Personalized accelerated TMS guided by Thompson Sampling for chronic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional effort delivers accelerated intermittent theta burst stimulation (aiTBS) using the MagVenture X100 Pro to personalized brain targets within the somato-cognitive action network (SCAN) and the action motor network (AMN). A Bayesian reinforcement-learning method called Thompson Sampling will adaptively select stimulation sites based on each participant’s response patterns across sessions. Eligible adults have chronic pain for at least 12 months that is refractory to two medication classes and will undergo multiple short TMS sessions over a condensed timeline. Outcomes will include safety, changes in affective and sensorimotor pain measures, and network connectivity to identify responders and refine targeting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Ages 18 years or older
* Ability to provide written informed consent
* Ability to read and to communicate verbally and in writing in English
* Chronic pain persisting for at least 12 months
* Pain refractory to oral pain medication (defined as failing at least two different medication classes)
* Average pain intensity of ≥5 on the Numerical Rating Scale (NRS) over the past two weeks
* Stable pain medication regimen for at least 4 weeks prior to enrollment
* Willing and able to attend all study visits and comply with study procedures

Exclusion Criteria:

* Current substance use disorder (except for nicotine or cannabis) as determined by DSM-5 criteria
* Active suicidal ideation with intent or plan as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS)
* Lifetime history of bipolar disorder, schizophrenia, or other psychotic disorder as determined by medical history
* Self-reported unstable medical conditions that would pose increased risks for TMS or MRI
* Pregnancy (as determined by urine pregnancy test) or planned pregnancy during the study period
* Contraindications to TMS, including:
* History of seizure or epilepsy
* Metallic implants in the head (excluding dental fillings)
* Cardiac pacemaker or other implanted medical devices
* History of significant head trauma
* History of intracranial surgery
* Medication that significantly lowers seizure threshold that cannot be safely held
* Contraindications to MRI, including:
* Claustrophobia
* Metallic implants or devices
* Inability to lie flat for the duration of the scan
* Current use of high-dose opioids (\>90 morphine milligram equivalents daily)
* Participation in another clinical trial of an investigational medication or device within 30 days prior to enrollment
* Any condition that, in the investigator\'s opinion, would make it unsafe or difficult for the participant to complete the study

Where it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Alexander B Herman, MD, PhD — University of Minnesota
• Study coordinator: Matthew Maple
• Email: maple036@umn.edu
• Phone: 612-946-1424

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.