Measuring brain oxygen levels in stroke patients using a special device
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, Single-center, Non-randomized, Open-label, Exploratory Clinical Trial.
This study is testing a special device to see if it can measure oxygen levels in the brains of adults who have had a recent stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | OBELAB, Inc. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06250608 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates cerebral oxygen saturation (rSO2) in acute ischemic stroke patients by comparing values from the frontal lesion area to a normal brain area using a pulse oximeter equipped with near-infrared spectroscopy (NIRSITX). The study aims to determine the differences in oxygen saturation levels to assess the efficacy and safety of this measurement technique. Participants must be adults diagnosed with acute ischemic stroke within a week of symptom onset and must provide consent to participate. The trial will also explore the potential for further clinical investigations based on the findings.
Who should consider this trial
Good fit: Ideal candidates are adults over 19 years old who have been diagnosed with acute ischemic stroke within 7 days of symptom onset.
Not a fit: Patients without brain imaging results or those with conditions like jaundice or skull fractures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of cerebral oxygenation in stroke patients, leading to improved treatment strategies.
How similar studies have performed: While this approach is innovative, similar studies using NIRS for monitoring cerebral oxygenation in stroke patients have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Tae Jung Kim
- Email: ttae35@gmail.com
- Phone: 82-2-2072-1810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.