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Not yet recruitingNCT06704789Updated Nov 26, 2024

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

An observational study in EEG, FNIRS and Stroke, sponsored by Pusan National University Yangsan Hospital. Not yet recruiting. Open to participants aged 19 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-26.

Sponsored by Pusan National University Yangsan Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
90
Ages
19 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • EEG
  • FNIRS
  • Stroke
  • Normal
03

In context

Cerebrovascular Disorders

374 studies on the registry are indexed under Cerebrovascular Disorders; 129 are open to participants now.

This study's planned enrollment of 90 is below the median of 443 across 135 observational studies indexed under Cerebrovascular Disorders.

Browse Cerebrovascular Disorders studies →

Lead sponsor

Pusan National University Yangsan Hospital is the lead sponsor of 106 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Hemorrhagic stroke patients, ischemic stroke patients, and healthy adults

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

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.
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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)

Interventions

  • DeviceMeasurement of brain activity (fNIRS, EEG)

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

06

What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. 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.

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06704789
Lead sponsor
Pusan National University Yangsan Hospital
Responsible party
Yong-il Shin (Professor, Pusan National University Yangsan Hospital) — Principal investigator
First posted
Nov 26, 2024
Start date
Dec 1, 2024 (estimated)
Primary completion
Dec 1, 2024 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Nov 26, 2024

Study contacts

Youjin Jeong
Contact
ctccrc@pnuyh.co.kr
082-055-360-4159

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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