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New treatment option for Chronic Pain
Official title Optimizing Accelerated TMS for Chronic Pain With Thompson Sampling
ClinicalTrials.gov ID: NCT07103135
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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:
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.