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| ID | Type | Description | Link |
|---|---|---|---|
| Schmitt program | Other Grant/Funding Number | URMC |
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The first goal of this study is to see how brain activity changes in people with fibromyalgia after they get a treatment called rTMS (repetitive transcranial magnetic stimulation). Researchers are looking at how the parts of the brain that control movement (called motor cortices) respond to this treatment.
The second goal is to find out if the changes in brain activity are different between the right and left sides of the brain, depending on which side gets the treatment.
The first aim of this study is to measure changes in fibromyalgia-related functional brain plasticity, as indicated by the functional "connectopy" of the right and left primary motor cortices in response to rTMS treatment. The second aim of this study is to explore whether changes in motor cortex connectopy differ between the right and left motor cortex (M1) following rTMS administered to each respective hemisphere.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| right M1 rTMS | Active Comparator |
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| Left M1 rTMS | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS | Other | Using rTMS, which is a procedure that uses magnetic fields to stimulate nerve cells in the brain, to investigate its potential analgesic effects in fibromyalgia. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Primary Motor Cortex (M1) Connectopy Profile | Resting-state fMRI will be used to derive connectopy embeddings of the primary motor cortex (M1). Connectopy embeddings from the stimulated side will be extracted from significant baseline-defined clusters. A single value per participant is derived by averaging the embedding values within this cluster. Higher scores indicate increased similarity to healthy reference profiles (improved functional connectivity), while lower scores indicate deviation from healthy reference patterns (reduced functional connectivity). | Baseline and post-treatment (after 10 sessions of rTMS over 2 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Pain Intensity (Numeric Rating Scale, NRS) | Self-reported average pain over 7 days using the Numeric Rating Scale (0 = "no pain at all" to 10 = "worst pain possible"). A single number is derived as the mean of daily ratings over 7 days. Lower scores indicate reduced pain intensity, while higher scores indicate worse pain intensity. | Baseline and post-treatment (following 10 rTMS sessions, within 7 days of completing rTMS sessions ). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivia Caraccio, BS/BA | Contact | 5853136322 | Olivia_Caraccio@URMC.Rochester.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14620 | United States |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D059350 | Chronic Pain |
| D000098653 | Nociplastic Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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This study will utilize single-blind as blinded outcome assessment, ensuring that investigators responsible for outcome evaluation and data analysis remain blinded to patients and whether treatment was delivered to the right or left motor cortex (M1). However, the clinician administering rTMS will not be blinded to the intervention arm (right vs left).
| Mean Change in Pressure Pain Threshold (PPT) | Pressure pain threshold (PPT) will be measured using a pressure algometer (Wagner Inc.). Pressure will be applied at a constant rate until participants indicate pain perception. The threshold (kg/cm²) will be recorded. A single value is derived by averaging three threshold readings from the target site. Higher thresholds indicate reduced pain sensitivity (improvement), while lower thresholds indicate increased pain sensitivity (worsening). | Baseline and post-treatment (within 7 days of completing rTMS sessions ) |
| Mean Change in Fatigue (Patient-Reported Outcomes Measurement Information System-PROMIS Fatigue 13a Subscale) | Fatigue will be assessed using the PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue 13a subscale, which ranges from 13 to 65. Higher scores indicate greater fatigue severity (worsening), whereas lower scores indicate less fatigue (improvement). | Baseline and post-treatment (within 7 days of completing rTMS sessions). |
| Mean Change in Sleep Disturbance (Patient-Reported Outcomes Measurement Information System - PROMIS Sleep Disturbance 8a Subscale) | Sleep disturbance will be assessed using the PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance 8a subscale, which ranges from 8 to 40. Higher scores indicate greater sleep disturbance (worsening), whereas lower scores indicate improved sleep. | Baseline and post-treatment (within 7 days of completing rTMS sessions). |
| Mean Change in the Short-Form McGill Pain Questionnaire | The Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) has 22 items assessing continuous, intermittent, neuropathic, and affective pain. Items are rated 0-10, with total scores ranging 0-220, where higher scores indicate greater pain severity. | Baseline and post-treatment (within 7 days of completing rTMS sessions). |
| Mean Change in Central Sensitization Index | Central Sensitization Index (CSI) is a 25-item self-reported measure that determines whether the symptoms of patients are associated with central sensitization. Item responses are on a 4-point scale and can be answered as follows: 0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, and 4 = Always. The total score will be used to estimate the severity of the central sensitization symptoms. | Baseline and post-treatment (within 7 days of completing rTMS sessions). |
| Mean Change in Pain Catastrophizing Scale | The Pain Catastrophizing Scale (PCS) has 13 items measuring rumination, magnification, and helplessness related to pain. Items are rated 0-4, with total scores ranging 0-52; higher scores indicate greater catastrophizing. | Baseline and post-treatment (within 7 days of completing rTMS sessions). |
| Mean Change in the Pain Self-repot Survey for the Assessment of Fibromyalgia | The Patient Self-Report Survey for the Assessment of Fibromyalgia has 9 items measuring widespread pain and symptom severity. Scores range 0-31, with higher scores indicating greater fibromyalgia symptom burden. | Baseline and post-treatment (within 7 days of completing rTMS sessions). |
| Mean Change in Revised Fibromyalgia Impact Questionnaire | The Revised Fibromyalgia Impact Questionnaire (FIQR) is a 21-item, three-domain, self-reported measure of the impact of fibromyalgia on life. All questions include a 0-10 scale, and different domains have different calculations (function domain divided by 3, overall impact domain divided by 1, symptom domain divided by 2) before summing all scores. The total score will be used to estimate the changes in quality of life with interventions. | Baseline and post-treatment (within 7 days of completing rTMS sessions). |
| Mean Change in Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) measures sleep quality over the past month and consists of seven components assessing various aspects of sleep quality and sleep-related daytime functioning. The index will be used to estimate the overall sleep quality of participants, with total scores ranging from 0 to 21, where higher scores indicate worse sleep quality. | Baseline and post-treatment (within 7 days of completing rTMS sessions). |
| Mean Change in Chronic Overlapping Pain Conditions Screener | Chronic Overlapping Pain Conditions Screener (COPCS) is a self-report tool that uses a body map and trigger questions to screen for 10 chronic overlapping pain conditions and outputs the number of conditions present (0-10). | Baseline and post-treatment (within 7 days of completing rTMS sessions). |
| Mean Change in Hospital Anxiety and Depression Scale | The Hospital Anxiety and Depression Scale (HADS) has 14 items, 7 each for anxiety and depression. Each item is rated 0-3, with subscale scores ranging 0-21; higher scores indicate greater symptom severity. | Baseline and post-treatment (within 7 days of completing rTMS sessions). |
| Mean Change in Beck Depression Inventory | The Beck Depression Inventory (BDI) has 21 items assessing depressive symptoms. Each item is rated 0-3, with total scores ranging 0-63; higher scores indicate greater depression severity. | Baseline and post-treatment (within 7 days of completing rTMS sessions). |
| Mean Change in Beck Anxiety Inventory | The Beck Anxiety Inventory (BAI) has 21 items assessing anxiety symptoms. Each item is rated 0-3, with total scores ranging 0-63; higher scores indicate greater anxiety severity. | Baseline and post-treatment (within 7 days of completing rTMS sessions). |
| D009422 |
| Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |