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

June 17, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
    • Gyeonggi-do
      • Gyeonggi-do, Gyeonggi-do, South Korea, 13497

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to 36 months
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.
Baseline to 36 months
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.
Baseline to 36 months
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.
Baseline to 36 months
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.
Baseline to 36 months
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.
Baseline to 36 months
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.
Baseline to 36 months
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.
Baseline to 36 months
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.
Baseline to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seyoung Shin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026-04-084

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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