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

27 juli 2026 uppdaterad av: Seyoung Shin

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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

300

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Sydkorea
    • Gyeonggi-do
      • Gyeonggi-do, Gyeonggi-do, Sydkorea, 13497
        • Rekrytering
        • Bundang CHA Medical Center
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Participants will be recruited from the Department of Rehabilitation Medicine at CHA Bundang Medical Center, Republic of Korea.

Beskrivning

Inclusion Criteria:

  1. 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.

  2. 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:

  1. 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.

  2. 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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mini Mental Status Examination
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Seyoung Shin

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

24 juli 2026

Primärt slutförande (Beräknad)

31 december 2030

Avslutad studie (Beräknad)

31 december 2030

Studieregistreringsdatum

Först inskickad

15 juni 2026

Först inskickad som uppfyllde QC-kriterierna

17 juni 2026

Första postat (Faktisk)

22 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2026-04-084

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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