Multisite rTMS for fibromyalgia with depressive symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, sham-controlled trial conducted at a single center. Participants with fibromyalgia, chronic pain, and mood symptoms will receive daily high-frequency rTMS over 5 days, followed by weekly and then biweekly sessions for about 2 months. Brain MRI-based neuronavigation guides coil placement, and outcomes include pain, mood, and neurophysiological measures collected at baseline, after the 5-day treatment, and at a 2-week follow-up. Analgesic response will be analyzed in relation to clinical and electrophysiological changes to identify predictors of efficacy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hopital Ambroise-Paré INSERM U987, 9 Av. Charles de Gaulle
  Boulogne-Billancourt, Île-de-France Region, France Recruiting

Study contacts

• Study coordinator: Nadine ATTAL
• Email: nadine.attal@aphp.fr
• Phone: +33 1 49 09 59 31

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Emotional Allodynia in Fibromyalgia: AEQ Validation

  This study tests whether the Emotional Allodynia Questionnaire (AEQ) reliably identifies emotional overreaction to social cues in adults with fibromyalgia compared with other chronic pain patients.

  Recruiting University of Bari · Bari and 4 other locations · NCT07677631

• Understanding subtypes of chronic musculoskeletal pain in youth

  This observational study tests whether distinct brain and immune profiles can explain chronic musculoskeletal pain in teens and young adults to guide more precise treatments.

  Recruiting Children's Hospital Medical Center, Cincinnati · Cincinnati, Ohio · NCT07602595

• Creating a Korean cohort to track cognitive aging

  This project will use smartphone surveys, a wearable watch, and blood tests to see if daily emotional stress is linked to short- and long-term thinking problems and inflammation in adults 60 and older in Seoul.

  Recruiting Korea University · Seoul, Select One... · NCT07485387

• Shiatsu therapy for long-lasting non-inflammatory pain in children and teens

  This study will try weekly 30-minute Shiatsu sessions alongside regular care to see if they improve quality of life for children and adolescents (ages 10–18) with non-inflammatory chronic pain.

  Recruiting Tel Aviv University · Tel Aviv, Tel Aviv and 1 other locations · NCT06929598

• Comparing two physiotherapy approaches for fibromyalgia

  This study tests whether a new physiotherapy program that includes education and personalized exercises can help people with fibromyalgia feel less pain and function better compared to standard physiotherapy.

  Recruiting Al Hayah University In Cairo · Cairo · NCT06913868

• Modulating brain alpha rhythms to improve attentional control

  This research will try an open-loop sham neurofeedback setup in adults with rumination or chronic pain (including fibromyalgia) to see if positive or negative feedback in virtual reality changes EEG alpha rhythms linked to attention.

  Recruiting National Council of Scientific and Technical Research, Argentina · Oro Verde, Entre Ríos Province · NCT06748976

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.