Optimizing Accelerated TMS for Chronic Pain With Thompson Sampling
Launched by UNIVERSITY OF MINNESOTA · Jul 31, 2025
Trial Information
Current as of August 19, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring a new way to treat chronic pain using a special kind of brain stimulation called accelerated intermittent theta burst stimulation (aiTBS). The treatment targets specific areas in the brain involved in how pain is felt and processed, and uses a smart computer program called Thompson Sampling to personalize where the stimulation is applied based on each person’s response. The goal is to find a faster, more effective treatment that can better relieve pain by tailoring it to each individual’s brain activity.
People who are 18 or older with chronic pain lasting at least a year, who haven’t found relief from at least two types of pain medications, and who have a moderate to severe level of pain may be eligible to join. Participants will need to be able to communicate in English and agree to attend all study visits. The study will carefully check safety and may involve brain scans (MRI) and repeated brain stimulation sessions. Some people, such as those with certain medical conditions, pregnancy, or implanted medical devices, may not be able to participate. This study is not yet recruiting but aims to offer a promising new option for those struggling with long-term pain that hasn’t improved with standard treatments.
Gender
ALL
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
About University Of Minnesota
The University of Minnesota is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on interdisciplinary collaboration, the university leverages its extensive resources and expertise to conduct cutting-edge studies aimed at improving patient outcomes and addressing critical health challenges. Its robust clinical trial program emphasizes ethical standards, patient safety, and scientific rigor, contributing to the development of novel therapies and interventions that enhance medical practice and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Alexander B Herman, MD, PhD
Principal Investigator
University of Minnesota
David Darrow
Principal Investigator
University of Minnesota
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported