Идёт набор NCT07293780

Effect of TMS on Neuropathic Pain for Patients With Sci

Без фазы С лечением Spinal Cord Injury 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: active TMS, sham TMS.
Кому может быть актуально: Состояния в реестре: Spinal Cord Injury, Neuropathic Pain. Базовые параметры: 18 лет — 65 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: Turkey (Türkiye)
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

The Effect of Transcranial Magnetic Stimulation Applied to the Primary Motor Cortex and Anterior Cingulate Cortex on Refractory Neuropathic Pain in Spinal Cord Injury

Обзор

The aim of this study is to evaluate the efficacy of rTMS targeting the anterior cingulate cortex, another stimulation site that may be effective in the treatment of neuropathic pain, and to compare it with motor cortex stimulation.

Вмешательства

Устройство active TMS
Patients in the active or sham primary motor cortex rTMS group will receive active or sham rTMS at 5 Hz targeting the M1 area of the lower extremity motor area under medical supervision for a total of 10 sessions over 2 weeks. Patients in the active anterior cingulate cortex rTMS group will also receive active 5 Hz rTMS targeting the anterior cingulate cortex for a total of 10 sessions over 2 weeks under medical supervision.
Устройство sham TMS
Patients in the active or sham primary motor cortex rTMS group will receive active or sham rTMS at 5 Hz targeting the M1 area of the lower extremity motor area under medical supervision for a total of 10 sessions over 2 weeks. Patients in the active anterior cingulate cortex rTMS group will also receive active 5 Hz rTMS targeting the anterior cingulate cortex for a total of 10 sessions over 2 weeks under medical supervision.

Первичные конечные точки

visual analog scale [Срок оценки: first day of treatment, at the end of treatment (at 2nd week), 4 week after end of treatment, 12 week after end of treatment]

Вторичные конечные точки (3)

neuropathic pain scale [Срок оценки: first day of treatment, at the end of treatment (at 2nd week), 4 week after end of treatment, 12 week after end of treatment]
Beck Depression Scale [Срок оценки: first day of treatment, at the end of treatment (at 2nd week), 4 week after end of treatment, 12 week after end of treatment]
5-point Likert scale [Срок оценки: first day of treatment, at the end of treatment (at 2nd week), 4 week after end of treatment, 12 week after end of treatment]

Критерии участия

Критерии включения

Patients for whom at least 12 months have passed since the date of the event
Patients who meet the International Pain Working Group's criteria for central neuropathic pain below the level of the lesion and who have had pain for at least 6 months
Patients aged 18-65
Pain not attributable to other causes such as rheumatological diseases or diabetes
Patients with VAS > 4 despite maximum dose of pharmacological agents (anticonvulsants, antidepressants, narcotics), exercise and physical therapy agents, taking into account renal function tests and other comorbidities