Evaluation of rSO2 Between Frontal Lesion Area and Normal Area of Brain by NIRSITX Using NIRS in Acute Ischemic Stroke Patients.

The clinical trial is for acute ischemic stroke patients measuring cerebral oxygen saturation (rSO2) values using pulse oximeter of near-infrared spectroscopy in the frontal lesion area and normal area of brain. The purpose of the clinical trial is to compare differences in cerebral oxygen saturation values, and the efficacy and safety are evaluated through additional exploratory clinical trials.

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Key information

Conditions

Acute Ischemic Stroke Patients Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital, Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults over age 19
Patients diagnosed with acute ischemic stroke within 7 days of symptom onset
Patient's condition confirmed to have an acute ischemic stroke and also brain blood vessels condition confirmed through brain imaging such as Brain CT/CTA/CT perfusion and Brain MRI/MRA
Patients voluntarily agree to participate and scheduled to participate in this clinical trial
Patients willing to comply with the clinical trial protocol

Exclusion criteria

Patients without brain imaging result
Patients diagnosed with jaundice (hyperbilirubinemia) with abnormal skin color - Patients who find it difficult to wear medical devices for clinical trial on their foreheads
Patients who has skull fractures of external shape not maintained normal
Patients who does not agree to participate in this clinical trial
Patients who are currently participating in another clinical trial or have participated in another clinical trial within 30 days of the screening date
Patients who is determined from investigator that participating is inappropriate because it may affect the results of the clinical trial or ethically

Treatment and study plan

Pulse oximeter, NIRSITX

Device

It is a device that non-invasively continuously monitors blood oxygen saturation (rSO2) in localized areas of the brain. This device is attached to patients with symptoms suspected of stroke or diagnosed with stroke to continuously monitor the level of oxygen supply to the brain.

Primary outcomes

Comparison of rSO2 values obtained from NIRSITX, a medical device for clinical trials, between the frontal lobe on the side with brain lesions and the frontal lobe on the contralateral side.

Time frame: Baseline and follow-up (24 hours later)

The number of study subjects, mean, standard deviation, median, minimum, and maximum are presented as descriptive statistics for the difference and rate of change in rSO2 values obtained from medical equipment for clinical trials between the frontal lobe on the side with the brain lesion and the frontal lobe on the contralateral side. The statistical significance of the change in rSO2 values between two areas is tested using the t-test or Wilcoxon test.

Sponsors and collaborators

Lead sponsor

OBELAB, Inc.

Industry

Collaborators

Helptrial Inc.

Registry information

Official study title

Evaluation of Cerebral Oxygen Saturation(rSO2) Measurements Between Frontal Lesion Area and Normal Area of Brain by Pulse Oximetry(NIRSITX) Using Near-infrared Spectroscopy in Acute Ischemic Stroke Patients, Prospective, Multi-center, Non-randomized, Open-label, Exploratory Clinical Trial.

Acronym: fNIRS

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Feb 9, 2024
Registry last updated: Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed