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

Fibromyalgia Clinical Trial

— H-FINEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06250491
• Other study ID #: 2023-A00902-43
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: April 30, 2027

Study information

• Verified date: February 2024
• Source: Hospital Ambroise Paré Paris
• Contact: Nadine ATTAL
• Phone: 0033149095931
• Email: nadine.attal[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2027
• Est. primary completion date: January 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Neuralgia
• Neuropathic Pain

Intervention

Device:
• Deep active rTMS with Hesed coil
This brain neurostimulation method targets the motor cortex bilaterally
• Sham rTMS with Hesed coil
This brain sham neurostimulation method targets the motor cortex bilaterally

Locations

Country	Name	City	State
France	Inserm U987	Boulogne-Billancourt
France	Centre d'Evaluation et de Traitement de la douleur	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Nadine ATTAL

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Blinding assessment	Blindinq questionnaire at 13 weeks(end of the study)	13 weeks
Secondary	Patient global impression of change	Patient global impression of change at 13 weeks (from much improved to much deteriorated)	13 weeks
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)