Using deep rTMS to treat neuropathic pain and fibromyalgia
Effects of Deep rTMS in Neuropathic Pain or Fibromyalgia : a Bicenter Randomized Sham Controlled Study
NA · Hospital Ambroise Paré Paris · NCT06250491
This study is testing if a special type of brain stimulation can help people with neuropathic pain or fibromyalgia feel less pain over three months.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospital Ambroise Paré Paris (other) |
| Locations | 2 sites (Boulogne-Billancourt and 1 other locations) |
| Trial ID | NCT06250491 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of deep repetitive transcranial magnetic stimulation (rTMS) using an H-coil for patients suffering from neuropathic pain or fibromyalgia. It is a randomized, double-blind, sham-controlled trial lasting three months, where participants will receive either active or sham rTMS sessions. The treatment involves five daily sessions followed by weekly sessions, with a total of up to ten weeks of treatment. The primary outcome measure is the percentage of pain relief assessed at week 13.
Who should consider this trial
Good fit: Ideal candidates are adults with chronic neuropathic pain or fibromyalgia lasting at least six months and experiencing daily pain rated at 4/10 or higher.
Not a fit: Patients with contraindications to rTMS, prior rTMS treatment, or severe progressive conditions such as cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief for patients suffering from chronic neuropathic pain or fibromyalgia.
How similar studies have performed: Previous studies have shown promising results with rTMS for chronic pain conditions, suggesting potential efficacy for this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Chronic pain ≥ 6 months, at least 4/10 on a 0-10 NRS, present every day or nearly every day * Neuropathic pain (confirmed with Douleur Neuropathique en 4 questions and international criteria from NeuPSIG) or fibromyalgia (revised ACR criteria) * Stable concomitant medications for pain for at least one month * Able to fill out questionnaires and understand and speak French Exclusion Criteria: * Contraindications to rTMS * Prior treatment with rTMS * Progressive severe condition (eg cancer) * Psychosis * Psychoactive drug abuse
Where this trial is running
Boulogne-Billancourt and 1 other locations
- Inserm U987 — Boulogne-Billancourt, France (RECRUITING)
- Centre d'Evaluation et de Traitement de la douleur — Paris, France (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Nadine ATTAL
- Email: nadine.attal@aphp.fr
- Phone: 0033149095931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neuropathic Pain, Fibromyalgia, Neuropathic pain - Fibromyalgia - deep rTMS