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

Obelab

Status

Active, not recruiting

Conditions

Acute Ischemic Stroke Patients

Treatments

Device: Pulse oximeter, NIRSITX

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT06250608

OBE-KMT22-01

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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