Investigation of the Possibility of Determining Cerebrovascular Disease Based on Hemodynamic Information of Localized Brain Regions

NCT ID: NCT06704789

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-12-31

Brief Summary

The purpose of this study is to compare hemodynamic information from localized brain regions between stroke patients and healthy adults using brain activity data (fNIRS and EEG) and to assess the accuracy of early stroke diagnosis and classification predictions.

Conditions

EEG; FNIRS; Stroke; Normal

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

Hemorrhage stroke patients

Measurement of brain activity (fNIRS, EEG)

Intervention Type: DEVICE

Brain activity assessments are conducted as a single session lasting approximately 60 minutes

Ischemic stroke patients

Measurement of brain activity (fNIRS, EEG)

Intervention Type: DEVICE

Brain activity assessments are conducted as a single session lasting approximately 60 minutes

Healthy adults

Measurement of brain activity (fNIRS, EEG)

Intervention Type: DEVICE

Brain activity assessments are conducted as a single session lasting approximately 60 minutes

Interventions

Measurement of brain activity (fNIRS, EEG)

Brain activity assessments are conducted as a single session lasting approximately 60 minutes

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. For Hemorrhagic Stroke Patients :

• Adults aged between 19 and 80 years.
• Diagnosed with hemorrhagic stroke through clinical observation and neuroimaging.
• First-time hemorrhagic stroke patients.
• Hemorrhagic stroke onset between 2 weeks and 12 months prior to screening.
• Hemorrhagic lesion located in the cortex or subcortex.
• Not taking medications that could affect brain hemodynamics, such as - antihypertensives, anticoagulants, antiplatelets, or antidepressants.
• Able to read and understand the informed consent form and participate in questionnaires with sufficient language proficiency.
• Voluntarily agree to participate in the study and provide written consent, with the ability to complete the study duration.

2. For Ischemic Stroke Patients :

• Adults aged between 19 and 80 years.
• Diagnosed with ischemic stroke through clinical observation and neuroimaging.
• First-time ischemic stroke patients.
• Ischemic stroke onset between 2 weeks and 12 months prior to screening.
• Ischemic lesion located in the cortex or subcortex.
• Not taking medications that could affect brain hemodynamics, such as antihypertensives, anticoagulants, antiplatelets, or antidepressants.
• Able to read and understand the informed consent form and participate in questionnaires with sufficient language proficiency.
• Voluntarily agree to participate in the study and provide written consent, with the ability to complete the study duration.

3. For Healthy Adults :

• Adults aged between 19 and 80 years.
• No history of stroke or transient ischemic attack (TIA).
• No stroke risk factors such as hypertension, diabetes, or hyperlipidemia.
• No chronic diseases (e.g., cardiovascular disease, chronic kidney disease, chronic lung disease).
• No psychiatric conditions (e.g., depression, schizophrenia).
• Not taking medications that could affect brain hemodynamics, such as antihypertensives, anticoagulants, antiplatelets, or antidepressants.
• Able to read and understand the informed consent form and participate in questionnaires with sufficient language proficiency.
• Voluntarily agree to participate in the study and provide written consent, with the ability to complete the study duration.

Exclusion Criteria

• History of head trauma in the past 6 months.
• Ongoing severe chronic diseases (e.g., heart failure, chronic kidney disease, chronic lung disease).
• Severe psychiatric disorders such as schizophrenia, major depression, or bipolar disorder.
• Use of medications that could influence brain hemodynamics (e.g., antihypertensives, anticoagulants, antiplatelets, or antidepressants).
• Participation in a study and use of experimental drugs within the past 30 days.
• Pregnant or breastfeeding women.
• Major surgery in the past 6 months.
• Acute infections or inflammatory diseases.
• Cognitive impairment or dementia.
• Neurological disorders.
• Inability to understand the study procedures or unwillingness to provide voluntary consent.
• Any other clinical concerns deemed inappropriate for participation by the principal investigator or study team.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yong-il Shin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Youjin Jeong

Role: CONTACT

ctccrc@pnuyh.co.kr

082-055-360-4159

Other Identifiers

11-2024-059

Identifier Type: -

Identifier Source: org_study_id