NCT07642882Recruiting
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.
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 1 Jun 2026
- Start date
- Sept 2026
- Primary completion date
- Nov 2028
- Lead sponsor
- Hospital Ambroise Paré Paris
- Diseases
- Depression
- NCT number
- NCT07642882
What you commit to
- Study type: Interventional
- Planned participants: 36
- From Sept 2026 to the primary completion date, Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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);
- Participation in another research protocol within 30 days prior to inclusion.
Other illness
- 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.
- Epilepsy or a history of epilepsy;
- Unstable or progressive medical conditions (e.g., cancer);
- 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);
Other
- Ongoing litigation;
- Contraindication to rTMS:
- Pregnancy or breastfeeding;
- Psychosis according to DSM-5 criteria;
- Inability to understand the informed consent form, or subjects under legal guardianship or curatorship;
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Ambroise-Paré INSERM U987, 9 Av. Charles de Gaulle Coordinator of this site? Confirm its status | Boulogne-Billancourt | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.