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

NCT06704789 | Not Yet Recruiting

• 1 other identifier: 11-2024-059
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

EEG; FNIRS; Stroke; Normal

Outcome Measures

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.

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

Secondary Outcomes (1)

• Functional Near-Infrared Spectroscopy(fNIRS) signals

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

Study Arms (3)

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

Measurement of brain activity (fNIRS, EEG) DEVICE

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

Healthy adults; Hemorrhage stroke patients; Ischemic stroke patients

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hemorrhagic stroke patients, ischemic stroke patients, and healthy adults

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

MeSH Terms

Conditions

Stroke

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Youjin Jeong

CONTACT

082-055-360-4159; ctccrc@pnuyh.co.kr

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 26, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share