rTMS Efficacy Coupled With Mirror Therapy

Официальное название

Clinical Study of Repetitive Transcranial Magnetic Stimulation (RTMS) Efficacy Coupled With Mirror Therapy for Neuropathic Pain Relief

Обзор

Neuropathic pain is particularly difficult to treat with classic first-line drugs. Neuromodulation techniques using repetitive transcranial magnetic stimulation (rTMS) are useful alternative, but there is a need to improve their analgesic effect.Virtual reality mirror therapy has shown the capacity to alleviate pain and may be easily coupled with rTMS.The present project will investigate in individuals with neuropathic pain the effects of the rTMS coupled with virtual reality mirror therapy.

Подробное описание

This project introduces a new research question that incorporates virtual reality mirror therapy into an established treatment protocol of repetitive transcranial magnetic stimulation (rTMS) for neuropathic pain relief. Neuropathic pain is particularly difficult to treat with classic first-line drugs. Neuromodulation techniques using repetitive transcranial magnetic stimulation (rTMS) are useful alternative, but there is a need to improve their analgesic effect.

Virtual reality mirror therapy has shown the capacity to alleviate pain and may be easily coupled with rTMS. The efficacy of using both techniques in neuropathic pain treatment is unknown. The present project will investigate in individuals with neuropathic pain the effects of the rTMS coupled with virtual reality mirror therapy on: 1) daily pain intensity (i.e. analgesic efficacy); 2) other components of pain and the quality of life; 3) brain activity.

It will be the first to provide insight into the efficacy of using together both non-invasive technics of cortical neuromodulation to alleviate pain.

Вмешательства

• Другое Repetitive transcranial magnetic stimulation (rTMS)
  20 minutes of high frequency (20Hz) rTMS.
• Другое Mirror therapy using virtual reality
  active mirror-based therapy
• Другое Mirror therapy using sham mirror
  20 minutes of sham mirror-based therapy

Первичные конечные точки

• Pain intensity measurement [Срок оценки: Week 9]

Вторичные конечные точки (4)

• Quality of life after treatment [Срок оценки: week 12]
• Spontaneous brain activity [Срок оценки: week 12]
• neuropathic dimension [Срок оценки: Week 3, 5, 7, 9,12]
• Adverse events [Срок оценки: Week 3, 5, 7, 9,12]

Критерии участия

Критерии включения

• Clinical symptoms typical of neuropathic pain
• Refractory to drug therapies
• Lasting for at least 6 months, with a moderate to severe pain intensity (≥4/10 on Visual Analog Scale, VAS) and a stable pain treatment since 1month at least
• Having right to health benefits

Критерии исключения

• Ferromagnetic components and implanted microprocessors (i.e. cochlear implants)
• Drug-resistant or active epilepsy, pacemaker, pregnancy, ongoing depression or personality troubles, and ongoing opioid treatment.
• Any other contraindications to MRI scanner (e.g., claustrophobia, etc.).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Франция · 2 центра

• Hôpital Neurologique Pierre Wertheimer — Bron
• Centre Hospitalier Universitaire de Saint-Etienne — Saint-Etienne

Идентификаторы

NCT: NCT04867187 · 21CH035 · 2021-A00720-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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