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Deep rTMS (H-coil) for Neuropathic Pain or Fibromyalgia

Deep rTMS (H-coil) for Neuropathic Pain or Fibromyalgia

Recruiting
18-80 years
All
Phase N/A

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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).

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.

Eligibility

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

Study details
    Neuropathic Pain
    Fibromyalgia

NCT06250491

Nadine ATTAL

21 February 2024

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