Development of a Genomics-based Multimodal Prediction Model for Post-stroke Vascular Dementia

Официальное название

Development of a Genomics-based Multimodal Prediction Model for Post-stroke Vascular Dementia: An Ambidirectional Patient-Control Cohort Study

Обзор

To collect large-scale multimodal data, including genomic information, neuroimaging, neurophysiological measures, cognitive assessments, and clinical characteristics from stroke survivors and healthy controls. This study aims to develop and validate an integrated prediction model for identifying individuals at high risk of post-stroke vascular dementia and to establish a foundation for precision medicine approaches in stroke-related cognitive impairment.

Подробное описание

This study aims to establish a comprehensive multimodal dataset integrating genomic information, clinical characteristics, neuroimaging, neurophysiological measures, and longitudinal cognitive assessments in stroke survivors and cognitively healthy controls. The study includes participants from the subacute to chronic stages after stroke and follows them longitudinally to capture changes in cognitive and functional outcomes over time.

By combining whole genome sequencing, magnetic resonance imaging (MRI), electroencephalography (EEG), functional near-infrared spectroscopy (fNIRS), and clinical assessments, the study seeks to characterize factors associated with cognitive decline and vascular dementia following stroke.

The collected data will be used to develop and validate an integrated multimodal prediction model capable of identifying individuals at elevated risk of post-stroke vascular dementia. The findings are expected to improve risk stratification, support individualized monitoring and intervention strategies, and contribute to the development of precision medicine approaches for stroke survivors.

Первичные конечные точки

• Mini Mental Status Examination [Срок оценки: Baseline to 36 months]
• Korean Montreal Cognitive Assessment [Срок оценки: Baseline to 36 months]
• Clinical Dementia Rating [Срок оценки: Baseline to 36 months]
• Functional Ambulation Category [Срок оценки: Baseline to 36 months]
• Modified Barthel Index [Срок оценки: Baseline to 36 months]
• Berg Balance Scale [Срок оценки: Baseline to 36 months]
• Electroencephalography Delta-Alpha Ratio [Срок оценки: Baseline to 36 months]
• Electroencephalography Functional Connectivity Index [Срок оценки: Baseline to 36 months]
• Functional Near-Infrared Spectroscopy (fNIRS) [Срок оценки: Baseline to 36 months]

Критерии участия

Критерии включения

• Healthy Control Group:

• Adults aged 19 years or older.
• Able to be age- and sex-matched to the stroke cohort.
• No history of stroke, transient ischemic attack (TIA), or other central nervous system disorders.
• Cognitive function within the normal range for age and education level based on screening assessments (K-MMSE and K-MoCA).
• Able to understand the study procedures and provide written informed consent.
• Stroke Patient Group:

• Adults aged 19 years or older.
• First-ever ischemic or hemorrhagic stroke confirmed by CT or MRI.
• Enrolled in one of the following strata according to time since stroke onset:

Stratum A: 7 days to 3 months after stroke onset. Stratum B: >3 months to 12 months after stroke onset. Stratum C: >12 months to 36 months after stroke onset.

\- Able to understand the study procedures and provide written informed consent, or consent provided by a legally authorized representative when applicable.

Критерии исключения

• Healthy Control Group:

• Current severe psychiatric disorders that may affect cognitive function (e.g., major depression, schizophrenia) or use of related medications.
• Strong family history of hereditary cerebrovascular disorders (e.g., CADASIL).
• Severe medical illness considered inappropriate for study participation.
• Any condition that, in the opinion of the investigator, would make participation unsuitable.
• Stroke Patient Group:

• Impaired ability to provide consent (MMSE <10) without an accompanying caregiver or legally authorized representative.
• History of dementia due to causes other than stroke (e.g., Alzheimer's disease) prior to stroke onset.
• History of major neurological disorders affecting cognition prior to stroke onset (e.g., Parkinson's disease, brain tumor, multiple sclerosis).
• Severe aphasia or impaired consciousness preventing completion of cognitive assessments.
• Current or pre-stroke severe psychiatric disorders that may affect cognitive function (e.g., major depression, schizophrenia) or use of related medications.
• Strong family history of hereditary cerebrovascular disorders (e.g., CADASIL).
• Contraindication to MRI (e.g., metallic implants) or refusal to provide blood samples for genomic analysis.
• Any condition that, in the opinion of the investigator, would make participation unsuitable.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 1 центр

• Bundang CHA Medical Center — Gyeonggi-do

Идентификаторы

NCT: NCT07660263 · 2026-04-084

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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