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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female and ages 18 +
. Ability to read/understand English and give consent to participate
. Physician diagnosis \& confirmation of primary fibromyalgia syndrome
Exclusion criteria
. If enrolled in psychotherapy, verbal agreement to maintain (not change or stop) the psychotherapy during the study
. Absence of use of opioid medications (during the previous 90 days, and no greater than a 30-day period during lifetime)
. limited ability to participate fully in behavioral tasks, longitudinal follow-up (e.g., plans to move out-of-state within 3 months)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pain Intensity
Timeframe: Baseline MRI and post-intervention MRI (approximately 3 weeks)
2
Change in Fatigue
Timeframe: Baseline MRI and post-intervention MRI (approximately 3 weeks)
3
Change in FMS-related brain/fibro fog as measured by the Montreal Cognitive Assessment (MoCA)
Timeframe: Baseline MRI and post-intervention MRI (approximately 3 weeks)
. MRI contraindication (e.g., metal implants, claustrophobia, pregnant or planning to become pregnant)
. any factors that at the discretion of the investigators would adversely affect the participant or the integrity of the study (e.g., ongoing legal action or disability claim regarding pain, uncontrolled psychiatric disorder, head/neck injury, use of certain medications)
. male \*
. current hypomania,
. meets diagnostic criteria for current psychotic disorder, or psychotic features,