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

Nadine ATTAL

Status: Enrolling

Conditions: Fibromyalgia; Neuropathic Pain

Treatments: Device: Deep active rTMS with Hesed coil; Device: Sham rTMS with Hesed coil

Study type: Interventional

Funder types: Other

Identifiers

NCT06250491

2023-A00902-43

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Active rTMS

Experimental group

Description:

Deep rTMS with H coil targeting the motor cortex bilaterally

Treatment:

Device: Sham rTMS with Hesed coil

Device: Deep active rTMS with Hesed coil

Sham rTMS

Placebo Comparator group

Description:

Sham rTMS with H coil targeting the motor cortex bilaterally

Treatment:

Device: Sham rTMS with Hesed coil

Device: Deep active rTMS with Hesed coil