Clinical trial NCT06250491: Deep rTMS (H-coil) for Neuropathic Pain or Fibromyalgia
Official title: Effects of Deep rTMS in Neuropathic Pain or Fibromyalgia : a Bicenter Randomized Sham Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuropathic Pain
Fibromyalgia
Lead sponsor: Hospital Ambroise Paré Paris
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Effects of rTMS versus sham rTMS on pain relief at 13 weeks
timeFrame: 13 weeks
Secondary outcomes:
measure: Effects of rTMS vs sham on average pain intensity
timeFrame: Each follow up visit at the pain center for up to 13 weeks
measure: Effects of rTMS vs sham on pain interference
timeFrame: Baseline then each follow up visit at the pain center for up to 13 weeks
measure: Effects of rTMS vs sham on quality of life
timeFrame: Baseline then each follow up vist at the pain center for up to 13 weeks
measure: Side effects of rTMS or sham
timeFrame: Each follow up visit at the pain center for up to 13 weeks
measure: Comparison of the efficacy of rTMS on the primary outcome between patients with neuropathic pain and fibromyalgia
timeFrame: Week 13
measure: Blinding assessment
timeFrame: 13 weeks
measure: Patient global impression of change
timeFrame: 13 weeks
measure: Self-reported pain intensity
timeFrame: Baseline then every day at the same time of day (morning or evening)
measure: Effects of rTMS versus sham on anxiety and depressive symptoms
timeFrame: Baseline then each follow up visit at the pain center for up to 13 weeks
measure: Effects of rTMS vs sham on pain as its worst from Brief Pain Inventory
timeFrame: Baseline then each follow up visit at the pain center for up to 13 weeks
measure: Effects of rTMS vs sham on pain as its least from Brief Pain Inventory
timeFrame: Baseline then each follow up visit at the pain center for up to 13 weeks
measure: Effects of rTMS vs sham on sleep
timeFrame: Baseline then each follow up visit at the pain center for up to 13 weeks
measure: Effects of rTMS vs sham on pain right now from Brief Pain Inventory
timeFrame: Baseline then each follow up visit at the pain center for up to 13 weeks
measure: Effects on Global Impression of change assessed by the clinician
timeFrame: 13 weeks (end of the treatment)
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Inserm U987
city: Paris
country: France
facility: Centre d'Evaluation et de Traitement de la douleur
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nadine ATTAL
role: STUDY_DIRECTOR
References: