NCT07103135 Optimizing Accelerated TMS for Chronic Pain With Thompson Sampling
| NCT ID | NCT07103135 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Minnesota |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2030-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-03-01 with a primary completion date of 2030-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of accelerated intermittent theta burst stimulation (aiTBS) targeting personalized nodes within the somato-cognitive action network (SCAN) and action motor network (AMN) for the treatment of chronic pain. The study will employ Thompson Sampling, a Bayesian reinforcement learning algorithm, to optimize stimulation site selection based on individual response patterns. This approach has the potential to revolutionize pain management by improving treatment accessibility through shortened timelines, addressing individual variations in pain networks through precision targeting, and potentially achieving more robust pain relief through accelerated neuroplasticity. The specific aims of the study are: 1. To establish the relationship between SCAN and AMN connectivity and cognitive- affective pain symptoms. 2. To evaluate the efficacy of Thompson Sampling-optimized aiTBS across SCAN and AMN on affective and sensorimotor pain dimensions. 3. To identify fMRI connectivity biomarkers predictive of treatment response and remission.
Eligibility Criteria
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
Contact & Investigator
Alexander B Herman, MD, PhD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT07103135 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07103135 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07103135 currently recruiting?
Yes, NCT07103135 is actively recruiting participants. Contact the research team at maple036@umn.edu for enrollment information.
Where is the NCT07103135 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT07103135 clinical trial?
NCT07103135 is sponsored by University of Minnesota. The principal investigator is Alexander B Herman, MD, PhD at University of Minnesota. The trial plans to enroll 30 participants.
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