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Active, not recruiting Observational

Prefrontal Brain Activity and ECG Patterns in Stroke and Healthy Adults

NCT07322107 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2025-11-06
Last updated
2026-01-07

Condition(s) studied

StrokeHealthy Participants

Study summary

This observational study will evaluate brain activity and heart rhythm patterns in people with and without stroke. Brain activity will be measured using functional near-infrared spectroscopy (fNIRS) and electroencephalography (EEG), and cardiac activity will be measured using electrocardiography (ECG). The goal is to characterize differences in prefrontal brain activation and ECG features between stroke patients and healthy adults

Eligibility

Sex
ALL
Min age
19 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Intracerebral Hemorrhage Group (Stroke Patients) Adults aged 19 to 80 years. Diagnosed with intracerebral hemorrhage based on clinical evaluation and neuroimaging findings. Able to read and understand the participant information sheet and consent form, and capable of completing questionnaires in the study language. Voluntarily agrees to participate in the study, provides written informed consent, and is able to participate for the entire study period. Cerebral Infarction Group (Stroke Patients) Adults aged 19 to 80 years. Diagnosed with cerebral infarction (ischemic stroke) based on clinical evaluation and neuroimaging findings. Able to read and understand the participant information sheet and consent form, and capable of completing questionnaires in the study language. Voluntarily agrees to participate in the study, provides written informed consent, and is able to participate for the entire study period. Healthy Adult Group Adults aged 19 to 80 years. No history of stroke or transient ischemic attack (TIA). No major stroke risk factors such as hypertension, diabetes mellitus, or hyperlipidemia. No chronic diseases, including cardiovascular disease, chronic kidney disease, or chronic pulmonary disease. No psychiatric disorders, such as depression or schizophrenia. Not taking medications that may affect cerebral hemodynamics, including antihypertensive agents, anticoagulants, antiplatelet agents, or antidepressants. Able to read and understand the participant information sheet and consent form, and capable of completing questionnaires in the study language. Voluntarily agrees to participate in the study, provides written informed consent, and is able to participate for the entire study period. Exclusion Criteria: * Participants meeting any of the following exclusion criteria will not be enrolled in the study. History of head trauma or cranial surgery within the past 6 months with wounds that have not yet fully healed. Current diagnosis of a severe psychiatric disorder, such as schizophrenia, major depressive disorder, or bipolar disorder. Participation in another clinical study and intake of an investigational drug within the past 30 days. Women who are pregnant or breastfeeding. Presence of an acute infection or inflammatory disease. Inability to adequately understand the study procedures or lack of voluntary consent to participate. Any other clinically significant finding that, in the judgment of the principal investigator or designated study physician, makes the individual unsuitable for participation in this study.

Primary outcome measure(s)

  • Resting-State Prefrontal EEG Activity — Single assessment at one visit (approximately 30-minute session).
    Quantitative characteristics of resting-state electroencephalographic (EEG) activity recorded from the prefrontal cortex (Fp1, Fp2, F7, F8) using a 10-20 electrode placement system during 10 minutes of eyes-closed rest. EEG is obtained once for each participant in one of three groups (intracerebral hemorrhage, cerebral infarction, healthy adults) within a 30-minute session including approximately 10 minutes of preparation, 10 minutes of recording, and 10 minutes of completion procedures.
  • Resting-State Prefrontal fNIRS Oxygenation — Single assessment at one visit (approximately 30-minute session).
    Changes in oxy-hemoglobin and deoxy-hemoglobin concentrations in the prefrontal cortex (corresponding to Fp1, Fp2, F7, F8) measured by functional near-infrared spectroscopy (fNIRS) during 10 minutes of eyes-closed rest. fNIRS is performed once for each participant in the same 30-minute session (about 10 minutes preparation, 10 minutes recording, 10 minutes completion) in one of the three groups.
  • Resting-State Electrocardiographic Parameters — Single assessment at one visit (approximately 30-minute session).
    Electrocardiographic (ECG) characteristics recorded for 10 minutes during eyes-closed rest, using electrodes attached to the ears and both wrists, including heart rate, rhythm, and time- and frequency-domain indices of heart rate variability. ECG is measured once for each participant during the same 30-minute session (around 10 minutes preparation, 10 minutes recording, 10 minutes completion) in one of the three groups.

Trial sites (1)

FacilityCityRegionStatus
Rehab lab, Pusan National University Yangsan Hospital Yangsan Gyeongsangnam-do
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07322107 on ClinicalTrials.gov ↗ ← All trials in South Korea