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NCT Number: NCT06704789

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Measurement of brain activity (fNIRS, EEG)

Device

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

Primary outcomes

  1. Electroencephalography (EEG) signals

    Time frame: Brain activity assessments are conducted as a single session lasting approximately 60 minutes.

    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.

Secondary outcomes

  1. Functional Near-Infrared Spectroscopy(fNIRS) signals

    Time frame: Brain activity assessments are conducted as a single session lasting approximately 60 minutes.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Youjin Jeong

CONTACT

[email protected]

082-055-360-4159

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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