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

Last updated: February 10, 2024
Sponsor: Nadine ATTAL
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain (Pediatric)

Oral Facial Pain

Pain

Treatment

Sham rTMS with Hesed coil

Deep rTMS with Hesed coil

Deep active rTMS with Hesed coil

Clinical Study ID

NCT06250491
2023-A00902-43
  • Ages 18-80
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Chronic pain ≥ 6 months, at least 4/10 on a 0-10 NRS, present every day or nearlyevery day
  • Neuropathic pain (confirmed with Douleur Neuropathique en 4 questions andinternational 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

Exclusion Criteria:

  • Contraindications to rTMS
  • Prior treatment with rTMS
  • Progressive severe condition (eg cancer)
  • Psychosis
  • Psychoactive drug abuse

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: Sham rTMS with Hesed coil
Phase:
Study Start date:
January 30, 2024
Estimated Completion Date:
April 30, 2027

Study 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.

Connect with a study center

  • Inserm U987

    Boulogne-Billancourt, 92100
    France

    Active - Recruiting

  • Centre d'Evaluation et de Traitement de la douleur

    Paris, 75014
    France

    Site Not Available

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