Development of a Genomics-based Multimodal Prediction Model for Post-stroke Vascular Dementia
Development of a Genomics-based Multimodal Prediction Model for Post-stroke Vascular Dementia: An Ambidirectional Patient-Control Cohort Study
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Seyoung Shin, MD
- Número de teléfono: +82437505000
- Correo electrónico: seyoung0706@chamc.co.kr
Ubicaciones de estudio
-
-
Gyeonggi-do
-
Gyeonggi-do, Gyeonggi-do, Corea del Sur, 13497
- Bundang CHA Medical Center
-
Contacto:
- Seyoung Shin, MD
- Número de teléfono: +82427305000
- Correo electrónico: seyoung0706@chamc.ac.kr
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Stroke patients
Adults aged 19 years or older with first-ever ischemic or hemorrhagic stroke.
Participants may be enrolled during the subacute or chronic stage after stroke and will undergo genomic, neuroimaging, neurophysiological, cognitive, and functional assessments with longitudinal follow-up for up to 36 months.
|
|
Healthy controls
Cognitively normal adults aged 19 years or older without a history of stroke, transient ischemic attack, or other major central nervous system disorders.
Participants will undergo genomic, neuroimaging, neurophysiological, cognitive, and functional assessments and follow-up evaluations.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mini Mental Status Examination
Periodo de tiempo: Baseline to 36 months
|
Mini Mental State Examination is a 30-question assessment of cognitive function that evaluates attention and orientation, memory, registration, recall, calculation, language, and ability to draw a complex polygon (range 0-30).
Higher scores indicate better cognitive function.
|
Baseline to 36 months
|
|
Korean Montreal Cognitive Assessment
Periodo de tiempo: Baseline to 36 months
|
The Korean Montreal Cognitive Assessment is a cognitive screening tool designed to detect mild cognitive impairment.
It evaluates multiple cognitive domains including attention, executive function, memory, language, visuospatial ability, abstraction, calculation, and orientation (range 0-30).
Higher scores indicate better cognitive function.
|
Baseline to 36 months
|
|
Clinical Dementia Rating
Periodo de tiempo: Baseline to 36 months
|
The Clinical Dementia Rating is a clinician-rated scale used to assess the severity of cognitive impairment and dementia across six domains including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care (range 0-3).
Higher scores indicate greater cognitive impairment and worse outcomes.
|
Baseline to 36 months
|
|
Functional Ambulation Category
Periodo de tiempo: Baseline to 36 months
|
The Functional Ambulation Categories is a 5-point functional walking test that evaluates ambulation ability, determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device (range 0-5).
Higher scores indicate greater independence in ambulation.
|
Baseline to 36 months
|
|
Modified Barthel Index
Periodo de tiempo: Baseline to 36 months
|
The Modified Barthel Index is a scale used to measure disability or dependence in activities of daily living in stroke survivors (range 0-100).
Higher scores indicate greater independence in activities of daily living.
|
Baseline to 36 months
|
|
Berg Balance Scale
Periodo de tiempo: Baseline to 36 months
|
The Berg Balance Scale is a 14-item performance-based measure used to assess static and dynamic balance abilities and risk of falling in individuals with neurological disorders (range 0-56).
Higher scores indicate better balance performance and lower risk of falling.
|
Baseline to 36 months
|
|
Electroencephalography Delta-Alpha Ratio
Periodo de tiempo: Baseline to 36 months
|
The delta-alpha ratio (DAR) is a quantitative electroencephalographic measure calculated as delta power divided by alpha power.
Higher DAR values indicate greater electroencephalography slowing and are associated with impaired brain function.
|
Baseline to 36 months
|
|
Electroencephalography Functional Connectivity Index
Periodo de tiempo: Baseline to 36 months
|
Functional connectivity indices derived from electroencephalography recordings to assess connectivity between brain regions and overall brain network organization.
|
Baseline to 36 months
|
|
Functional Near-Infrared Spectroscopy (fNIRS)
Periodo de tiempo: Baseline to 36 months
|
Functional near-infrared spectroscopy is a non-invasive neuroimaging technique used to assess cortical activation by measuring changes in oxygenated and deoxygenated hemoglobin during task performance.
|
Baseline to 36 months
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-04-084
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .