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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; EEG; Normal; FNIRS
• Intervention / Treatment: Device: Measurement of brain activity (fNIRS, EEG)

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Youjin Jeong; Phone Number: 082-055-360-4159; Email: ctccrc@pnuyh.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Hemorrhagic stroke patients, ischemic stroke patients, and healthy adults

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy adults	Device: Measurement of brain activity (fNIRS, EEG); Brain activity assessments are conducted as a single session lasting approximately 60 minutes
Ischemic stroke patients	Device: Measurement of brain activity (fNIRS, EEG); Brain activity assessments are conducted as a single session lasting approximately 60 minutes
Hemorrhage stroke patients	Device: Measurement of brain activity (fNIRS, EEG); Brain activity assessments are conducted as a single session lasting approximately 60 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Estimated): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders
• Other Study ID Numbers: 11-2024-059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No