An interventional study of Transcranial Magnetic Stimulation (TMS) in Fibromyalgia Syndrome, Fibromyalgia and Chronic Pain and Fatigue, sponsored by Duke University. Enrolling by invitation at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
This pilot feasibility study aims to evaluate transcranial magnetic stimulation (TMS) targeting the prefrontal cortex in patients with fibromyalgia syndrome (FMS). The study will assess preliminary efficacy and mechanisms of central nervous system changes using neuroimaging, behavioral tasks, sensory testing, and neuroimmune markers. Participants will undergo MRI scans, multi-day TMS sessions, and complete questionnaires. The goal is to generate pilot data for future trials on neuromodulation for chronic pain.
This is a study to compare activity in the brains of female adults with chronic pain before and after a new intervention. What the researchers learn by doing this study may help them understand how the brain works and how to develop new and targeted treatments for adults with chronic pain.
Female participants in this study will come to Duke Hospital for up to 6 visits. First, there is an MRI scan visit. Then, there are 4 intervention (TMS) visits, one after the other over 4 days. Next, there is an identical follow up MRI scan visit. Afterwards, there is a one month, three month, and six month follow up that can be completed remotely.
During each of 2 MRI study visits, participants will:
During each of 4 TMS study visits, participants will:
Participation is complete once the requested study visits and follow-up questionnaires have been completed.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusions:
TMS-Specific Exclusions:
1. TMS contraindication (e.g., history of seizures, medications contraindicated for risks/efficacy of TMS procedures)
pregnancy
Due to the contributions of hormones to the conditions under study in this project, female eligibility in this study will be defined as an individual who is female sex at birth and currently female sex
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive TMS over 4 consecutive days (20 sessions total).
Device: Transcranial Magnetic Stimulation (TMS)
TMS protocol delivered via MagPro X100 stimulator with figure-8 coil targeting prefrontal cortex.
Change in Pain Intensity
PROMIS Short Form - Pain Intensity (3a) is a 3-item measure which includes questions of pain at its worst (past 7 days), average pain (past 7 days), and pain right now (at time of survey). Each item is rated from No Pain (1) to Very Severe (5).
Time frame: Baseline MRI and post-intervention MRI (approximately 3 weeks)
Change in Fatigue
The PROMIS Fatigue Computer Adaptive Test (CAT) is a dynamic, patient-reported outcome tool that measures fatigue severity (intensity, frequency, and impact) over the past seven days. Using item response theory (IRT), it selects the next best question based on previous answers, typically requiring only 4-6 items to produce highly precise, reliable scores while minimizing patient burden. Scoring: Results are reported as T-scores, where 50 is the general population mean and 10 is the standard deviation. A T-score of 60 or higher is one standard deviation worse than average.
Time frame: Baseline MRI and post-intervention MRI (approximately 3 weeks)
Change in FMS-related brain/fibro fog as measured by the Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) is a valid, 30-point screening tool used to assess "fibro fog"-the cognitive dysfunction, memory loss, and attention difficulties associated with fibromyalgia. Scoring: The test is scored out of 30 points. A score of 26-30 is considered normal, while scores below 26 may indicate mild cognitive impairment (19-25) or more advanced impairment (below 21). One point is added for individuals with 12 years or fewer of formal education.
Time frame: Baseline MRI and post-intervention MRI (approximately 3 weeks)
Change in the brain's response to task stimuli
Functional Magnetic Resonance Imaging (fMRI) will be used to track blood-oxygen-level-dependent (BOLD) signals during reward anticipation and feedback. BOLD signal change identifies neural activity in the brain which will be reported as normalized to percent signal change (Avg%Δ) relative to the mean image intensity to allow for cross-subject comparison (i.e., arbitrary units scale).
Time frame: Baseline MRI and post-intervention MRI (approximately 3 weeks)
Change in the brain's cortico-striatal circuit functional connectivity
Functional connectivity in fMRI measures the statistical dependencies (similarities) between blood oxygen level-dependent (BOLD) signal time series from different brain regions. Typically quantified using Pearson's correlation or covariance in either resting-state or task-based studies, it identifies synchronized activity indicating functionally linked regions/networks.
Time frame: Baseline MRI and post-intervention MRI (approximately 3 weeks)
Ventral-dorsal spinal cord fMRI-indicated activity
Amplitude of Low-Frequency Fluctuations (ALFF) in fMRI measures the intensity of spontaneous brain activity by calculating the square root of the power spectrum (via Fast Fourier Transform) within a specific low-frequency range. It quantifies the amplitude of resting-state BOLD signal oscillations, typically after voxel-wise standardization (i.e., arbitrary units scale).
Time frame: Baseline MRI and post-intervention MRI (approximately 3 weeks)
Blood cytokine levels
Cytokines in blood, when measured using Meso Scale Discovery (MSD) multiplex immunoassay kits, are typically reported in picograms per milliliter (pg/mL). MSD assays are known for their high sensitivity, capable of detecting analytes in the low pg/mL to sub-pg/mL range.
Time frame: Baseline MRI and post-intervention MRI (approximately 3 weeks)
PEG Scale Change
The PEG scale (Pain, Enjoyment, General Activity) is a 3-item, patient-reported tool that measures chronic pain intensity and its interference with daily life. It uses a 0-10 numerical rating scale (NRS) for each item, where 0 represents "no pain/no interference" and 10 represents "worst pain/complete interference," averaging the three to produce a final score.
Time frame: Baseline MRI and post-intervention MRI (approximately 3 weeks)
Fibromyalgia Impact Questionnaire (FIQ-R) Change
The Fibromyalgia Impact Questionnaire (FIQ) and its revision (FIQR) measure the overall impact of fibromyalgia on a patient's life, including physical function, work difficulty, pain, fatigue, sleep quality, and psychological symptoms over the past 7 days. Total scores range from 0 to 100, with higher scores indicating greater severity.
Time frame: Baseline MRI and post-intervention MRI (approximately 3 weeks)
Plan to share: No — As this is a small feasibility trial and will not be published, we do not plan to share the data.
Started Jul 2026 (actual). Primary completion is estimated for Dec 2026, 5 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 5 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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