Development and Multicenter Validation of a Near-Infrared Spectroscopy System for Acute Stroke Diagnosis

A Multicenter Study on Cerebral Hemodynamics Assessment in Suspected Stroke Patients Using Near-Infrared Spectroscopy - NIRS-ASSIST (Assessment of Stroke Suspected Individuals by Spectroscopy and Triage)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1032250556

Enrollment

500

Registered

2025-12-08

Start date

2025-12-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients suspected of stroke Stroke

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18 years old. Cases transported by emergency services utilizing the Ibaraki Prefecture Emergency Observation Criteria. All patients suspected of stroke by emergency medical services personnel or by the initial treating physician.

Exclusion criteria

Exclusion criteria: Patients who are pregnant. Patients requiring isolation due to suspected infectious disease.

Design outcomes

Primary

Measure	Time frame
Monitoring and analysis of changes in Delta cHb, Delta O2Hb, and Delta HHb, as well as PlsO2 and TOI data, including absolute values and inter-hemispheric differences.	—

Secondary

Measure	Time frame
To assess the diagnostic capability of various stroke scales, calculated from information obtained via the standardized Ibaraki Prefecture prehospital and emergency observation records, in classifying stroke subtypes. Furthermore, we will compare these findings with perfusion imaging software evaluations to investigate the relationship between cerebral blood flow changes and changes in hemoglobin concentrations. Finally, we will investigate the association between changes in hemoglobin concentrations and various clinical data suspected of influencing cerebral blood flow.	—

Measure

Time frame

To assess the diagnostic capability of various stroke scales, calculated from information obtained via the standardized Ibaraki Prefecture prehospital and emergency observation records, in classifying stroke subtypes. Furthermore, we will compare these findings with perfusion imaging software evaluations to investigate the relationship between cerebral blood flow changes and changes in hemoglobin concentrations. Finally, we will investigate the association between changes in hemoglobin concentrations and various clinical data suspected of influencing cerebral blood flow.

—

Contacts

Public ContactSho Okune

University of Tsukuba Hospital

sho.oku27@md.tsukuba.ac.jp+81-29-853-2951

Outcome results