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NCT Number: NCT07660263

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mini Mental Status Examination

    Time frame: 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.

  2. Korean Montreal Cognitive Assessment

    Time frame: 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.

  3. Clinical Dementia Rating

    Time frame: 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.

  4. Functional Ambulation Category

    Time frame: 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.

  5. Modified Barthel Index

    Time frame: 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.

  6. Berg Balance Scale

    Time frame: 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.

  7. Electroencephalography Delta-Alpha Ratio

    Time frame: 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.

  8. Electroencephalography Functional Connectivity Index

    Time frame: Baseline to 36 months

    Functional connectivity indices derived from electroencephalography recordings to assess connectivity between brain regions and overall brain network organization.

  9. Functional Near-Infrared Spectroscopy (fNIRS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Seyoung Shin, MD

CONTACT

[email protected]

+82437505000

Sponsors and collaborators

Lead sponsor

Seyoung Shin

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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