[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642658":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":58,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Hospital Ambroise Paré Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active rTMS of motor and prefrontal cortex","EXPERIMENTAL","Each rTMS session for each cortical target will include 30 trains of pulses delivered at 10 Hz for 10 seconds (100 pulses per train), with a 20-second interval between each train, resulting in a total of 3,000 pulses per session. The total duration will be 15 to 20 minutes per target, and 30 to 40 minutes for both cortical targets combined.\n\nThe stimulation intensity for the left motor cortex will be set at 80% of the resting motor threshold, defined as the minimal stimulation intensity that induces an electromyographic response of ≥50 µV in the first dorsal interosseous muscle of the hand, contralateral to the stimulated hemisphere, in at least 5 out of 10 trials.\n\nFor stimulation of the left prefrontal cortex, we will use a stimulation intensity of 120% of the motor threshold, as is customary in psychiatry and as in our previous studies on analgesia (Attal et al., 2021).",[13],"Device: rTMS",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham rTMS of motor and prefrontal cortex","SHAM_COMPARATOR","To perform the rTMS, a figure-of-eight Cool-B65 A\u002FP coil (MagVenture) will be used. This coil features a symmetrical design with two indistinguishable faces-one for active stimulation and the other for sham stimulation. The side used for each rTMS session will be determined by a personalized USB key for each patient, which will be connected to the rTMS device. The sound emitted during stimulation will be identical regardless of the side of the coil used.\n\nFinally, to further strengthen the treatment blinding for both the patient and the operator, the scalp-tapping sensation induced by active rTMS will be mimicked by low-intensity electrical stimulation applied to the head via surface electrodes. This electrical stimulation will be synchronized with the magnetic pulses during both active and sham stimulation sessions.",[19],"Device: Sham",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Nadine ATTAL","CONTACT","+33 1 49 09 59 31","nadine.attal@aphp.fr",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Elisa UMMARINO","+33 1 49 09 45 56","elisa.ummarino@inserm.fr",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Hopital Ambroise-Paré INSERM U987, 9 Av. Charles de Gaulle","RECRUITING","Boulogne-Billancourt","Île-de-France Region","92100","France","FR",{"type":51,"coordinates":52},"Point",[53,54],2.24128,48.83545,{"lat":54,"lon":53},[57],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":59,"investigatorFullName":33,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Coordinator","100642658","analgesic-efficacy-of-multisite-rtms-in-fibromyalgia-patients-100642658",false,"NCT07642882","Analgesic Efficacy of Multisite rTMS in Fibromyalgia Patients","Analgesic Efficacy of Multisite rTMS in Depressed and Nondepressed Patients With Fibromyalgia and Prediction of the Response: a Double-Blind Randomized Sham-Controlled Study.","MultiStimFM","Inclusion Criteria:\n\n* Chronic pain lasting at least 6 months, with or without associated depressive symptoms;\n* Fibromyalgia (2016 revised ACR criteria and a FIRST questionnaire score of at least 5 out of 6);\n* Average pain intensity ≥ 4\u002F10 on a 0-10 numeric rating scale;\n* Pain present daily or almost daily (≥ 4 days per week);\n* Patients aged over 18 and under 80 years;\n* Patients who have provided written informed consent;\n* 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;\n* Patients who can be followed for the duration of the study (10 weeks);\n* Patients covered by a health insurance plan or otherwise eligible.\n\nExclusion Criteria:\n\n* Ongoing litigation;\n* Contraindication to rTMS:\n* Implanted electronic devices and\u002For 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.\n* 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\u002Fstimulators, aneurysm clips or coils, stents, or bullet fragments);\n* Current abuse of drugs or psychoactive substances, including alcohol (according to DSM-5 criteria);\n* Pregnancy or breastfeeding;\n* Epilepsy or a history of epilepsy;\n* Unstable or progressive medical conditions (e.g., cancer);\n* Psychosis according to DSM-5 criteria;\n* Presence of another pain condition more severe than the one qualifying for inclusion;\n* Failure to correctly complete pain self-assessment diaries between inclusion and randomization (fewer than 4 pain scores recorded over 7 days);\n* Inability to understand the informed consent form, or subjects under legal guardianship or curatorship;\n* Participation in another research protocol within 30 days prior to inclusion.","ALL","18 Years","80 Years",{"count":73,"type":74},36,"ESTIMATED","INTERVENTIONAL",[77],"NA","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.\n\nThe 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.\n\nGiven 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.",[80,81,82],"Fibromyalgia","Depression - Major Depressive Disorder","Chronic Pain",[80,82,23,84,85,86],"Depression","Neuromodulation","EEG","2026-06-08",{"date":89,"type":90},"2026-06-11","ACTUAL",{"date":92,"type":74},"2026-09",{"date":94,"type":74},"2028-11",{"name":5,"class":6},1]