NCT07103135 · University of Minnesota
Optimizing Accelerated TMS for Chronic Pain With Thompson Sampling
What this study is about
The purpose of this study is to evaluate the safety and effectiveness 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.
View original scientific description
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.
Interventions
DEVICE
MagVenture X100 Pro transcranial magnetic stimulation system
The study intervention involves the use of the MagVenture X100 Pro transcranial magnetic stimulation system to deliver accelerated intermittent theta burst stimulation (aiTBS) to personalized targets within the somato-cognitive action network (SCAN) and action motor network (AMN) for the treatment of chronic pain.
Primary outcome measures
Change in pain intensity
Time frame: 3 months
measured by the Numerical Rating Scale (NRS) from baseline to after completion of the trial (approximately 3 months). For the NRS, the scores range from 0 to 10, where 0 indicates no pain (better outcome) and 10 is the worst pain that the participant can imagine (worse outcome)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Minneapolis, Minnesota
Collaborators
The Foundation for the Advancement of Clinical TMS
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2026 · Source of record for eligibility and locations