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

NCT06701708 | Not Yet Recruiting

• 1 other identifier: 11-2024-058
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Normal; EEG; FNIRS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Functional Near-Infrared Spectroscopy(fNIRS) signals in the ambulance

  10 minutes by boarding an ambulance in driving

Study Arms (1)

Normal

Other: Participants are not assigned to interventions based on a protocol.

Interventions

Participants are not assigned to interventions based on a protocol. OTHER

Participants are not assigned to interventions based on a protocol.

Normal

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

Normal individual

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Central Study Contacts

Youjin Jeong Youjin Jeong

CONTACT

082-055-360-4159; ctccrc@pnuyh.co.kr

Study Design

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

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share