RecruitingNot ApplicableNCT06250491

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

Effects of Deep rTMS in Neuropathic Pain or Fibromyalgia : a Bicenter Randomized Sham Controlled Study


Sponsor

Nadine ATTAL

Enrollment

70 participants

Start Date

Jan 30, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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 Criteria5

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

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Interventions

DEVICEDeep active rTMS with Hesed coil

This brain neurostimulation method targets the motor cortex bilaterally

DEVICESham rTMS with Hesed coil

This brain sham neurostimulation method targets the motor cortex bilaterally


Locations(2)

Inserm U987

Boulogne-Billancourt, France

Centre d'Evaluation et de Traitement de la douleur

Paris, France

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NCT06250491


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