Each year, between 1.6 and 3.8 million people each year suffer a mild traumatic brain injury (TBI) in the US alone. Current diagnosis and return-to-participation guidelines are based on patient symptoms, neurocognitive evaluations, and / or physical performance testing. Many of these diagnostic methods suffer from the problem of being subjective, inaccurate, or requiring baseline (before injury) due to large variations in people's inherent ability to perform in these tests. Thus the timely diagnosis is unavailable for a vast number of patients who suffer mild TBI. This project is aimed at developing an objective diagnosis of mild traumatic brain injury (mild TBI) based on physiologic changes in a patient after injury. The method is based on quantification of well-known physiologic changes after a concussion, i.e. the impairment of autonomic function and altered cerebral blood flow (CBF). The novelty of the proposed approach is the use of a recently-developed analytical framework for the analysis of the CBF velocity (CBFV) waveforms. In contrast to previous methods used before, the proposed approach utilizes the entire shape of the complex CBFV waveform, thus obtaining subtle changes in blood flow changes that are lost in other analysis methods. In Phase I of this project, feasibility of the proposed method will be demonstrated using a small study among high school athletes in the Los Angeles region. The objective of Phase I is to develop metrics that can diagnose TBI among studies with an accuracy of 90% or better. Phase II work will focus on developing a portable diagnostic device with improved accuracy, suitable for use in field applications (outside of hospitals). Successful completion of the proposed work will lead to the development of a portable, objective mild TBI diagnostic that can be used in non-clinical settings, that has the potential to vastly improve TBI patient care in all walks of life.

Public Health Relevance

Traumatic brain injury (TBI) is a serious public health problem in the United States. Each year, traumatic brain injuries contribute to a substantial number of deaths and cases of permanent disability. Mild TBI accounts for over 80% of all TBIs sustained, by both military and civilian patients. A particular problem with mild TBI incidence is the high rate of mis-diagnosis associated with it. The two main reasons for this are the lack of objective measures for quantified evaluation of the TBI, and the presentation of symptoms among subjects with delayed onset, often after several hours after primary insult. This poses serious health risks to the subjects, ranging from secondary neurological deterioration, to chronic neurological conditions as a result of inadvertent multiple sustenance of mild TBI. This project aims to develop an objective acute concussion evaluation method based on the pathophysiology, and not symptoms of mild TBI. The core principle is based on a novel analysis platform that can obtain subtle, physiologic changes in cerebral hemodynamics of the subject after a mild TBI. Successful completion of this project will results in a portable, accurate mild TI diagnostic device suitable for use in many scenarios where mild TBI diagnosis is inaccurate or unavailable today.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43NS092209-01
Application #
8906578
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Fertig, Stephanie
Project Start
2015-06-01
Project End
2016-05-31
Budget Start
2015-06-01
Budget End
2016-05-31
Support Year
1
Fiscal Year
2015
Total Cost
Indirect Cost
Name
Neural Analytics, Inc.
Department
Type
DUNS #
078766464
City
Los Angeles
State
CA
Country
United States
Zip Code
90064