Prefrontal Brain Activity and ECG Patterns in Stroke and Healthy Adults

NCT07322107 | Active Not Recruiting

• 1 other identifier: 11-2025-072
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Stroke; Healthy Participants

Keywords

Stroke; Cerebral blood flow; Prefrontal cortex; Electroencephalography (EEG); Functional near-infrared spectroscopy (fNIRS); Electrocardiography (ECG); Healthy Participants

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Single assessment at one visit (approximately 30-minute session).

Study Arms (3)

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.

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

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Rehab lab, Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: November 6, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)