Cerebro Research Unit

Clinical Literature Review

Oculomotor–Vestibular Reaction Time (OVRT) and Cognitive Metrics for Point-of-Care Assessment of Acute Mild Traumatic Brain Injury (mTBI)/Concussion

Version: 1.1

Date: December 16, 2025

Prepared for: Clinical & Regulatory Stakeholders (FDA-facing)

Prepared by: Cerebro Research Unit

Document Control and Disclaimers

Purpose: This document summarizes peer-reviewed evidence and selected regulatory/public-health sources relevant to acute, point-of-care assessment of mild traumatic brain injury (mTBI)/concussion using objective oculomotor/vestibular metrics (including OVRT batteries) and brief cognitive metrics.

Regulatory context: This review is informational and is not legal advice, nor does it represent FDA feedback or a regulatory decision.

Clinical context: mTBI/concussion remains a clinical diagnosis; objective eye movement and cognitive measures are best considered adjunctive aids to clinical assessment, not substitutes for clinician judgment or for established neuroimaging decision rules.

Executive Summary

• Acute concussion/mTBI diagnosis at point-of-care is challenging because symptom reporting is variable, neurologic exam findings can be subtle, and there is no universally accepted single “gold standard” biomarker.
• Objective eye-movement measures (eye tracking/video-oculography) and combined oculomotor–vestibular–reaction time (OVRT) batteries have demonstrated clinically meaningful discrimination between acute mTBI and controls in several prospective studies, including emergency department and military/operational contexts.
• Across OVRT and eye-tracking studies, performance varies by device, task design, population, time-from-injury, and data quality requirements. Reported diagnostic performance ranges from moderate to excellent in acute cohorts, while chronic/post-acute detection is less consistent in some datasets.
• Brief computerized cognitive metrics (e.g., reaction time, attention and memory composites) can detect group-level differences after acute mTBI, but often have smaller effect sizes than symptom measures, are vulnerable to effort/validity issues, and may be insufficient as stand-alone diagnostics.
• For FDA-facing clinical evaluation, key evidence needs include: (1) locked algorithm versioning and analytical validity; (2) prospective, blinded, multi-site clinical validation against an adjudicated reference standard; (3) prespecified performance targets and subgroup analyses; (4) usability/human factors evidence for point-of-care workflows; and (5) cybersecurity and software lifecycle documentation consistent with FDA guidance.

1. Background and Unmet Need