Идёт набор NCT04936646

Study of RTMS Analgesic Effect in Chronic Neuropathic Pain,

Без фазы С лечением Chronic Neuropathic Pain

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: RepetitiveTranscranial Magnetic Stimulation (rTMS).
Кому может быть актуально: Состояния в реестре: Chronic Neuropathic Pain. 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

Randomized Double-blind Study of RTMS Analgesic Effect in Chronic Neuropathic Pain. Comparison Between Three Groups: Motor Cortex Stimulation by the Classic Coil B65, Deeper Stimulation by the Coil B70 and Placebo Stimulation. Analysis of Long-term RTMS-induced Brain Changes Using FMRI.

Обзор

The purpose of this study is to compare the analgesic effectiveness of three modes of repetitive Transcranial Magnetic Stimulation (rTMS) in chronic neuropathic pain: * Classical rTMS stimulation * Deeper rTMS stimulation * Sham rTMS stimulation

Подробное описание

Conduct of study:

* Entry into the study: After informed consent, patients will be randomised. The physician responsible for conducting neurostimulation sessions will make the randomization via an interactive web response system (IWRS). Only this physician will have the knowledge of the group allocated to the patient. * Baseline : Patients, will record on a diary form, a daily Visual Numeric Scale(VNS) of Pain Intensity for 1 week. * Treatment sessions: after the baseline, sessions of neurostimulation will begin for seven weeks. * After the end of neurostimulation sessions, patients will be followed for 2 weeks. * Throughout their participation in the study, patients will plot on a diary form their daily VNS.

Вмешательства

Устройство RepetitiveTranscranial Magnetic Stimulation (rTMS)
The rTMS protocol consist of one session per day for five days during the first week, then three sessions the second week and then one session the third week, followed by two monthly sessions.

Первичные конечные точки

Evolution of Pain. [Срок оценки: Pain progression will be assessed from week 1 (before treatment) to week 7 (end of treatment)]

Вторичные конечные точки (11)

Assesment of Potential Changes in Sensory-motor Cortical Maps Induced by rTMS [Срок оценки: Day 60 from the beginning of rTMS treatment compared to baseline.]
Rate of Responding Patients. [Срок оценки: week 7 compared with baseline]
Assessment of Overall Patient Improvement. [Срок оценки: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline]
Quality of Life Improvement. [Срок оценки: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline]
Evolution of Anxiety and Depressive Traits. [Срок оценки: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline]
Evolution of Symptomatological Profiles of Neuropathic Pain. [Срок оценки: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline.]
Sympathetic Autonomic System Injury and Small Fiber Neuropathy. [Срок оценки: Day 60 from the beginning of rTMS treatment compared to baseline.]
Autonomous System Assessement. [Срок оценки: Day 60 from the beginning of rTMS treatment compared to baseline.]
Evolution of the use of analgesic treatments. [Срок оценки: From baseline to day 60.]
Analgesic Response Analysis [Срок оценки: From baseline to day 60.]
Improvement of pain triggered by a stimulus (allodynia). [Срок оценки: Day 30 and day 60 from the beginning of rTMS treatment compared to baseline.]

Критерии участия

Критерии включения

Patient's written consent
Affiliated with social security system
Male or female, suffering for more than a year from unilateral refractory neuropathic pain: hemi-body, upper limb, lower limb and facial chronic pain.
Patient whose analgesic treatment, is stable for at least 1 month.
Patient not responding to conventional treatments
Prescreening EVN >3