RecruitingNot Applicable

Analgesic Efficacy of Multisite rTMS in Fibromyalgia Patients

France36 participantsStarted 2026-09

Plain-language summary

Repetitive Transcranial Magnetic Stimulation (rTMS) of the motor cortex is a recognized analgesic technique for the treatment of fibromyalgia pain, which represents a largely unmet medical need. However, the effectiveness of motor cortex rTMS is inconsistent, being observed in only about 40% of patients and not always long-lasting. It has been previously shown that predictive factors for a lack of response to motor cortex rTMS include the presence of depressive symptoms, and that prefrontal cortex rTMS is not effective for pain, even though this treatment has proven efficacy in major depressive disorder. The hypothesis is that targeting both the motor and prefrontal cortices with rTMS will yield a particularly beneficial effect in fibromyalgia patients presenting with comorbid depressive symptoms. Given the absence of established biomarkers for predicting rTMS response, an additional aim will be to develop reliable indicators of rTMS efficacy, based on clinical phenotype and measurements of oscillatory patterns assessed by electroencephalogram (EEG) recordings.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

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: * Chronic pain lasting at least 6 months, with or without associated depressive symptoms; * Fibromyalgia (2016 revised ACR criteria and a FIRST questionnaire score of at least 5 out of 6); * Average pain intensity ≥ 4/10 on a 0-10 numeric rating scale; * Pain present daily or almost daily (≥ 4 days per week); * Patients aged over 18 and under 80 years; * Patients who have provided written informed consent; * Patients whose analgesic treatment has been stable for at least 1 month prior to inclusion and will not need to be modified during the study; * Patients who can be followed for the duration of the study (10 weeks); * Patients covered by a health insurance plan or otherwise eligible. Exclusion Criteria: * Ongoing litigation; * Contraindication to rTMS: * Implanted electronic devices and/or conductive objects near the coil: Patients with an active implanted device that is activated or controlled by physiological signals (e.g., pacemakers, implantable cardiac defibrillators \[ICD\], vagus nerve stimulators \[VNS\], wearable cardioverter defibrillators \[WCD\], ocular implants, deep brain stimulation systems, drug infusion pumps or ports, intracardiac leads), even if the device has been removed. * Non-removable metallic objects near the coil:\*\* Patients with a conductive, ferromagnetic, or magnetically sensitive metal implant in the head or within 30 cm of the coil (e.g., cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, st…

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.

1This trial uses repetitive transcranial magnetic stimulation — rTMS — at multiple sites on the brain to try to reduce fibromyalgia pain over 10 weeks. How does that approach compare to treatments I'm already considering, and is there any reason my situation might make it a better or worse fit?
2The trial is listed as Phase NA, which often means it's studying a technique or device rather than a drug. What does that mean for how much is already known about safety and effectiveness, and what should I realistically expect going in?
3The study is measuring changes in average pain intensity using something called the Brief Pain Inventory over 10 weeks. Is 10 weeks long enough to know whether this kind of treatment is actually working for someone with my history of fibromyalgia?
4This trial also includes people with major depressive disorder alongside chronic pain and fibromyalgia. If I have depression as well, does that change how my doctor would interpret whether I'm a good candidate to discuss this trial with?
5Since rTMS requires multiple in-person sessions, what does the typical weekly time commitment look like, and is that kind of schedule realistic given everything else I'm managing with my condition?

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

Change in average pain intensity over 10 weeks (Brief Pain Inventory)

Timeframe: From enrollment to Week 10.

Trial details

NCT IDNCT07642882

SponsorHospital Ambroise Paré Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-11

Contact for this trial

Nadine ATTAL

+33 1 49 09 59 31 nadine.attal@aphp.fr

View on ClinicalTrials.gov More Fibromyalgia trials