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Not yet recruiting NCT06704789

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

— Observational EEG FNIRS Stroke Normal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Measurement of brain activity (fNIRS, EEG).
Who it may be relevant to
Registry conditions: EEG, FNIRS, Stroke, Normal. Basic parameters: 19 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Measurement of brain activity (fNIRS, EEG)
    Brain activity assessments are conducted as a single session lasting approximately 60 minutes

Primary outcome measures

  • Electroencephalography (EEG) signals [Time frame: Brain activity assessments are conducted as a single session lasting approximately 60 minutes.]
Secondary outcome measures (1)
  • Functional Near-Infrared Spectroscopy(fNIRS) signals [Time frame: Brain activity assessments are conducted as a single session lasting approximately 60 minutes.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-crossover

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06704789 · 11-2024-059

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗