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

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

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

• Status: Recruiting
• Conditions: Fibromyalgia; Neuropathic Pain
• Intervention / Treatment: Device: Deep active rTMS with Hesed coil; Device: Sham rTMS with Hesed coil

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nadine ATTAL; Phone Number: 0033149095931; Email: nadine.attal@aphp.fr

Study Locations

• France
  • Boulogne-Billancourt, France, 92100
    • Recruiting
    • Inserm U987
    • Principal Investigator: Serge PERROT
    • Contact: Nadine ATTAL; Phone Number: 0033149095931; Email: nadine.attal@aphp.fr
    • Sub-Investigator: Didier BOUHASSIRA
  • Paris, France, 75014
    • Not yet recruiting
    • Centre d'Evaluation et de Traitement de la douleur
    • Contact: Serge PERROT; Email: serge.perrot@aphp.fr
    • Sub-Investigator: Anne-Priscille TROUVIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active rTMS; Deep rTMS with H coil targeting the motor cortex bilaterally	Device: Deep active rTMS with Hesed coil; This brain neurostimulation method targets the motor cortex bilaterally; Device: Sham rTMS with Hesed coil; This brain sham neurostimulation method targets the motor cortex bilaterally
Placebo Comparator: Sham rTMS; Sham rTMS with H coil targeting the motor cortex bilaterally	Device: Deep active rTMS with Hesed coil; This brain neurostimulation method targets the motor cortex bilaterally; Device: Sham rTMS with Hesed coil; This brain sham neurostimulation method targets the motor cortex bilaterally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of rTMS versus sham rTMS on pain relief at 13 weeks	Pain relief scale from the Brief Pain Inventory rated from 0 to 100 %	13 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nadine ATTAL
• Investigators: Study Director: Nadine ATTAL, Assistance Publique - Hopitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2024
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Neuropathic pain - Fibromyalgia - deep rTMS
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Fibromyalgia; Neuralgia
• Other Study ID Numbers: 2023-A00902-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No