with chronic pain, including those with hemangioblastoma, sickle cell disease, or chronic pelvic pain syndrome. Participants must be able to undergo MRI scans and complete daily treatment sessions.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Focused PCM-Guided CMN LIFU
- Unfocused Control LIFU
Trial Overview
The study compares two types of low-intensity focused ultrasound treatments targeting the brain: one precisely aimed at a specific area linked to pain (focused), and another less targeted (unfocused). Each participant receives both treatments in random order.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants randomized to this sequence will receive unfocused control low-intensity focused ultrasound once daily for five consecutive treatment days during Arm 1, followed by a washout interval, then focused PCM-guided centromedian thalamic low-intensity focused ultrasound once daily for five consecutive treatment days during Arm 2.
Participants randomized to this sequence will receive focused PCM-guided centromedian thalamic low-intensity focused ultrasound once daily for five consecutive treatment days during Arm 1, followed by a washout interval, then unfocused control low-intensity focused ultrasound once daily for five consecutive treatment days during Arm 2.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
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