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RECRUITING

NCT07642882

Analgesic Efficacy of Multisite rTMS in Fibromyalgia Patients

Sponsor: Hospital Ambroise Paré Paris

View on ClinicalTrials.gov

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.

Official title: Analgesic Efficacy of Multisite rTMS in Depressed and Nondepressed Patients With Fibromyalgia and Prediction of the Response: a Double-Blind Randomized Sham-Controlled Study.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-09

Completion Date

2028-11

Last Updated

2026-06-11

Healthy Volunteers

Conditions

Fibromyalgia Depression - Major Depressive Disorder Chronic Pain

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.

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.

Locations (1)

Hopital Ambroise-Paré INSERM U987, 9 Av. Charles de Gaulle

Boulogne-Billancourt, Île-de-France Region, France