StrokeNCT07660263
Development of a Genomics-based Multimodal Prediction Model for Post-stroke Vascular Dementia
An observational study of Stroke, run by Seyoung Shin at 1 site in South Korea.
Trial summary
To collect large-scale multimodal data, including genomic information, neuroimaging, neurophysiological measures, cognitive assessments, and clinical characteristics from stroke survivors and healthy controls. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jul 2026to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from the Department of Rehabilitation Medicine at CHA Bundang Medical Center, Republic of Korea.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Bundang CHA Medical Center
Gyeonggi-do, Gyeonggi-do, 13497
Seyoung Shin, MD, +82427305000, seyoung0706@chamc.ac.kr
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start24 Jul 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seyoung Shin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seyoung Shin, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660263
- Sponsor's protocol ID
- 2026-04-084
- Status last verified
- Jul 2026
- First submitted
- 15 Jun 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Genomics-based Multimodal Prediction Model for Post-stroke Vascular Dementia: An Ambidirectional Patient-Control Cohort Study
- ClinicalTrials.gov ID
- NCT07660263
- Acronym / sponsor ID
- 2026-04-084
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Seyoung ShinUniversity, hospital or other
- Study start
- 24 Jul 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the Department of Rehabilitation Medicine at CHA Bundang Medical Center, Republic of Korea.
Key inclusion criteria (12 listed)
- Healthy Control Group:
- Stroke Patient Group:
- 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.
Key exclusion criteria (14 listed)
- Healthy Control Group:
- Stroke Patient Group:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Seyoung Shin at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seyoung Shin, MD (+82437505000, seyoung0706@chamc.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Mental Status Examination (time frame: Baseline to 36 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.