Deep rTMS (H-coil) for Neuropathic Pain or Fibromyalgia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deep active rTMS with Hesed coil, Sham rTMS with Hesed coil.
- Who it may be relevant to
- Registry conditions: Neuropathic Pain, Fibromyalgia. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Deep rTMS in Neuropathic Pain or Fibromyalgia : a Bicenter Randomized Sham Controlled Study
Overview
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).
Detailed description
This double blind sham controlled parallel group bicenter study will assess the efficacy and safety of repeated sessions of deep rTMS using H coil in patients with neuropathic pain or fibromyalgia. Primary outcome will be % of pain relief at week 13.
Interventions
- Device Deep active rTMS with Hesed coil
This brain neurostimulation method targets the motor cortex bilaterally - Device Sham rTMS with Hesed coil
This brain sham neurostimulation method targets the motor cortex bilaterally
Primary outcome measures
- Effects of rTMS versus sham rTMS on pain relief at 13 weeks [Time frame: 13 weeks]
Secondary outcome measures (12)
- Effects of rTMS vs sham on average pain intensity [Time frame: Each follow up visit at the pain center for up to 13 weeks]
- Effects of rTMS vs sham on pain interference [Time frame: Baseline then each follow up visit at the pain center for up to 13 weeks]
- Effects of rTMS vs sham on quality of life [Time frame: Baseline then each follow up vist at the pain center for up to 13 weeks]
- Side effects of rTMS or sham [Time frame: Each follow up visit at the pain center for up to 13 weeks]
- Comparison of the efficacy of rTMS on the primary outcome between patients with neuropathic pain and fibromyalgia [Time frame: Week 13]
- Blinding assessment [Time frame: 13 weeks]
- Patient global impression of change [Time frame: 13 weeks]
- Self-reported pain intensity [Time frame: Baseline then every day at the same time of day (morning or evening)]
- Effects of rTMS versus sham on anxiety and depressive symptoms [Time frame: Baseline then each follow up visit at the pain center for up to 13 weeks]
- Effects of rTMS vs sham on pain as its worst from Brief Pain Inventory [Time frame: Baseline then each follow up visit at the pain center for up to 13 weeks]
- Effects of rTMS vs sham on pain as its least from Brief Pain Inventory [Time frame: Baseline then each follow up visit at the pain center for up to 13 weeks]
- Effects of rTMS vs sham on sleep [Time frame: Baseline then each follow up visit at the pain center for up to 13 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
France · 2 centers
- Inserm U987 — Boulogne-Billancourt
- Centre d'Evaluation et de Traitement de la douleur — Paris
Identifiers
NCT: NCT06250491 · 2023-A00902-43