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

Not Applicable

Recruiting

• Conditions: Neuropathic Pain; Fibromyalgia
• Interventions: Device: Deep active rTMS with Hesed coil; Device: Sham rTMS with Hesed coil

• Registration Number: NCT06250491
• Lead Sponsor: Nadine ATTAL

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).

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.

Study Timeline

• Study First Submitted: 2024-01-23
• Study Start: 2024-01-30
• Study First Submitted QC: 2024-01-31
• Status Verified: 2024-02
• Study First Posted: 2024-02-09
• Last Update Submitted: 2024-02-10
• Last Update Posted: 2024-02-13
• Primary Completion: 2027-01-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham rTMS	Deep active rTMS with Hesed coil	Sham rTMS with H coil targeting the motor cortex bilaterally
Active rTMS	Sham rTMS with Hesed coil	Deep rTMS with H coil targeting the motor cortex bilaterally
Active rTMS	Deep active rTMS with Hesed coil	Deep rTMS with H coil targeting the motor cortex bilaterally
Sham rTMS	Sham rTMS with Hesed coil	Sham rTMS with H coil targeting the motor cortex bilaterally

Primary Outcome Measures

Name	Time	Method
Effects of rTMS versus sham rTMS on pain relief at 13 weeks	13 weeks	Pain relief scale from the Brief Pain Inventory rated from 0 to 100 %

Secondary Outcome Measures

Name	Time	Method
Patient global impression of change	13 weeks	Patient global impression of change at 13 weeks (from much improved to much deteriorated)
Effects of rTMS versus sham on anxiety and depressive symptoms	Baseline then each follow up visit at the pain center for up to 13 weeks	Anxiety and depressive symptoms of the Hospital Anxiety and Depressive scale rated from 0 to 21 for anxiety and 0 to 21 for depression
Effects of rTMS vs sham on pain right now from Brief Pain Inventory	Baseline then each follow up visit at the pain center for up to 13 weeks	pain intensiy on 0-10 numerical rating scale
Effects of rTMS vs sham on average pain intensity	Each follow up visit at the pain center for up to 13 weeks	Average pain intensity from the Brief Pain Inventory rated from 0 to 10 on a 0-10 numerical pain scale
Self-reported pain intensity	Baseline then every day at the same time of day (morning or evening)	Average pain intensity from past 24 hours based on 0-10 numerical pain scale
Effects of rTMS vs sham on sleep	Baseline then each follow up visit at the pain center for up to 13 weeks	Sleep assessed using the sleep scale from the Medical Outcome Survey
Comparison of the efficacy of rTMS on the primary outcome between patients with neuropathic pain and fibromyalgia	Week 13	Comparison of both populations on the pain relief scale from the Brief Pain Inventory (0-100 %)
Effects of rTMS vs sham on pain as its least from Brief Pain Inventory	Baseline then each follow up visit at the pain center for up to 13 weeks	pain intensiy on 0-10 numerical rating scale
Blinding assessment	13 weeks	Blindinq questionnaire at 13 weeks(end of the study)
Effects on Global Impression of change assessed by the clinician	13 weeks (end of the treatment)	Clinician global impression of change (from much improved to much deteriorated)
Effects of rTMS vs sham on pain interference	Baseline then each follow up visit at the pain center for up to 13 weeks	pain interference from Brief Pain Inventory rated from 0 to 70 (total score)
Effects of rTMS vs sham on quality of life	Baseline then each follow up vist at the pain center for up to 13 weeks	Euroqol scale which includes 5 dimensions of quality of life and a 0-100 visual analog scale
Side effects of rTMS or sham	Each follow up visit at the pain center for up to 13 weeks	Any side effects reported by the patients assessed at each visit after each treatment session and rated as mild, moderate or severe
Effects of rTMS vs sham on pain as its worst from Brief Pain Inventory	Baseline then each follow up visit at the pain center for up to 13 weeks	pain intensity on 0-10 numerical rating scale

Trial Locations

Locations (2)

Inserm U987; 🇫🇷 Boulogne-Billancourt, France

Centre d'Evaluation et de Traitement de la douleur; 🇫🇷 Paris, France