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Recruiting NCT07103135

Optimizing Accelerated TMS for Chronic Pain With Thompson Sampling

Phase I Interventional Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MagVenture X100 Pro transcranial magnetic stimulation system.
Who it may be relevant to
Registry conditions: Chronic Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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]
Secondary outcome measures (12)
  • Change in pain intensity [Time frame: Week 27]
  • Change in sleep quality score [Time frame: Week 21]
  • Change in sleep time [Time frame: Week 21]
  • Adherence to the protocol and the tolerability of the study visits/procedures [Time frame: Week 27]
  • Pain Catastrophizing Scale Score [Time frame: Day 0]
  • Pain Catastrophizing Scale Score [Time frame: Week 15]
  • Pain Catastrophizing Scale Score [Time frame: Week 21]
  • PROMIS Emotional Distress Score [Time frame: Day 0]
  • PROMIS Emotional Distress Score [Time frame: Week 15]
  • PROMIS Emotional Distress Score [Time frame: Week 21]
  • Pain vigilance and awareness questionnaire (PVAQ) [Time frame: Day 0]
  • Pain vigilance and awareness questionnaire (PVAQ) [Time frame: Week 15]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT07103135 · PSYCH-2025-33814

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗