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

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Description

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).

Study Overview

Start Date
January 30, 2024
Completion Date
April 30, 2027
Enrollment
100
Date Posted
February 9, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Inserm U987
Boulogne-Billancourt 92100, France

Eligibility

Minimum Age (years)
18
Maximum Age (years)
80
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

Study Contact Info

Study Contact Name
Nadine ATTAL
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
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.
NCTid (if applicable)
NCT06250491