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Набор скоро начнётся NCT06704789

Investigation of the Possibility of Determining Cerebrovascular Disease Based on Hemodynamic Information of Localized Brain Regions

— Наблюдательное EEG FNIRS Stroke Normal

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: Measurement of brain activity (fNIRS, EEG).
Кому может быть актуально
Состояния в реестре: EEG, FNIRS, Stroke, Normal. Базовые параметры: 19 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
Список центров уточняется — проверьте первичный протокол.
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 purpose of this study is to compare hemodynamic information from localized brain regions between stroke patients and healthy adults using brain activity data (fNIRS and EEG) and to assess the accuracy of early stroke diagnosis and classification predictions.

Вмешательства

  • Устройство Measurement of brain activity (fNIRS, EEG)
    Brain activity assessments are conducted as a single session lasting approximately 60 minutes

Первичные конечные точки

  • Electroencephalography (EEG) signals [Срок оценки: Brain activity assessments are conducted as a single session lasting approximately 60 minutes.]
Вторичные конечные точки (1)
  • Functional Near-Infrared Spectroscopy(fNIRS) signals [Срок оценки: Brain activity assessments are conducted as a single session lasting approximately 60 minutes.]

Критерии участия

Критерии включения

  • For Hemorrhagic Stroke Patients :
  • Adults aged between 19 and 80 years.
  • Diagnosed with hemorrhagic stroke through clinical observation and neuroimaging.
  • First-time hemorrhagic stroke patients.
  • Hemorrhagic stroke onset between 2 weeks and 12 months prior to screening.
  • Hemorrhagic lesion located in the cortex or subcortex.
  • Not taking medications that could affect brain hemodynamics, such as - antihypertensives, anticoagulants, antiplatelets, or antidepressants.
  • Able to read and understand the informed consent form and participate in questionnaires with sufficient language proficiency.
  • Voluntarily agree to participate in the study and provide written consent, with the ability to complete the study duration.
  • For Ischemic Stroke Patients :
  • Adults aged between 19 and 80 years.
  • Diagnosed with ischemic stroke through clinical observation and neuroimaging.
  • First-time ischemic stroke patients.
  • Ischemic stroke onset between 2 weeks and 12 months prior to screening.
  • Ischemic lesion located in the cortex or subcortex.
  • Not taking medications that could affect brain hemodynamics, such as antihypertensives, anticoagulants, antiplatelets, or antidepressants.
  • Able to read and understand the informed consent form and participate in questionnaires with sufficient language proficiency.
  • Voluntarily agree to participate in the study and provide written consent, with the ability to complete the study duration.
  • For Healthy Adults :
  • Adults aged between 19 and 80 years.
  • No history of stroke or transient ischemic attack (TIA).
  • No stroke risk factors such as hypertension, diabetes, or hyperlipidemia.
  • No chronic diseases (e.g., cardiovascular disease, chronic kidney disease, chronic lung disease).
  • No psychiatric conditions (e.g., depression, schizophrenia).
  • Not taking medications that could affect brain hemodynamics, such as antihypertensives, anticoagulants, antiplatelets, or antidepressants.
  • Able to read and understand the informed consent form and participate in questionnaires with sufficient language proficiency.
  • Voluntarily agree to participate in the study and provide written consent, with the ability to complete the study duration.

Критерии исключения

  • History of head trauma in the past 6 months.
  • Ongoing severe chronic diseases (e.g., heart failure, chronic kidney disease, chronic lung disease).
  • Severe psychiatric disorders such as schizophrenia, major depression, or bipolar disorder.
  • Use of medications that could influence brain hemodynamics (e.g., antihypertensives, anticoagulants, antiplatelets, or antidepressants).
  • Participation in a study and use of experimental drugs within the past 30 days.
  • Pregnant or breastfeeding women.
  • Major surgery in the past 6 months.
  • Acute infections or inflammatory diseases.
  • Cognitive impairment or dementia.
  • Neurological disorders.
  • Inability to understand the study procedures or unwillingness to provide voluntary consent.
  • Any other clinical concerns deemed inappropriate for participation by the principal investigator or study team.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-кроссовер

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06704789 · 11-2024-059

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗