Rehab lab, Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612, South Korea
NCT Number: NCT07322107
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
This study is active but is not currently recruiting participants.
Notify Me19 year–80 year
All sexes
Observational
Yangsan, Gyeongsangnam-do, 50612, South Korea
This study is an observational investigation designed to characterize neurophysiological and cardiovascular features in adults with a history of stroke and in age-matched healthy controls. Participants will undergo noninvasive measurements of brain activity using functional near-infrared spectroscopy (fNIRS) and electroencephalography (EEG), focusing on prefrontal cortical responses during resting and simple task conditions. Electrocardiography (ECG) will be recorded concurrently to assess heart rate and rhythm characteristics, including temporal and spectral ECG parameters.
The primary objective is to compare patterns of prefrontal brain activation and ECG characteristics between stroke patients and healthy adults, exploring potential associations between altered cortical activity and cardiac autonomic regulation after stroke. Secondary aims include examining relationships between brain signals, ECG features, and clinical factors such as stroke severity or functional status in the patient group. Results from this study may help to generate hypotheses for future interventional research and to identify physiological markers useful for monitoring recovery or risk stratification in stroke survivors.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Pusan National University Yangsan Hospital
Other
Observation of Prefrontal Cortex Activation and Electrocardiographic Characteristics in Stroke Patients and Healthy Adults
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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