EEGNCT06704789
Investigation of the Possibility of Determining Cerebrovascular Disease Based on Hemodynamic Information of Localized Brain Regions
An observational study of EEG and FNIRS, run by Pusan National University Yangsan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- What is being tested?
- Measurement of brain activity (fNIRS, EEG)
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hemorrhagic stroke patients, ischemic stroke patients, and healthy adults
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- Measurement of brain activity (fNIRS, EEG)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of brain activity (fNIRS, EEG)Device
Brain activity assessments are conducted as a single session lasting approximately 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| Hemorrhage stroke patients | Not described Receives: Device: Measurement of brain activity (fNIRS, EEG) | |
| Ischemic stroke patients | Not described Receives: Device: Measurement of brain activity (fNIRS, EEG) | |
| Healthy adults | Not described Receives: Device: Measurement of brain activity (fNIRS, EEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Brain activity assessments are conducted as a single session lasting approximately 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EEGStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong-il Shin, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704789
- Sponsor's protocol ID
- 11-2024-059
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Possibility of Determining Cerebrovascular Disease Based on Hemodynamic Information of Localized Brain Regions
- ClinicalTrials.gov ID
- NCT06704789
- Acronym / sponsor ID
- 11-2024-059
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hemorrhagic stroke patients, ischemic stroke patients, and healthy adults
Key inclusion criteria (27 listed)
- For Hemorrhagic Stroke Patients :
- For Ischemic Stroke Patients :
- For Healthy Adults :
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of brain activity (fNIRS, EEG)Brain activity assessments are conducted as a single session lasting approximately 60 minutes | Device | Healthy adults, Hemorrhage stroke patients, Ischemic stroke patients |
Primary outcome
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.
1 secondary outcome
Functional Near-Infrared Spectroscopy(fNIRS) signals
Time frame: Brain activity assessments are conducted as a single session lasting approximately 60 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of EEG and FNIRS, run by Pusan National University Yangsan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youjin Jeong (082-055-360-4159, ctccrc@pnuyh.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalography (EEG) signals (time frame: Brain activity assessments are conducted as a single session lasting approximately 60 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.