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Recruiting NCT06250491

NCT06250491 Deep rTMS (H-coil) for Neuropathic Pain or Fibromyalgia

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Clinical Trial Summary
NCT ID NCT06250491
Status Recruiting
Phase
Sponsor Nadine ATTAL
Condition Neuropathic Pain
Study Type INTERVENTIONAL
Enrollment 70 participants
Start Date 2024-01-30
Primary Completion 2027-01-30

Trial Parameters

Condition Neuropathic Pain
Sponsor Nadine ATTAL
Study Type INTERVENTIONAL
Phase N/A
Enrollment 70
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2024-01-30
Completion 2027-01-30
Interventions
Deep active rTMS with Hesed coilSham rTMS with Hesed coil

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Brief 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 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

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