Chronic PainPhase 1NCT07103135
Optimizing Accelerated TMS for Chronic Pain With Thompson Sampling
A Phase 1 study testing MagVenture X100 Pro transcranial magnetic stimulation system in people with Chronic Pain, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- MagVenture X100 Pro transcranial magnetic stimulation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 31 Aug 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Matthew Maple, 612-946-1424, maple036@umn.edu
About this study
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:
- To establish the relationship between SCAN and AMN connectivity and cognitive- affective pain symptoms.
- To evaluate the efficacy of Thompson Sampling-optimized aiTBS across SCAN and AMN on affective and sensorimotor pain dimensions.
- To identify fMRI connectivity biomarkers predictive of treatment response and remission.
- Conditions
- Chronic Pain
- Being tested
- MagVenture X100 Pro transcranial magnetic stimulation system
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagVenture X100 Pro transcranial magnetic stimulation systemDevice
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 | Role | What they receive |
|---|---|---|
| Study group | Experimental | Individuals with chronic pain Receives: Device: MagVenture X100 Pro transcranial magnetic stimulation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Secondary outcomes (18)
Change in pain intensity
NRS Scores
Measured: Week 27
Change in sleep quality score
Measured by Garmin
Measured: Week 21
Change in sleep time
Measured by Garmin
Measured: Week 21
Adherence to the protocol and the tolerability of the study visits/procedures
Adherence to the protocol will be measured as participants completing at least 80% of the study activities. Tolerability: Measured by the average patient rating across study procedures. After completion of the study, we will collect feedback using a 5-point likert scale for measuring tolerability, we expect the average scores to be above 3.
Measured: Week 27
Pain Catastrophizing Scale Score
The PCS is a 13-item questionnaire with each item scored 0-4, with higher scores indicating a worse outcome (higher tendency to catastrophize)
Measured: Day 0
Pain Catastrophizing Scale Score
The PCS is a 13-item questionnaire with each item scored 0-4, with higher scores indicating a worse outcome (higher tendency to catastrophize)
Measured: Week 15
Pain Catastrophizing Scale Score
The PCS is a 13-item questionnaire with each item scored 0-4, with higher scores indicating a worse outcome (higher tendency to catastrophize)
Measured: Week 21
PROMIS Emotional Distress Score
15 items asking about anxiety and depression scored 1-5 with higher scores indicating worse outcomes (more severe symptoms of anxiety and depression)
Measured: Day 0
PROMIS Emotional Distress Score
15 items asking about anxiety and depression scored 1-5 with higher scores indicating worse outcomes (more severe symptoms of anxiety and depression)
Measured: Week 15
PROMIS Emotional Distress Score
15 items asking about anxiety and depression scored 1-5 with higher scores indicating worse outcomes (more severe symptoms of anxiety and depression)
Measured: Week 21
Pain vigilance and awareness questionnaire (PVAQ)
The PVAQ is a 16-item questionnaire, where each item is scored as a six-point Likert scale that ranges from zero (never) to five (always), resulting in a sum score between zero and 80. Higher scores indicate worse outcomes (greater attention to pain)
Measured: Day 0
Pain vigilance and awareness questionnaire (PVAQ)
The PVAQ is a 16-item questionnaire, where each item is scored as a six-point Likert scale that ranges from zero (never) to five (always), resulting in a sum score between zero and 80. Higher scores indicate worse outcomes (greater attention to pain)
Measured: Week 15
Pain vigilance and awareness questionnaire (PVAQ)
The PVAQ is a 16-item questionnaire, where each item is scored as a six-point Likert scale that ranges from zero (never) to five (always), resulting in a sum score between zero and 80. Higher scores indicate worse outcomes (greater attention to pain)
Measured: Week 21
Pain interference score on the Brief Pain Inventory (BPI)
The BPI is 11 items asking about pain sensations and interference with normal activity, all scored 0-10 with higher scores indicating worse outcomes (more pain or more interference due to pain)
Measured: Day 0
Pain interference score on the Brief Pain Inventory (BPI)
The BPI is 11 items asking about pain sensations and interference with normal activity, all scored 0-10 with higher scores indicating worse outcomes (more pain or more interference due to pain)
Measured: Week 15
Pain interference score on the Brief Pain Inventory (BPI)
The BPI is 11 items asking about pain sensations and interference with normal activity, all scored 0-10 with higher scores indicating worse outcomes (more pain or more interference due to pain)
Measured: Week 21
Connectivity between SCAN and AMN connectivity on fMRI
The metric of connectivity will be the seeded correlation between the SCAN and the AMN
Measured: Day 0
Changes in SCAN and AMN connectivity on fMRI
The metric of connectivity will be the seeded correlation between the SCAN and the AMN
Measured: Week 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Mar 2026
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a sham-controlled, single-blind, randomized study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- The Foundation for the Advancement of Clinical TMS
- Responsible party
- Sponsor
- Investigators
- Alexander B Herman, MD, PhD, Principal investigator, University of MinnesotaDavid Darrow, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103135
- Sponsor's protocol ID
- PSYCH-2025-33814
- Status last verified
- Mar 2026
- First submitted
- 24 Apr 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Accelerated TMS for Chronic Pain With Thompson Sampling
- ClinicalTrials.gov ID
- NCT07103135
- Acronym / sponsor ID
- PSYCH-2025-33814
- Conditions
- Chronic Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- The Foundation for the Advancement of Clinical TMS
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To establish the relationship between SCAN and AMN connectivity and cognitive- affective pain symptoms.
- To evaluate the efficacy of Thompson Sampling-optimized aiTBS across SCAN and AMN on affective and sensorimotor pain dimensions.
- To identify fMRI connectivity biomarkers predictive of treatment response and remission.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a sham-controlled, single-blind, randomized study
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: MagVenture X100 Pro transcranial magnetic stimulation systemIndividuals with chronic pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagVenture X100 Pro transcranial magnetic stimulation systemThe 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. | Device | Study group |
Primary outcome
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)
18 secondary outcomes
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
Pain vigilance and awareness questionnaire (PVAQ)
Time frame: Week 21
Pain interference score on the Brief Pain Inventory (BPI)
Time frame: Day 0
Pain interference score on the Brief Pain Inventory (BPI)
Time frame: Week 15
Pain interference score on the Brief Pain Inventory (BPI)
Time frame: Week 21
Connectivity between SCAN and AMN connectivity on fMRI
Time frame: Day 0
Changes in SCAN and AMN connectivity on fMRI
Time frame: Week 21
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander B Herman, MD, PhD principal investigator
University of Minnesota
David Darrow principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MagVenture X100 Pro transcranial magnetic stimulation system in people with Chronic Pain, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Maple (612-946-1424, maple036@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.