Magnetic stimulation of the brain for pain in fibromyalgia, with or without depression
Tests magnetic brain stimulation against a sham for fibromyalgia pain, with or without depression.
Plain-language title generated from the registry record
Registry title: Analgesic Efficacy of Multisite rTMS in Fibromyalgia Patients
Key facts
- Where
- Boulogne-Billancourt, FranceSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07642882, who can take part
Where in France
- Hopital Ambroise-Paré INSERM U987, 9 Av. Charles de GaulleBoulogne-Billancourt, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Ambroise Paré Paris
- Trial code
- NCT07642882
- Record updated
- 11 June 2026
- Original description
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.Read full original descriptionShow less
Analgesic Efficacy of Multisite rTMS in Depressed and Nondepressed Patients With Fibromyalgia and Prediction of the Response: a Double-Blind Randomized Sham-Controlled Study.
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.
Inclusion: 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: 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, stents, or bullet fragments); Current abuse of drugs or psychoactive substances, including alcohol (according to DSM-5 criteria); Participation in another research protocol within 30 days prior to inclusion; 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; Epilepsy or a history of epilepsy; Unstable or progressive medical conditions (e.g., cancer); Presence of another pain condition more severe than the one qualifying for inclusion; Failure to correctly complete pain self-assessment diaries between inclusion and randomization (fewer than 4 pain scores recorded over 7 days); Ongoing litigation; Contraindication to rTMS:; Pregnancy or breastfeeding; Psychosis according to DSM-5 criteria; Inability to understand the informed consent form, or subjects under legal guardianship or curatorship.