Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Active repetitive transcranial magnetic stimulation, Sham repetitive transcranial magnetic stimulation.
- Кому может быть актуально
- Состояния в реестре: Peripheral Neuropathy. Базовые параметры: от 18 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
- Польша
- 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
Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Pain Related to Peripheral Neuropathy
Обзор
Peripheral neuropathy is a frequent condition, commonly associated with pain. Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive method of modulation of brain plasticity and is regarded as one of alternative methods to alleviate pain associated with various kind of neuropathies. rTMS is usually performed once a day and the whole therapy of neuropathic pain lasts one week. In a number of recent clinical trials including patients with depression and some other disorders, rTMS was delivered several times a day, which reduced the time of the whole therapy. This approach was termed an accelerated rTMS. The purpose of this study is to investigate feasibility of accelerated rTMS in treatment of neuropathic pain.
Подробное описание
Peripheral neuropathy is a frequent condition, commonly associated with pain, which is often drug resistant. Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive method of modulation of brain plasticity. In this method, series of magnetic stimuli are delivered to the cerebral cortex, where they turn to electric current and depolarize repetitively the targeted neurons. If the stimulation is repeated during subsequent days it is capable to modify the activity of targeted cortical area for weeks or even months and by this way to achieve therapeutic effect. rTMS is most commonly used to treat drug-resistant depression but a number of other psychiatric and neurologic conditions is increasingly being regarded as therapeutic indication for rTMS. In patients suffering from neuropathic pain rTMS is delivered with high frequency, over primary motor areas (PMA). Stimulation of PMA should result in modulation of thalamic activity, achieved by antidromic excitation of thalamocortical connections. rTMS is usually performed once a day and the whole therapy of neuropathic pain lasts one week. In a number of recent clinical trials including patients with depression and some other disorders, rTMS was delivered several times a day, which reduced the time of the whole therapy. This approach was termed an accelerated rTMS. The purpose of this study is to investigate feasibility of accelerated rTMS in treatment of neuropathic pain.
Вмешательства
- Устройство Active repetitive transcranial magnetic stimulation
High frequency rTMS over the primary motor area to induce the long term potentiation of primary motor areas for the muscles of upper extremity. - Устройство Sham repetitive transcranial magnetic stimulation
Sham stimulation to mimic the high frequency rTMS over the primary motor area.
Первичные конечные точки
- Visual Analogue Scale of Pain Severity after rTMS [Срок оценки: Through study completion, an average of 1 year.]
- Visual Analogue Scale of Pain Severity First Follow-up [Срок оценки: Before rTMS, up to one day after finishing rTMS.]
- Visual Analogue Scale of Pain Severity Second Follow-up [Срок оценки: Before rTMS, four weeks after finishing rTMS.]
Вторичные конечные точки (12)
- Numeric Pain Severity Scale after rTMS [Срок оценки: Before rTMS, up to one day after finishing rTMS.]
- Numeric Pain Severity Scale First Follow-up [Срок оценки: Before rTMS, two weeks after finishing rTMS.]
- Numeric Pain Severity Scale Second Follow-up [Срок оценки: Before rTMS, four weeks after finishing rTMS.]
- Neuropathic Pain Symptoms Inventory after rTMS [Срок оценки: Before rTMS, up to one day after finishing rTMS.]
- Neuropathic Pain Symptoms Inventory First Follow-up [Срок оценки: Before rTMS, two weeks after finishing rTMS.]
- Neuropathic Pain Symptoms Inventory Second Follow-up [Срок оценки: Before rTMS, four weeks after finishing rTMS.]
- Athens Insomnia Scale after rTMS [Срок оценки: Before rTMS, up to one day after finishing rTMS.]
- Athens Insomnia Scale First Follow-up [Срок оценки: Before rTMS, two weeks after finishing rTMS.]
- Athens Insomnia Scale Second Follow-up [Срок оценки: Before rTMS, four weeks after finishing rTMS.]
- Bilateral Dynamometric Assessment of the strength of the foot extension after rTMS [Срок оценки: Before rTMS, up to one day after finishing rTMS.]
- Bilateral Dynamometric Assessment of the strength of the foot extension First Follow-up [Срок оценки: Before rTMS, two weeks after finishing rTMS.]
- Bilateral Dynamometric Assessment of the strength of the foot extension Second Follow-up [Срок оценки: Before rTMS, four weeks after finishing rTMS.]
Критерии участия
Критерии включения
- Diagnosis of peripheral neuropathy
- Neuropathic pain of constant severity since not less than a month and requiring use of analgesics more than once a week
- Score of 30 millimeter or more on the 100 millimeter visual analog scale of pain intensity at inclusion
Критерии исключения
- Severe depression
- Personality disorders and other psychiatric conditions, which could disturb the participation in the study
- Cognitive deficits, which could disturb the participation in the study
- Epilepsy
- Presence of magnetic material in the reach of magnetic field
- Pregnancy
- Likelihood to get pregnant
- Intracranial electrodes
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
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
Польша · 1 центр
- Jagiellonian University Medical College — Krakow
Идентификаторы
NCT: NCT05295498 · JagiellonianU69