Exploratory Study on Artifact Denoising of Cerebral Blood Flow and EEG Data in Ambulance Settings

The purpose is to assess the extent of digital noise occurring during the measurement of cerebral blood flow and EEG in healthy adults within an ambulance setting and to explore the possibility of identifying and correcting abnormal patterns.

Study Overview

• Status: Not yet recruiting
• Conditions: EEG; Normal; FNIRS
• Intervention / Treatment: Other: Participants are not assigned to interventions based on a protocol.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Youjin Jeong Youjin Jeong; Phone Number: 082-055-360-4159; Email: ctccrc@pnuyh.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Normal individual

Description

Inclusion Criteria:

• Healthy adults aged 19 to 80 years.
• Individuals without chronic diseases (e.g., Stage 2 hypertension, cardiovascular disease, chronic kidney disease, chronic pulmonary disease, etc.).
• Individuals without mental health disorders (e.g., depression, schizophrenia, etc.).
• Individuals not taking medications that could affect cerebral hemodynamics, such as antihypertensives, anticoagulants, antiplatelets, antidepressants, etc.

Individuals who can read and understand the participant information and consent form and have sufficient language ability to respond to questionnaires.

- Individuals who voluntarily decide to participate in the clinical study, provide written consent on the participant consent form, and are able to participate throughout the entire duration of the clinical study.

Exclusion Criteria:

• Individuals who have experienced head trauma in the past 6 months.
• Individuals with ongoing severe chronic diseases (e.g., heart failure, chronic kidney disease, chronic pulmonary disease, etc.).
• Individuals with severe mental health disorders such as schizophrenia, severe depression, bipolar disorder, etc.
• Individuals currently taking medications that may affect the study (e.g., antihypertensives, anticoagulants, antiplatelets, antidepressants, etc.).
• Individuals who have participated in a clinical trial and taken experimental drugs within the past 30 days.
• Women who are pregnant or breastfeeding.
• Individuals who have undergone major surgery in the past 6 months.
• Individuals with acute infections or inflammatory diseases.
• Individuals with cognitive impairment or dementia.
• Individuals with neurological disorders.
• Individuals who lack understanding of the study procedures or who have not voluntarily consented to participate.
• Individuals with clinically significant findings that the study principal investigator or responsible medical personnel determines to be inappropriate for participation in this study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal	Other: Participants are not assigned to interventions based on a protocol.; Participants are not assigned to interventions based on a protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electroencephalography (EEG) signals in the ambulance	Electroencephalography (EEG) is used for measurement. Electroencephalography (EEG) is a non-invasive technique used to record the electrical activity of the brain through electrodes placed on the scalp. These electrodes detect and amplify signals generated by the synchronous activity of neurons, particularly in the cerebral cortex. EEG provides a real-time measure of brain activity with high temporal resolution, typically capturing signals in the range of 1-100 Hz.	10 minutes by boarding an ambulance in driving

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Near-Infrared Spectroscopy(fNIRS) signals in the ambulance	Functional Near-Infrared Spectroscopy (fNIRS) is a non-invasive optical imaging technique used to measure changes in brain activity by detecting hemodynamic responses associated with neural activity. It relies on the absorption properties of near-infrared light, which penetrates the scalp and skull to assess oxygenated (HbO) and deoxygenated (HbR) hemoglobin levels in cortical regions.	10 minutes by boarding an ambulance in driving

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Estimated): November 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 11-2024-058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No