SBIR-STTR Award

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 Statement:


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.

Project Terms:
Accounting; Acute; Address; Algorithms; Area Under Curve; balance testing; base; Beds; Blood; Blood flow; Blood Flow Velocity; Brain Concussion; Breathing Exercises; Carbon Dioxide; cerebral artery; cerebrovascular; Cerebrovascular Circulation; Cerebrum; Cessation of life; Chronic; Complex; Core-Binding Factor; Deterioration; Development; Devices; Diagnosis; Diagnostic; diagnostic accuracy; Diagnostic Procedure; disability; Evaluation; Functional disorder; Grant; Guidelines; Health; hemodynamics; high school; Hospitals; Hour; Hyperventilation; Impairment; improved; Incidence; indexing; Injury; Institutional Review Boards; Lead; Life; Los Angeles; Measures; Methods; Military Personnel; Neurocognitive; Neurologic; novel; Outcome; Patient Care; Patients; Performance; performance tests; Phase; Physiological; Procedures; Protocols documentation; public health medicine (field); public health relevance; response; Risk; Sensitivity and Specificity; Series; Shapes; Sports; Stimulus; Symptoms; System; Systems Development; Testing; Traumatic Brain Injury; United States; Variant; Vascular constriction (function); Vasodilation; Walking; Work

Between 1.6 and 3.8 million people each year suffer a mild TBI in the US alone. Reliable diagnosis and prompt treatments are vital to managing the often-serious short and long-term sequelae resulting from mild TBI. However, a reliable objective and accurate method for mild TBI diagnosis outside of a hospital setting, and in particular for determining RTP readiness, has eluded the clinical community. Current diagnosis and RTP assessments are based on patient symptoms, neurocognitive evaluations, and / or physical performance testing. Use of symptom scales are problematic for several reasons including subjectivity and reliability. Neurocognitive evaluations and physical tests (such as balance tests), although less subjective, require pre- injury baseline testing of subjects due to inherently large subject-to-subject variations in evaluation performances. Due to these reasons, current mild TBI diagnostic methods have limited applications and are not suitable for a significant majority 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 and providing a platform capable of RTP guidance. 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) as measured with transcranial Doppler (TCD). The novelty of the proposed approach is the use of a recently-developed analytical machine learning 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 that are lost in other analysis methods. Additionally, comprehensive verification between our platform and MRI will be performed following injury resulting in the first scientific experiments of this kind. The ultimate goal of this Phase II SBIR is to commercialize an objective and accurate software algorithm for reliable diagnosis and management of sports concussions which does not currently exist. The outcome will be a software suite integrated into existing TCD and will be marketed to emergency departments, neurology clinics, and other healthcare providers involved in mild TBI diagnosis and RTP management.

Public Health Relevance Statement:
Project Narrative Traumatic brain injury (TBI) is a serious public health problem in the United States contributing to a substantial number of deaths and cases of permanent disability. Mild TBI concussions account for over 80% of all TBIs sustained and a major problem is the high rate of mis-diagnosis due to lack of objective measures and delayed onset of symptoms. This project aims to develop the first objective concussion evaluation method using a novel analysis platform that can obtain subtle, physiologic changes in cerebral hemodynamics. Successful completion of this project will result in a portable diagnostic device suitable for use in many scenarios where concussion diagnosis is inaccurate or unavailable today.

NIH Spending Category:
Bioengineering; Brain Disorders; Cerebrovascular; Clinical Research; Diagnostic Radiology; Injury (total) Accidents/Adverse Effects; Injury - Trauma - (Head and Spine); Injury - Traumatic brain injury; Neurosciences

Project Terms:
abstracting; Accident and Emergency department; Accounting; Acute; Adoption; Algorithmic Software; Algorithms; Area Under Curve; Assessment tool; balance testing; base; Blood flow; Blood Flow Velocity; Brain Concussion; brain health; cerebral hemodynamics; Cerebrovascular Circulation; Cessation of life; Classification; Clinic; Clinical; Clinical Data; clinical Diagnosis; Clinical Research; Collaborations; Communities; Complex; Computer software; Controlled Study; Core-Binding Factor; Data; Data Analytics; Data Collection; Development; Devices; Diagnosis; Diagnostic; diagnostic accuracy; Diagnostic Procedure; disability; Evaluation; Functional disorder; Future; Goals; Gold; Guidelines; Health Personnel; hemodynamics; high school; Hospitals; Image; Impairment; injured; Injury; innovation; Letters; Licensing; Machine Learning; Magnetic Resonance Imaging; Marketing; Measures; Methods; mild traumatic brain injury; Modeling; Neurocognitive; Neurologist; Neurology; novel; Outcome; Patients; Pediatric Neurology; Performance; performance tests; Persons; Phase; Physical Performance; Physicians; Physiological; Play; prevent; programs; Public Health; Publications; Readiness; Recovery; relating to nervous system; Research; research study; Resolution; Risk; Severities; Shapes; Site; Small Business Innovation Research Grant; Spin Labels; Sports; Sports Medicine; success; Symptoms; Syndrome; System; Technology; Testing; Time; tool; Training; Traumatic Brain Injury; Ultrasonography; United States; Variant