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Набор по приглашению NCT06471309

Effect of Theta Burst Transcranial Magnetic Stimulation on Patients with Dysphagia After Stroke

Без фазы С лечением Stroke Dysphagia Functional Near- Infrared Spectroscopy Transcranial Magnetic Stimulation

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: Theta burst transcranial magnetic stimulation.
Кому может быть актуально
Состояния в реестре: Stroke, Dysphagia, Functional Near- Infrared Spectroscopy, Transcranial Magnetic Stimulation. 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
Китай
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

Effect of Theta Burst Transcranial Magnetic Stimulation on Post-Stroke Dysphagia

Обзор

The purpose of this study was to observe the effect of Theta burst transcranial magnetic stimulation (TBS) on swallowing function in patients with dysphagia after stroke (PSD). Functional near- infrared spectroscopy (fNIRS) was used to detect the changes in activation and functional connectivity of related brain regions in PSD patients treated with intermittent TBS（iTBS）stimulation on the affected side and consistent TBS（cTBS） stimulation on the healthy side. To investigate the effects of TBS on swallowing related cortical excitability in stroke patients with dysphagia and explore its possible mechanism, and provide theoretical basis for the treatment of PSD patients.

Вмешательства

  • Устройство Theta burst transcranial magnetic stimulation
    The stimulation intensity of TBS was 80%RMT, with a total of 600 pulses, five times a week for two weeks. In the bilateral stimulation group, iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side. In the unilateral stimulation group, iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and sham cTBS treatment was given to t

Первичные конечные точки

  • Rosenbek Penetration-aspiration scale [Срок оценки: The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.]
  • Standardized Swallowing Assessment [Срок оценки: The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.]
  • functional near- infrared spectroscopy [Срок оценки: The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.]

Критерии участия

Критерии включения

  • Age 18-80 years old
  • The first stroke lasted from 2 weeks to 6 months, with stable vital signs and right-handedness
  • The stroke met the diagnostic criteria of "Chinese Guidelines for the Diagnosis and Treatment of Cerebral Hemorrhage 2019" or "Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018" formulated by the Cerebrovascular Department of the Branch of Neurology of the Chinese Medical Association, and the cerebral CT or MRI examination showed unilateral cerebral infarction or cerebral hemorrhage.
  • The dysphagia was consistent with the Expert Consensus on the Evaluation and Treatment of dysphagia in China (2017 edition), and the dysphagia was confirmed by videofluoroscopic swallowing study.
  • MMSE>24, good cognitive function
  • The skull is intact without craniotomy or repair
  • Subject or family members sign informed consent

Критерии исключения

  • Combined with other diseases that may cause swallowing disorders, such as Parkinson's disease, dementia, motor neurone disease and other neurological diseases, or esophageal, neck surgery and other diseases that cause swallowing organ structure abnormalities
  • A history of mental illness or epilepsy
  • A metal implant in the head or eye, a pacemaker or a drug pump in the body
  • Pregnancy, malignant tumor, serious disease history of heart, liver, kidney and other important organs
  • Ulceration or infection of the skin on the head or where the electrode is applied
  • Poor compliance and inability to complete basic treatment

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

Китай · 1 центр
  • The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу

Идентификаторы

NCT: NCT06471309 · 20240619

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗