Идёт набор NCT06250491

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

Без фазы С лечением Neuropathic Pain Fibromyalgia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Deep active rTMS with Hesed coil, Sham rTMS with Hesed coil.
Кому может быть актуально: Состояния в реестре: Neuropathic Pain, Fibromyalgia. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

Effects of rTMS versus sham rTMS on pain relief at 13 weeks [Срок оценки: 13 weeks]

Вторичные конечные точки (12)

Effects of rTMS vs sham on average pain intensity [Срок оценки: Each follow up visit at the pain center for up to 13 weeks]
Effects of rTMS vs sham on pain interference [Срок оценки: Baseline then each follow up visit at the pain center for up to 13 weeks]
Effects of rTMS vs sham on quality of life [Срок оценки: Baseline then each follow up vist at the pain center for up to 13 weeks]
Side effects of rTMS or sham [Срок оценки: 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 [Срок оценки: Week 13]
Blinding assessment [Срок оценки: 13 weeks]
Patient global impression of change [Срок оценки: 13 weeks]
Self-reported pain intensity [Срок оценки: Baseline then every day at the same time of day (morning or evening)]
Effects of rTMS versus sham on anxiety and depressive symptoms [Срок оценки: Baseline then each follow up visit at the pain center for up to 13 weeks]
Effects of rTMS vs sham on pain as its worst from Brief Pain Inventory [Срок оценки: 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 [Срок оценки: Baseline then each follow up visit at the pain center for up to 13 weeks]
Effects of rTMS vs sham on sleep [Срок оценки: Baseline then each follow up visit at the pain center for up to 13 weeks]

Критерии участия

Критерии включения

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