Development and commercialisation of a next generation sports head guard, embedded with clinically validated sensors, for the detection of sports induced brain injuries.

Project Information

NProSend

Grant agreement ID: 190142218

DOI

10.3030/190142218

Project closed

EC signature date 31 March 2022

Start date 1 March 2022

End date 31 December 2024

Funded under

• The European Innovation Council (EIC)

Total cost

€ 3 311 475,00

EU contribution

€ 2 318 032,00

Coordinated by

CONTEGO SPORTS LIMITED
Ireland

Periodic Reporting for period 2 - NProSend (Development and commercialisation of a next generation sports head guard, embedded with clinically validated sensors, for the detection of sports induced brain injuries.)

Reporting period: 2023-03-01 to 2024-12-31

Summary of the context and overall objectives of the project

Head injuries have been considered an acceptable risk in sports, but they are dangerous and can lead to permanent disability and even death. Symptoms can include memory loss, confusion, and loss of consciousness. These symptoms can disappear quickly, making it easy for someone to think they have recovered; only 10% of people lose consciousness. Experiencing repeated head injuries can lead to long-term neurological complications. There is clear and compelling evidence linking sports acquired head injuries to neurological deficits including sensory impairment, decline in motor skills & neurodegenerative disorders such as dementia. Some neurological complications have no cure and progressively worsen. Early detection followed by prevention is the only solution. More than 3.8million annual sports concussion/mTBI incidents are reported in the US alone. Concussion is the most common reported match injury, contributing 22% of all injuries. Annual Concussion management and treatment costs are approx. €17B in the EU and forecasted to increase to €20B by 2030.

Building upon success of worlds 1st scientifically proven & World Rugby approved headgear 'NPro', we are evolving NPro into “NProSend” by embedding it with biomechanical and clinically-relevant physiological sensors. We have developed a proof-of-concept system with 2 digital biomarker features (concussion risk alert and an AI enabled mTBI diagnostic) to provide real-time detection of concussion by processing cumulative effects of head impacts from clinical data gathered during a trial with World Rugby.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The work programme described in DoA, was designed to accelerate the time to market, with clinical studies and product development running alongside each other. The technological gap that needed to be addressed relates to correlating head impact data with clinically relevant physiological data in “real-time”, for each individual player, in order to accurately predict a brain injury probability. Hence, the concept of NProSend.
Building upon the success of N-Pro’s superior protective effect (Defentex™), the next generation product, NProSend, was created to a prototype level by embedding it with biomechanical and physiological sensors in order to correlate accurate head impact data with clinically relevant physiological data derived from real-world player data. This data was then used to train relevant Machine Learning (ML) models, data analytics and Artificial Intelligence (AI) to generate alerts the user (or sideline medic) of concussion risk alert or an alert to seek medical attention if there is a suspected concussion in real-time.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

A proof-of-concept NProSend system was demonstrated in this project which successfully created a working prototype which integrated both biomechanical and physiological sensors into the existing NPro headgear with transmission of data to a dashboard which could generate alerts. In parallel, a library of profiles was generated from real-world head impact datasets, with computationally modelled counterparts of diagnosed concussions, which acted as a source input to train the relevant ML models identified and specifically analyse the accuracy and precision of the trained ML models used as the foundation of the development of the digital biomarkers features of NProSend described in the DoA. The results produced in this project leveraged the use of multi-modal datasets convergence with computational models of prediction from real-world clinically diagnosed events. The outcomes of this project fulfilled the objective to generate results that are beyond the current state of the art which currently solely relies on singular diagnostic adjuncts with no clinical validation for either risk identification, mTBI detection and/or diagnosis. Although the % reductions outlined in DoA are not a clinically appropriate means to determine the success of either digital biomarker feature in terms of their ability to increase the rate of detection of concussion risk, mTBI diagnosis or detection of mTBI, the continued training of the ML models from the continued data generated from NPro's post-market surveillance regulatory requirements will continue to enhance the accuracy and precision of NProSend to reach the necessary level of clinical evidence to support its regulatory submission in the next phase of commercialisation which was outside the scope of this grant-first project..