Deep rTMS (H-coil) for Neuropathic Pain or Fibromyalgia
Recruiting · NCT06250491 · Interventional (participants receive a specific treatment) · Lead sponsor: Nadine ATTAL
View the official record on ClinicalTrials.gov →Interventions studied
Deep active rTMS with Hesed coilSham rTMS with Hesed coil
What this trial is about
This study will investigate the efficacy and safety of "deep" rTMS on neuropathic pain or fibromyalgia. It will be randomized and sham controlled and will last 3 months. Patients will be randomized to receive acctive rTMS or sham rTMS and will receive repeated rTMS sessions (5 daily sessions then one session per week then every 2 to 3 weeks for up to 10 weeks).
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
2 locations listed.
- Inserm U987 - Boulogne-Billancourt, France
- Centre d'Evaluation et de Traitement de la douleur - Paris, France