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

Pusan National University Yangsan Hospital

Status: Not yet enrolling

Conditions: EEG; Stroke; FNIRS; Normal

Treatments: Device: Measurement of brain activity (fNIRS, EEG)

Study type: Observational

Funder types: Other

Identifiers

NCT06704789

11-2024-059

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

90 participants in 3 patient groups

Hemorrhage stroke patients

Treatment:

Device: Measurement of brain activity (fNIRS, EEG)

Ischemic stroke patients

Treatment:

Device: Measurement of brain activity (fNIRS, EEG)

Healthy adults

Treatment:

Device: Measurement of brain activity (fNIRS, EEG)