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

November 20, 2024 updated by: Yong-il Shin, Pusan National University Yangsan Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Youjin Jeong Youjin Jeong
  • Phone Number: 082-055-360-4159
  • Email: ctccrc@pnuyh.co.kr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Electroencephalography (EEG) signals in the ambulance
Time Frame: 10 minutes by boarding an ambulance in driving
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Near-Infrared Spectroscopy(fNIRS) signals in the ambulance
Time Frame: 10 minutes by boarding an ambulance in driving
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pusan National University Yangsan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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