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

Nadine ATTAL100 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Neuropathic Pain Fibromyalgia

Interventions

Deep active rTMS with Hesed coilDEVICE

This brain neurostimulation method targets the motor cortex bilaterally

Sham rTMS with Hesed coilDEVICE

This brain sham neurostimulation method targets the motor cortex bilaterally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Inserm U987

Boulogne-Billancourt, France

RECRUITING

Centre d'Evaluation et de Traitement de la douleur

Paris, France

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

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 %

Time frame: 13 weeks

Secondary Outcomes

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

Time frame: 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)

Time frame: Baseline then each follow up visit at the pain center for up to 13 weeks

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

Time frame: Baseline then each follow up vist 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

Time frame: 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 %)

Time frame: Week 13

Blinding assessment

Blindinq questionnaire at 13 weeks(end of the study)

Central Contacts

Nadine ATTAL

CONTACT

0033149095931 nadine.attal@aphp.fr

Data from ClinicalTrials.gov

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