SBIR-STTR Award

Development of a Pediatric Oculomotor and Vestibular Normative Database as an Essential Tool for Objective Evaluation of Concussion and Return-To-School/Play
Award last edited on: 6/9/20

Sponsored Program
SBIR
Awarding Agency
NIH : NICHD
Total Award Amount
$224,999
Award Phase
1
Solicitation Topic Code
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Principal Investigator
Alexander D Kiderman

Company Information

Neuro Kinetics Inc (AKA: NKI~Neurolign USA LLC)

128 Gamma Drive
Pittsburgh, PA 15238
   (412) 963-6649
   info@neuro-kinetics.com
   www.neuro-kinetics.com
Location: Single
Congr. District: 17
County: Allegheny

Phase I

Contract Number: 1R44HD100247-01
Start Date: 9/1/19    Completed: 8/31/20
Phase I year
2019
Phase I Amount
$224,999
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 Statement:
Project Narrative 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.

NIH Spending Category:
Behavioral and Social Science; Bioengineering; Brain Disorders; Clinical Research; Injury (total) Accidents/Adverse Effects; Injury - Childhood Injuries; Injury - Trauma - (Head and Spine); Injury - Traumatic brain injury; Injury - Unintentional Childhood Injury; Mental Health; Networking and Information Technology R&D (NITRD); Neurosciences; Pediatric

Project Terms:
accurate diagnosis; Adult; Age; age group; age related; Algorithms; Anatomy; Assessment tool; Attention; Attention deficit hyperactivity disorder; autism spectrum disorder; base; Behavior; Brain; Brain Concussion; brain dysfunction; Brain Injuries; Cause of Death; Child; Child Development; Childhood; Clinical; clinical practice; Cognition; Cognitive; cognitive testing; cohort; Computer software; computerized; Computers; Data; Databases; Decision Making; design; Detection; Development; Devices; Diagnosis; disability; Documentation; drug development; Ensure; Evaluation; Eye; Eye Movements; Face; Feedback; Female; follow-up; Funding; Future; Gender; Goals; Goggles; Grant; Head; Hospitalization; Institutional Review Boards; Instruction; Kinetics; Laboratories; male; Measures; Memory; Mental Health; mild traumatic brain injury; Monitor; Movement; Natural History; Neural Pathways; neurocognitive test; neurodevelopment; Neurologic; Neurophysiology - biologic function; oculomotor; Pathology; Patient Self-Report; Patients; pediatric traumatic brain injury; Performance; performance tests; Phase; Play; Population; portability; Production; Protocols documentation; prototype; psychologic; Reaction Time; Recovery; Reflex action; relating to nervous system; Reporting; research clinical testing; response; Running; scale up; Schizophrenia; Schools; Screening procedure; Sensitivity and Specificity; Speed; Stimulus; Structure; Symptoms; System; Technology; Testing; therapy development; Time; tool; Traumatic Brain Injury; Treatment Efficacy; virtual reality; Wo

Phase II

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
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Phase II Amount
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