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: * Have a urine test for drug use (and pregnancy if applicable) * Have a blood draw to measure inflammation and/or genetic testing * Have magnetic resonance imaging (MRI) scans of the brain and spine * Complete behavior tests (participate in games or tasks), sensory tests, and questionnaires During each of 4 TMS study visits, participants will: * Have brief transcranial magnetic stimulation (TMS) applied to the head * Complete behavior tests (participate in games or tasks), sensory tests, and questionnaires Participation is complete once the requested study visits and follow-up questionnaires have been completed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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).
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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)