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

17 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Ictus

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

300

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Nome: Seyoung Shin, MD
Numero di telefono: +82437505000
Email: seyoung0706@chamc.co.kr

Luoghi di studio

Corea del Sud
- Gyeonggi-do
  - Gyeonggi-do, Gyeonggi-do, Corea del Sud, 13497
    - Bundang CHA Medical Center
    - Contatto:
      
      Seyoung Shin, MD
      
      Numero di telefono: +82427305000
      
      Email: seyoung0706@chamc.ac.kr

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Adulto
Adulto più anziano

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte Gruppo / Coorte Un gruppo o sottogruppo di partecipanti a uno studio osservazionale che viene valutato per gli esiti biomedici o sanitari.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Mini Mental Status Examination Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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) Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Seyoung Shin

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

31 dicembre 2030

Completamento dello studio (Stimato)

31 dicembre 2030

Date di iscrizione allo studio

Primo inviato

15 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 giugno 2026

Primo Inserito (Effettivo)

22 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

2026-04-084

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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