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Набор скоро начнётся NCT07496645

EFFECT OF ANODAL TRANSCRANIAL DIRECT CURRENT STIMULATION ON NAMING IN APHASIC PATIENTS WITH ACUTE ISCHEMIC STROKE

Фаза III С лечением Acute Ischemic Cerebrovascular Disease Post Stroke Aphasia Aphasia Following Cerebral Infarction Aphasia, Acquired

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: Transcranial Direct Current Stimulation, Transcranial Direct Current Stimulation.
Кому может быть актуально
Состояния в реестре: Acute Ischemic Cerebrovascular Disease, Post Stroke Aphasia, Aphasia Following Cerebral Infarction, Aphasia, Acquired. 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
Индия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The use of transcranial direct current stimulation (tDCS) for the management of deficits developed in stroke is a relatively new type of management option. Many of the studies performed using tDCS have focused on improvements noted in hemiplegia as compared to aphasia, which is an equally disabling outcome of strokes. The results of these studies have not been conclusive and concordant with each other. In aphasia management, the majority of the studies have focused on chronic strokes. Since the use of tDCS is relatively new, the studies have not focused on a particular type of deficit or stroke. Very few studies have focused on the impact of solely using tDCS. Very few studies have focused on acute to subacute strokes. The results of the studies have, nevertheless, been encouraging. Improvements in aspects of language tested after a single session of tDCS are short-lived. There is an unmet need to probe the utility of repetitive tDCS on aspects of language function in patients who are aphasic due to acute stroke. There is also a paucity of data in the Indian scenario regarding the same.

Вмешательства

  • Устройство Transcranial Direct Current Stimulation
    Anodal tDCS
  • Устройство Transcranial Direct Current Stimulation
    Sham tDCS

Первичные конечные точки

  • Primary Outcome: Difference of change in Accuracy between Anodal tDCS group and Sham tDCS group at 5 days [Срок оценки: at 5 days after tDCS]
  • Co-Primary outcome: Difference of change in Reaction Time between Anodal tDCS group and Sham tDCS group at 5 days [Срок оценки: at 5 days after tDCS]
Вторичные конечные точки (6)
  • Difference of change in Correct Response between Anodal tDCS group and Sham tDCS group at 5 days [Срок оценки: at 5 days after tDCS]
  • Difference of change in PNT Score between Anodal tDCS group and Sham tDCS group at 5 days [Срок оценки: at 5 days after tDCS]
  • Difference of change in Accuracy between Anodal tDCS group and Sham tDCS group at 4 weeks [Срок оценки: at 4 weeks after tDCS]
  • Difference of change in Reaction Time between Anodal tDCS group and Sham tDCS group at 4 weeks [Срок оценки: at 4 weeks after tDCS]
  • Difference of change in Correct Response between Anodal tDCS group and Sham tDCS group at 4 weeks [Срок оценки: at 4 weeks after tDCS]
  • Difference of change in PNT Score between Anodal tDCS group and Sham tDCS group at 4 weeks [Срок оценки: at 4 weeks after tDCS]

Критерии участия

Критерии включения

  • Aphasic patients with left middle cerebral artery territory Acute Ischemic Stroke
  • Patients between 18-65 years of age.
  • Within 5 days of onset of stroke.

Критерии исключения

  • Patients with malignant Middle Cerebral Artery territory infarcts and previous clinical history of cerebral hemisphere stroke.
  • Patients with history of previous brain surgery or skull defect due to surgery e.g. craniectomy.
  • Patients with epilepsy.
  • Patients with history of significant head trauma in the last 1 month.
  • Patients with documented history of major depression prior to stroke.
  • Patients with alcohol/drug abuse in the past 6 months.
  • Patients with prior significant cognitive impairment.
  • Pacemaker in situ, cochlear implant in situ.
  • Pregnancy.

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
Четверное слепое
Основная цель
Организация здравоохранения

Центры проведения

Индия · 1 центр
  • Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital, New — New Delhi

Идентификаторы

NCT: NCT07496645 · IEC/ABVIMS/RMLH/1093

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗