StrokeNCT07322107
Prefrontal Brain Activity and ECG Patterns in Stroke and Healthy Adults
An observational study of Stroke and Healthy Participants, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Healthy Participants
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Nov 2025to 31 Dec 2026
- 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: Adults aged 19 to 80 years, including patients with intracerebral hemorrhage, patients with cerebral infarction, and neurologically healthy adult volunteers who meet the study's inclusion and exclusion criteria
Who may be able to join
- 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)
Show all 19Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Rehab lab, Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
About this study
Official title: Observation of Prefrontal Cortex Activation and Electrocardiographic Characteristics in Stroke Patients and Healthy Adults
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
Read the detailed description
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.
- Conditions
- Stroke, Healthy Participants
- Keywords
- Stroke, Cerebral blood flow, Prefrontal cortex, Electroencephalography (EEG), Functional near-infrared spectroscopy (fNIRS), Electrocardiography (ECG), Healthy Participants
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intracerebral Hemorrhage (Stroke) Group | Adults with a history of intracerebral hemorrhagic stroke. Participants undergo noninvasive measurements of prefrontal brain activity using fNIRS and EEG, and cardiac activity using ECG, to characterize neurophysiological and electrocardiographic features. | |
| Cerebral Infarction (Stroke) Group | Adults with a history of cerebral infarction (ischemic stroke). Participants receive the same fNIRS, EEG, and ECG assessments as the hemorrhagic stroke group to compare patterns of brain activation and ECG characteristics. | |
| Healthy Adult Control Group | Neurologically healthy adults without a history of stroke or major cardiovascular disease. Participants undergo identical fNIRS, EEG, and ECG measurements to serve as a comparison group for stroke patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting-State Prefrontal EEG Activity
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.
Measured: Single assessment at one visit (approximately 30-minute session).
Resting-State Prefrontal fNIRS Oxygenation
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.
Measured: Single assessment at one visit (approximately 30-minute session).
Resting-State Electrocardiographic Parameters
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.
Measured: Single assessment at one visit (approximately 30-minute session).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start6 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 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
- NCT07322107
- Sponsor's protocol ID
- 11-2025-072
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) cannot be shared due to protection of participants' personal infand regulatory restrictions of our hospital.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Prefrontal Cortex Activation and Electrocardiographic Characteristics in Stroke Patients and Healthy Adults
- ClinicalTrials.gov ID
- NCT07322107
- Acronym / sponsor ID
- 11-2025-072
- Conditions
- Stroke, Healthy Participants
- Keywords
- Stroke, Cerebral blood flow, Prefrontal cortex, Electroencephalography (EEG), Functional near-infrared spectroscopy (fNIRS), Electrocardiography (ECG), Healthy Participants
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Jan 2026 (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.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intracerebral Hemorrhage (Stroke) Group | – | –Adults with a history of intracerebral hemorrhagic stroke. Participants undergo noninvasive measurements of prefrontal brain activity using fNIRS and EEG, and cardiac activity using ECG, to characterize neurophysiological and electrocardiographic features. |
| Cerebral Infarction (Stroke) Group | – | –Adults with a history of cerebral infarction (ischemic stroke). Participants receive the same fNIRS, EEG, and ECG assessments as the hemorrhagic stroke group to compare patterns of brain activation and ECG characteristics. |
| Healthy Adult Control Group | – | –Neurologically healthy adults without a history of stroke or major cardiovascular disease. Participants undergo identical fNIRS, EEG, and ECG measurements to serve as a comparison group for stroke patients. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 19 to 80 years, including patients with intracerebral hemorrhage, patients with cerebral infarction, and neurologically healthy adult volunteers who meet the study's inclusion and exclusion criteria
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resting-State Prefrontal EEG Activity
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.
Resting-State Prefrontal fNIRS Oxygenation
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.
Resting-State Electrocardiographic Parameters
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.
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 7 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) cannot be shared due to protection of participants' personal infand regulatory restrictions of our hospital.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Healthy Participants, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
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 19 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting-State Prefrontal EEG Activity (time frame: Single assessment at one visit (approximately 30-minute session).). The study lists 3 primary outcomes in all. 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 7 Jan 2026.