Investigation of the Possibility of Determining Cerebrova... | NCT06704789

Status Module

Label	Type	Description	Intervention Names
Hemorrhage stroke patients			Device: Measurement of brain activity (fNIRS, EEG)
Ischemic stroke patients			Device: Measurement of brain activity (fNIRS, EEG)
Healthy adults			Device: Measurement of brain activity (fNIRS, EEG)

Name	Type	Description	Arm Group Labels	Other Names
Measurement of brain activity (fNIRS, EEG)	Device	Brain activity assessments are conducted as a single session lasting approximately 60 minutes	Healthy adults Hemorrhage stroke patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Electroencephalography (EEG) signals	Brainwaves are electrical currents generated when signals are transmitted between neurons in the nervous system. They vary depending on the mental and physical state of an individual and serve as one of the most critical indicators for measuring brain activity. Brainwaves can be recorded using devices such as electroencephalography (EEG), and in some cases, electrodes may be attached directly to the cortex. These devices are used to evaluate conditions such as brain damage, epilepsy, or other neurological disorders, as well as to legally determine brain death.	Brain activity assessments are conducted as a single session lasting approximately 60 minutes.

Secondary Outcomes

Measure	Description	Time Frame
Functional Near-Infrared Spectroscopy(fNIRS) signals	The near-infrared spectrum between 800 nm and 2500 nm is commonly used to measure changes in reflectance, absorbance, and scattering coefficients associated with specific processes involving molecules or ions. This allows for the assessment of parameters such as oxygen saturation, blood flow, glucose levels, and energy metabolism in the bloodstream by analyzing changes in the distribution of oxyhemoglobin and deoxyhemoglobin in areas like the fingers, wrists, and brain blood flow. In this study, it is specifically utilized to measure oxygen saturation in brain blood flow.

Eligibility Module

Eligibility Criteria

Inclusion Criteria :

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.
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.
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.

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D003943	Diagnostic Techniques, Neurological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004568	Electrodiagnosis