Effects of Deep rTMS in Neuropathic Pain or Fibromyalgia : a Bicenter Randomized Sham Controlled Study
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
Inserm U987
RECRUITING
Boulogne-billancourt
Centre d'Evaluation et de Traitement de la douleur
NOT_YET_RECRUITING
Paris
Contact Information
Primary
Nadine ATTAL
nadine.attal@aphp.fr
0033149095931
Time Frame
Start Date: 2024-01-30
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 100
Treatments
Experimental: Active rTMS
Deep rTMS with H coil targeting the motor cortex bilaterally
Placebo_comparator: Sham rTMS
Sham rTMS with H coil targeting the motor cortex bilaterally
Related Therapeutic Areas
Sponsors
Leads: Nadine ATTAL