An interventional study of rTMS in Fibromyalgia (FM), sponsored by University of Rochester. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by University of Rochester · Not applicable, Interventional, and Other
Among 369 studies in Fibromyalgia with a site in United States — 52 open to participants now, 63 under way, 2 of them phase 3. Fibromyalgia · United States.
Among the 369 studies in Fibromyalgia with a site in United States, this one is the 268th largest by planned enrollment of the 320 interventional ones that give a count, is one of 12 that started in 2025, is one of 167 with no phase, reaches primary completion later than 22 of the 62 other live ones, and was the 350th registered.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
Browse Fibromyalgia studies →52 of the 369 studies in Fibromyalgia with a site in United States are open now. Recruiting first, the newest first:
University of North Carolina, Chapel Hill · Sites in United States
Children's Hospital Medical Center, Cincinnati · Sites in United States
Spaulding Rehabilitation Hospital · Sites in United States
Pulkit Grover · Sites in United States
Theranica · Sites in United States, Israel
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 160 Fibromyalgia studies recruiting now, 50 (31%) set no upper age limit and 96 (60%) stop at 75 or younger; 14 take children under 18; 35 take healthy volunteers.
This study: 18 Years to 65 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
369 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 23 · Phase 2 61 · Phase 3 64 · Phase 4 24
First in 1994; this study’s year is marked. 12 started in 2025.
This study's planned enrollment of 20 is below the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Median enrollment 72 across the 320 interventional studies, 200 across the 47 observational. Of the 276 that completed or were terminated, 116 (42%) have results posted.
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101 of 369 have an industry lead sponsor. The 10 most frequent:
University of Rochester is the lead sponsor of 729 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
University of Rochester has 1 study filed under Fibromyalgia — fewer than ten, so there is no comparison to draw.
29 of the studies in Fibromyalgia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02979574Memorial Sloan Kettering Cancer CenterPEACE: Comparing Chronic Pain Treatment Options | 2026-11 |
| NCT07116278University of California, San FranciscoTMS-EEG Biomarkers for Chronic Pain | 2026-12 |
| NCT04949100Paul CrawfordMicrocurrent for Fibromyalgia | 2026-12 |
| NCT07525063Duke UniversityPain & Reward Neuromodulation of CNS Circuits | 2026-12 |
| NCT06552728University of California, IrvineThe Effects of Energy Healing in Fibromyalgia | 2026-12 |
Among the 369 studies in Fibromyalgia with a site in United States, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: rTMS
Other: rTMS
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.
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).
Time frame: Baseline and post-treatment (after 10 sessions of rTMS over 2 weeks).
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.
Time frame: Baseline and post-treatment (following 10 rTMS sessions, within 7 days of completing rTMS sessions ).
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and post-treatment (within 7 days of completing rTMS sessions).
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Jan 2027, 13 months after the start.
Of 436 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 13 months is below that.
Counting every sponsor, half of 449 studies reached it within 15 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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