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

NCT07660263 | Recruiting

• 1 other identifier: 2026-04-084
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (9)

• Mini Mental Status Examination

  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

  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

  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

  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

  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

  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

  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

  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)

  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

Study Arms (2)

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seyoung Shin: lead

Study Sites (1)

Bundang CHA Medical Center

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

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Seyoung Shin, MD

CONTACT

+82437505000; seyoung0706@chamc.co.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start: July 24, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

KR (1)