400 Section - Combination iSTAT/Alinity & Video Infrared Oculography for Head Computed Tomography (CT) Necessity and Recovery Prediction after mild Traumatic Brain Injury (mTBI)

Mild traumatic brain injury (mTBI) is common yet underdiagnosed in emergency care, where computed tomography (CT) imaging lacks sensitivity for functional deficits. This pilot evaluates a dual-modality diagnostic pathway, combining point-of-care brain biomarkers (GFAP, UCH-L1 via i-STAT Alinity; FDA-cleared) and infrared video oculography (IVOG) (DeCon) to improve detection of clinically meaningful deficits and support more precise triage.The goal is to improve triage, reduce unnecessary imaging, and guide timely referrals. Findings will inform feasibility and design for multisite trials.




Design:

This prospective pilot study at FHCC-Lovell VA (USA) is enrolling 50-80 adult patients with physician-confirmed mTBI (GCS 13–15, ≤12 hours post-injury). Participants undergo biomarker testing and IVOG at baseline, 2 and 4 hours post-injury, and ED discharge. CT scans are obtained at clinician discretion. Study data is blinded to treating teams. Follow-ups at 7, 14, 30, and 60 days include Rivermead assessments. Institutional approvals, device validation, and secure data workflows are in place.




Results:

Twelve patients have been enrolled and completed the protocol. Oculography revealed impairments in saccades, reaction time, and vergence correlated with early symptoms. Most CT-negative patients had normal biomarkers, while one CT-positive patient exhibited elevations, aligning with prior evidence. In several cases, oculography detected deficits even when CT and biomarkers were negative, highlighting its added sensitivity. Interim analysis will assess diagnostic accuracy (AUC, sensitivity, specificity, NPV), testing feasibility, and potential CT reduction using decision-curve modeling.




Conclusion:

This pilot supports a scalable, multimodal ED triage pathway for mTBI using real-time biomarker and functional metrics. Findings suggest that combining IVOG with point-of-care biomarkers can detect impairments missed by CT, reduce unnecessary imaging, and enable earlier rehab referrals. This model supports international goals for imaging stewardship and neuro-rehab access, especially in resource-variable settings. Next steps include refining thresholds, validating outcomes in multisite trials, and evaluating broader applicability across trauma and rehabilitation systems worldwide.