Recruiting

Analgesic Efficacy of Multisite rTMS in Fibromyalgia Patients

ClinicalTrials.gov IDNCT07642882

PhaseNA

Enrollment36

SponsorHospital Ambroise Paré Paris

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Fibromyalgia, Depression - Major Depressive Disorder, Chronic Pain

About this 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.

Interventions

Device: rTMS — The active protocol will include 5 daily stimulation sessions during the first week (D1-D5), followed by one session per week for 3 weeks (W2, W3, W4), then 2 sessions spaced 2 weeks apart (W6, W8), for a total of 10 stimulation sessions. Evaluation will continue until 2 weeks after the final stimulation, that is, at week 10 after the start of treatment.
Device: Sham — The sham protocol will follow an identical session schedule. Participants will be randomized to either the active or sham group in a parallel-group design, meaning each participant will receive only one of the two treatments throughout the entire duration of the study.

Primary outcomes

Change in average pain intensity over 10 weeks (Brief Pain Inventory) (From enrollment to Week 10.)

Eligibility information

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, stents, or bullet fragments); * Current abuse of drugs or psychoactive substances, including alcohol (according to DSM-5 criteria); * Pregnancy or breastfeeding; * Epilepsy or a history of epilepsy; * Unstable or progressive medical conditions (e.g., cancer); * Psychosis according to DSM-5 criteria; * 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); * Inability to understand the informed consent form, or subjects under legal guardianship or curatorship; * Participation in another research protocol within 30 days prior to inclusion.

Study locations

Hopital Ambroise-Paré INSERM U987, 9 Av. Charles de Gaulle, Boulogne-Billancourt, Île-de-France Region 92100 France

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.