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.
• 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.