INTELLIGENT MOUTHGUARD FOR MEASURING HEAD IMPACTS IN YOUTH ATHLETES

Sportsguard Laboratories, Inc., Kent OH

Investigators

Linked publications & trials

Abstract

DESCRIPTION (provided by applicant): With 53 million young athletes participating in contact sports, and between 173,000 to 3.8 million concussions endured by young athletes yearly in the US, subjective concussion identification increases risk of death, time lost from school, cognitive decline, chronic traumatic encephalopathy (CTE), depression, suicide, dementia, Alzheimer's and Parkinson's Diseases. However, frontline caregivers lack an objective way to identify potentially concussed young athletes, instead relying on subjective identification or self-reported symptoms. Because of this significant clinical gap, young athletes evade evaluation to play when injured, dying after sustaining undiagnosed concussions and possibly damaging their long-term brain health due to cumulative head impacts. The goal of this project is to reduce the incidence and consequences of sport-related concussion and sub-concussive impacts in young athletes via commercialization of a low-cost wireless Intelligent Mouthguard head impact dosimeter. This innovation will finally provide frontline caregivers with a low-cost, accurate tool to identify all at-risk athletes in real-time in helmeted and non-helmeted sports so they may be removed from play for further assessment. On a longer term the goal is to define the relationship between cumulative sub-concussive head impacts and risks of decline in brain health. The Phase I hypothesis is that an accurate wireless sensing package can be fully embedded into an athletic mouthguard and transmit head impact data over 25 meters within safe human radiation exposure limits. The Phase I Specific Aim is to identify and test combination(s) of off-the-shelf kinematic sensors, batteries and wireless transmitters that meet cost, transmission distance, power budget, battery life, radiation emitted, accuracy and intra-oral volume requirements. Sensors will be tested in a benchtop apparatus that will quantify accuracy and precision under concussion-like conditions. Batteries will be tested quasistatically to determine resistance to human jaw crush forces. Wireless data transmission distance versus radiation emission will be quantified. A young athlete focus group will provide feedback on acceptable intra-oral sensing package volume. A wireless prototype will be built and tested using a custom in vitro linear impactor and anthropomorphic headform. And dynamic impact tests will benchmark data collection accuracy versus gold-standard reference crash dummy. Any combination of low cost components, rechargeable battery lasting 240+ minutes, wireless transmission at least 25 meters, radiation emission below FCC limits, volume less than 4000mm3 and acceptable accuracy versus reference will define success. At the conclusion of this Phase I STTR it is anticipated that a selection grid of several combinations of available off-the-shelf components meeting Specific Aim success criteria will be defined. At least one design will be ready for Phase II prototyping and clinical trial tests. Domestic markets account for gross sales of approximately $27 million for the Intelligent Mouthguard within 3 years post- commercialization. International markets will potentially increase sales.