This prospective clinical study has been funded by the Congressionally Directed Medical Research Programs (CDMRP) to address military research gap areas associated to mild traumatic brain injury (mTBI) including: 1) screening, evaluation and diagnosis; and 2) diagnostic methods and biomarkers.?? In mTBI, there is a need for an objective and quantitative testing system that can be performed at the site of injury, longitudinally track the natural history of the condition, and provide reproducible quantitative comparisons. This study will define the visual and oculomotor testing battery (i.e., objective biomarkers) required to identify Warfighters in the acute setting whom are suspected of sustaining an mTBI. The ultimate endpoint will be accomplished through the completion of two specific aims based on quantifiable metrics and acquisition planning. Specifically, the proposed study aims will: 1) Quantitatively assess subjects?? visual functions data on n = 200 controls and n = 200 subjects with a diagnosis of acute phase (?? 72 hrs) mTBI; 2) Evaluate the sensitivity and specificity of the Neuro-Ophthalmic Device (NODe) acute mTBI test battery.
quantitatively assess subjects' visual functions data on n = 200 active duty controls and n = 200 active duty personnel with a diagnosis of acute phase (< 72 hours) mTBI; (2) evaluate the sensitivity and specificity of the Neuro-Ophthalmic Device (NODe) acute mTBI test battery; and (3) develop a NODe strategic roadmap for future clinical and operational translation capabilities.Study Design: The prospective clinical study will assess the subjects' visual function in n = 200 controls and n = 200 personnel with a diagnosis of acute mTBI. Active duty personnel receiving medical care following a head injury (acute mTBI cases) and active duty personnel seen in the Optometry Department (age- and gender-matched controls) at Womack Army Medical Center on Ft. Bragg will be evaluated in this study. Supplementary testing will include an intake questionnaire at the Acute Concussion Care Clinic, SCAT-3 symptom assessment and cognitive testing, ANAM reaction time testing, a full ophthalmic exam including oculomotor evaluation, and the Convergence Insufficiency Symptom Scale (CISS) assessment. NODe data will be evaluated for sensitivity and specificity in the acute mTBI population.