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| Name | Class |
|---|---|
| The Foundation for the Advancement of Clinical TMS | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Individuals with chronic pain |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity | NRS Scores | Week 27 |
| Change in sleep quality score | Measured by Garmin | Week 21 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Maple | Contact | 612-946-1424 | maple036@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alexander B Herman, MD, PhD | University of Minnesota | Principal Investigator |
| David Darrow | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This is a sham-controlled, single-blind, randomized study
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| Change in sleep time | Measured by Garmin | 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. | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | Week 21 |