In current clinical practice, diagnosis of mild traumatic brain injury (mTBI)/concussion and decision-making regarding return-to-school/play/work rely heavily on self-reported symptoms and/or on other neurocognitive tests/assessments. These assessments require baseline testing, which is not commonly done, thus greatly limiting their usefulness. Additionally for the pediatric population, continuous and rapid brain development suggest baseline testing should be done more frequently than in adults. Therefore, there is a large unmet need for developing appropriate tools to evaluate brain dysfunction and recovery following mTBI/concussion that are not baseline dependent and take into account age-dependent maturational changes. Eye movement has been traditionally used as a non-invasive observational tool for understanding neural development. Neuro Kinetics? FDA-cleared I-Portal technology assesses oculomotor, vestibular, reaction time and cognitive (OVRT-C) capabilities and provides a highly accurate objective measure of neural functions and brain injury-induced disturbances. The technology consists of head mounted virtual reality goggles equipped with high speed cameras to capture eye movements, a battery of specific OVRT-C tests that probe different parts of the brain and a software platform, called VESTTM, that uses sophisticated algorithms to provide OVRT-C parameters that quantify neural performance. This application seeks funding for extending the applicability of this technology to the pediatric population. Phase I of the application is to develop a new child prototype goggle and age appropriate software instructions, design and algorithms. Phase II is to collect normative OVRT-C data from healthy males and females, ages 8 to 18. This database will reflect normal development as reported by the OVRT-C tests and will serve as a tool for evaluating effects of mTBI/concussions, monitoring recovery and aiding in the return-to-school/play decision. Additionally, it can serve as an objective screening tool for mental health and neurological conditions that start early in childhood, as well as for assessing treatment efficacy.

Public Health Relevance

Oculomotor, vestibular, reaction time and cognitive (OVRT-C) assessments can provide objective measures of neural development. This grant proposes to construct a normative OVRT-C database for pediatric populations, ages 8-18, that will help clinicians understand the natural history of neural functional development from ages 8 to 18 and aid in the identification of brain deficits when compared to norms from the appropriate age and gender groups that evolve from this study. These norms can be put to immediate use for mild traumatic brain injury (mTBI)/concussion detection, minimizing, or potentially eliminating, the need for baseline testing and possibly serve as a return-to-school/play decision tool.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
1R44HD100247-01
Application #
9845544
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Maholmes, Valerie
Project Start
2019-09-01
Project End
2020-08-31
Budget Start
2019-09-01
Budget End
2020-08-31
Support Year
1
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Neurolign USA, LLC
Department
Type
DUNS #
City
Pittsburgh
State
PA
Country
United States
Zip Code
15238