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Идёт набор NCT06832839

Study on the Mechanism of Cognitive Impairment in Patients with Moyamoya Disease

Наблюдательное Moyamoya Disease

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: Revascularization.
Кому может быть актуально
Состояния в реестре: Moyamoya Disease. Базовые параметры: 18 лет — 60 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 →

Обзор

The purpose of this study is to comprehensively evaluate the risk factors for cognitive decline in patients with moyamoya disease, identify imaging target areas associated with cognitive damage in the brain, and explore the changes in brain structure and functional networks resulting from cerebral revascularization, as well as their relationship with cognitive improvement.

Подробное описание

Moyamoya disease (MMD) is a chronic occlusive-stenosis cerebrovascular disease that characterized by the stenosis of internal carotid artery termination and the formation of net-like vessel. It is a multifactorial disease caused by genetic, inflammatory, immunological and other environmental factors. The specific pathogenesis of MMD is still unclear. The treatment modalities of revascularization and conservative management have been used in patients with MMD. Due to the long-term low perfusion state of brain tissue, most patients with MMD experience varying degrees of cognitive dysfunction, although the underlying mechanisms remain unclear. We will employ a combination of 256-lead high-density electroencephalography, multimodal magnetic resonance imaging, and biological samples to conduct a comprehensive evaluation of the risk factors associated with cognitive decline in patients with MMD. Our objectives include identifying target imaging areas indicative of cognitive damage in the brain and exploring the structural and functional changes in the cerebral network resulting from revascularization, as well as their relationship with cognitive improvement.

Вмешательства

  • Процедура Revascularization
    Revascularization

Первичные конечные точки

  • Change in composite score of neurocognitive function at 6 months after treatment. [Срок оценки: 6 months during follow-up]
Вторичные конечные точки (12)
  • Changes in composite score of neurocognitive function at 12 and 24 months after treatment. [Срок оценки: 12 and 24 months during follow-up]
  • Rate of participants experiencing cerebrovascular events (TIA, infarction and hemorrhage) within 6, 12 and 24 months after treatment. [Срок оценки: 6, 12 and 24 months during follow-up]
  • Changes in neurological function assessed by modified Rankin scale (mRS) at 6, 12, and 24 months following treatment. [Срок оценки: 6, 12 and 24 months during follow-up]
  • Changes in neurological function assessed by National Institute of Health stroke scale (NIHSS) at 6, 12, and 24 months following treatment. [Срок оценки: 6, 12 and 24 months during follow-up]
  • Changes in cerebral blood perfusion assessed by arterial spin labeling (ASL) at 6, 12, and 24 months after treatment. [Срок оценки: 6, 12 and 24 months during follow-up]
  • Hemodynamic changes at the terminal segment of internal carotid artery assessed by computational fluid dynamics (CFD) at 6, 12, and 24 months after treatment. [Срок оценки: 6, 12 and 24 months during follow-up]
  • Morphological changes at the terminal segment of internal carotid artery and middle cerebral artery wall assessed by high-resolution vessel wall imaging at 6, 12, and 24 months after treatment. [Срок оценки: 6, 12 and 24 months during follow-up]
  • Changes in Power Spectral Density (PSD) assessed by electroencephalography (EEG) at 6, 12, and 24 months after treatment will be measured. [Срок оценки: 6, 12 and 24 months during follow-up]
  • Changes in Phase Locking Value (PLV) assessed by electroencephalogram (EEG) at 6, 12, and 24 months after treatment will be measured. [Срок оценки: 6, 12 and 24 months during follow-up]
  • Changes in Phase-Lag Index (PLI) assessed by electroencephalogram (EEG) at 6, 12, and 24 months after treatment will be measured. [Срок оценки: 6, 12 and 24 months during follow-up]
  • Changes in Degree Centrality assessed by multimodal MRI at 6, 12, and 24 months after treatment. [Срок оценки: 6, 12 and 24 months during follow-up]
  • Changes in Clustering Coefficient assessed by multimodal MRI at 6, 12, and 24 months after treatment. [Срок оценки: 6, 12 and 24 months during follow-up]

Критерии участия

Критерии включения

  • The admission cerebral angiography (DSA) examination fulfills the diagnostic criteria for moyamoya disease.
  • Please sign the informed consent form.
  • Participants must be between 18 and 60 years of age.

Критерии исключения

  • Patients with concurrent atherosclerosis, autoimmune diseases, meningitis, brain tumors, Down syndrome, craniocerebral trauma, prior radioactive head irradiation, or hyperthyroidism, which may result in secondary cerebrovascular lesions leading to symptoms associated with smoke syndrome.
  • Individuals younger than 18 years or older than 60 years.
  • Those with contraindications for magnetic resonance imaging.
  • Patients who are unable to complete cognitive brain assessments

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Beijing Tiantan Hospital — Пекин

Идентификаторы

NCT: NCT06832839 · KY2024-112-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗