Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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);

Disqualifiers

Ongoing litigation;

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);

Trial design

Treatments tested in this trial

  • rTMS
  • Sham

Treatment groups

36 Participants
are divided into 2 treatment groups

Locations

1
Hopital Ambroise-Paré INSERM U987, 9 Av. Charles de Gaulle92100, Boulogne-BillancourtÎle-de-France Region, France

Sponsors and collaborators

Hospital Ambroise Paré Paris

Lead sponsor

Source ClinicalTrials.gov