Clinical trial NCT06704789: Investigation of the Possibility of Determining Cerebrovascular Disease Based on Hemodynamic Information of Localized Brain Regions
Official title: Investigation of the Possibility of Determining Cerebrovascular Disease Based on Hemodynamic Information of Localized Brain Regions
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: EEG
FNIRS
Stroke
Normal
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemorrhagic stroke patients, ischemic stroke patients, and healthy adults

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.


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.

Primary outcomes:
measure: Electroencephalography (EEG) signals
timeFrame: Brain activity assessments are conducted as a single session lasting approximately 60 minutes.
Secondary outcomes:
measure: Functional Near-Infrared Spectroscopy(fNIRS) signals
timeFrame: Brain activity assessments are conducted as a single session lasting approximately 60 minutes.
Other outcomes:
Locations:
Study officials:
References: