Development of a Genomics-based Multimodal Prediction Model for Post-stroke Vascular Dementia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development of a Genomics-based Multimodal Prediction Model for Post-stroke Vascular Dementia: An Ambidirectional Patient-Control Cohort Study
Overview
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.
Detailed description
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.
Primary outcome measures
- Mini Mental Status Examination [Time frame: Baseline to 36 months]
- Korean Montreal Cognitive Assessment [Time frame: Baseline to 36 months]
- Clinical Dementia Rating [Time frame: Baseline to 36 months]
- Functional Ambulation Category [Time frame: Baseline to 36 months]
- Modified Barthel Index [Time frame: Baseline to 36 months]
- Berg Balance Scale [Time frame: Baseline to 36 months]
- Electroencephalography Delta-Alpha Ratio [Time frame: Baseline to 36 months]
- Electroencephalography Functional Connectivity Index [Time frame: Baseline to 36 months]
- Functional Near-Infrared Spectroscopy (fNIRS) [Time frame: Baseline to 36 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Bundang CHA Medical Center — Gyeonggi-do
Identifiers
NCT: NCT07660263 · 2026-04-084