Optimizing Accelerated TMS for Chronic Pain With Thompson Sampling

NCT07103135 | Recruiting Phase 1 FDA Device

• 1 other identifier: PSYCH-2025-33814
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.To establish the relationship between SCAN and AMN connectivity and cognitive- affective pain symptoms.
2. 2.To evaluate the efficacy of Thompson Sampling-optimized aiTBS across SCAN and AMN on affective and sensorimotor pain dimensions.
3. 3.To identify fMRI connectivity biomarkers predictive of treatment response and remission.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity

  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)

  3 months

Secondary Outcomes (18)

• Change in pain intensity

  Week 27

• Change in sleep quality score

  Week 21

• Change in sleep time

  Week 21

• Adherence to the protocol and the tolerability of the study visits/procedures

  Week 27

• Pain Catastrophizing Scale Score

  Day 0

Study Arms (1)

Study group

EXPERIMENTAL

Individuals with chronic pain

Device: MagVenture X100 Pro transcranial magnetic stimulation system

Interventions

MagVenture X100 Pro transcranial magnetic stimulation system DEVICE

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.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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)
• 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

You may not qualify 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:
• 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

Sponsors & Collaborators

• University of Minnesota: lead
• The Foundation for the Advancement of Clinical TMS: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander B Herman, MD, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• David Darrow

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Maple

CONTACT

612-946-1424; maple036@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a sham-controlled, single-blind, randomized study

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: August 5, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): August 31, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)