David Camarillo - US grants

DESCRIPTION (provided by applicant): Concussion is a widespread problem in the military and in sports, with over 1 million estimated sports related concussions occurring in the U.S. each year. However, the mechanism of injury, and therefore diagnosis, is not well understood. Diagnosis of concussion is notoriously difficult because the symptoms, and their interpretation by physicians, are highly variable and subjective. An even greater challenge is that rarely do youth sporting events have trained medical personnel to identify and evaluate injured athletes. Proper management of injury is essential to avoid short-term risks such as re- injury, or even brain hemorrhage, as well as long-term risks ranging from cognitive deficits to dementia. Therefore, an unbiased and quantitative measure of concussion in real-time is needed to prevent further injury. This proposed project centers on the use of a novel instrumented mouthguard that will be worn by collegiate football players in practice and in games to measure three axes of both linear and rotational acceleration. Recent research emphasizes the potential importance of rotational acceleration in concussions as well as the importance of cumulative impacts in long-term neurodegenerative diseases. We hypothesize that this mouthguard can accurately detect magnitudes of linear and rotational acceleration of the head as well as record head impact events that occur during play. The goal of this R21 proposal is to appropriately confirm this hypothesis both in laboratory and on the field. This will enable larger studies to be performed that may better elucidate the mechanism of concussive injury and the risk of neurodegenerative disease. We will do so through the following specific aims: (1) Validate mouthguard kinematics in the laboratory using an instrumented dummy head and (2) Verify impact detection in vivo using practice and game video. In order to validate the mouthguard, head acceleration measurements from mouthguard will be compared to data captured by the instrumented dummy head while undergoing a standard head impact test. In addition, high-speed speed video captured in practice will be used to reconstruct real impacts in 3D to assess validity of laboratory head impact system. Finally, head impact events from mouthguards will be confirmed using game video to modify post-process algorithms in order to optimize the accuracy in detecting real head impact events. Achieving these 2 aims will be the basis for future multi-site clinical studies on the mechanism of traumatic brain injury in multiple sports.

The objective of this proposal is to disseminate mouthguard sensors to a community of researchers studying the short- and long-term effects of head impacts on brain health. Traumatic brain injury (TBI) has long been known to be a leading cause of death and disability among children and young adults. However, it has only recently been argued that concussion, a form of ?mild? TBI, increases the risk for Alzheimer's and other neurodegenerative diseases. Understanding the mechanisms of concussion is crucial for injury diagnosis and prevention. However, past research efforts have been unable to identify a clear link between head impact acceleration dose and neurological response indicative of injury. This is mainly due to the lack of a large, high quality concussion dataset. The difficulty in measuring rare injury scenarios has hampered individual investigators from making substantial progress. Thus the required dataset can only be gathered through large- scale, multi-institution dissemination of a validated head impact measurement sensor. We propose to widely disseminate our rigorously validated Stanford mouthguard (MiG2.0), and subsequently develop a platform to share collected data among many investigators. The MiG2.0 is a unique design that rigidly couples to the skull through upper dentition. This project will disseminate the MiG2.0 to a large community of concussion researchers that study high injury rate populations such as contact sports players. At the end of the project, we will have a large concussion database with accurate head impact measurements that will further our understanding of concussion mechanisms. Our long-term goal is that the knowledge gained from this dissemination effort will improve concussion management and long-term brain health by enabling (1) real-time field diagnosis, and (2) design improvements in protective equipment for athletics, the military, transportation and other high-risk activities.

PROJECT SUMMARY Head injuries, including nearly 4 million concussions per year, are common among the nearly 40 million participants in organized youth sports in the United States. Despite recent technologies marketed to reduce concussion risk, head injuries continue to rise among youth athletes. Furthermore, studies to improve protective equipment have largely focused on adult populations, leading to athletic equipment optimized for protection against the risk of catastrophic injuries from severe high-energy collisions. Protective equipment is needed that provides maximal protection across a wider range of impact energies including the lower, yet still dangerous, impact energies experienced at the youth level. Creating youth-specific helmets is essential for tackling the concussion epidemic among this vulnerable population of athletes. SoftShock is a novel shock absorber which manages impact energy to result in generally lower force levels than traditional foams used in helmets, giving it the potential to drastically reduce the risk of brain injury. We propose to integrate SoftShock technology into a youth football helmet to show the feasibility of the technology, afterwards expanding into broader markets such as bicycling, equestrian, child car seats, playground fall surfacing, and more. In this Phase I proposal, we are requesting funding to target the principal requirements for successful implementation of SoftShock technology in a youth helmet: 1) helmet comfort and fit 2) shock absorber unit weight and robustness, and 3) helmet performance. The completed helmet prototype from Phase 1 proposal will lead to a Phase II submission on the first ever prospective clinical study of a football helmet with the goal of having the first helmet validated to reduce the risk of concussion among youth. Specific Aim 1: Develop comfortable and well-fitting helmet interiors A detailed finite element model of our helmet will be used to determine the necessary size, placement, and distribution of SoftShocks in order to maximize head comfort and helmet fit across a range of youth head sizes. Specific Aim 2: Manufacture lightweight, durable, and recoverable shock absorbing units Softshock will be manufactured and unit tested to ensure that its weight, multi-impact durability, and recovery time meets or exceeds that of standard foams and air shocks. Specific Aim 3: Test helmet prototypes for performance SoftShocks will be integrated into a lightweight helmet shell, creating prototypes to be tested in standard certification protocols to demonstrate superior performance across a wide range of impact energies as compared to existing youth football helmets.