Pioneering Study On The Effectiveness Of Rugby Headgear In Reducing Brain Injuries To Begin In Ireland In 2023

World Rugby developed the “Law 4 Headgear Trial” framework to enable manufacturers to field test new designs of rugby headgear which may be of assistance in reducing or helping to prevent brain injuries. N-Pro is the first product to receive approval under this framework.

The study seeks to evaluate the effectiveness of the N-Pro Headguard in reducing brain injury biomarkers. The study is co-funded by the European Innovation Council and Contego Sports, the Irish company that designed N-Pro. Study recruitment will commence in the first half of 2023.

Dr O’Halloran is a Consultant Neurosurgeon at the Queen Elizabeth Hospital Birmingham and Honorary Senior Clinical Lecturer at the RCSI University of Medicine and Health Sciences.

Commenting on the launch of the study, Dr O’Halloran, said: “I am delighted to launch the Rugby Headgear Effectiveness Study today. We know that scrumcaps do not prevent players sustaining brain injuries but the World Rugby Law 4 Headgear Trial framework allows for innovation and new technologies which have shown encouraging preclinical results to be validated in the real world.

My role is to independently assess the effect of this new headgear design on brain injury using state-of-the-art blood and saliva biomarkers, neuro-imaging, instrumented mouthguards and neurocognitive tests.

We have assembled a world-leading, independent panel of scientific and medical experts in brain health and brain injury to monitor the study; it represents an important piece of the jigsaw of what is an ongoing international collective effort to protect amateur and professional players. Our attention will now turn to recruiting participants for the study. I would encourage players from clubs and schools to consider getting involved with the study”

IRFU Medical Director Dr. Rod McLoughlin commented:

“Today’s announcement is another important step forward as we learn more about the effectiveness of headgear in reducing brain injury biomarkers. This partnership reaffirms the IRFU’s commitment to making rugby a safer sport for all players and I would encourage as many participants as possible to take part in the study over the next two years. The IRFU’s approach, based on scientific evidence, involves a commitment to ongoing education, monitoring and application of safety protocols across the game and I would like to acknowledge the efforts of Dr Philip O’Halloran and World Rugby as we work together in this hugely important area of research.”

World Rugby’s Chief Medical Officer, Dr Éanna Falvey added: “We never stand still when it comes to player welfare. While standard padded headgear does not prevent head injury, we are always keen to explore advances in technology that have the potential to reduce the risk of injury. We are therefore delighted to be supporting a process that enables the assessment of headgear devices which have been designed to achieve specific, quantifiable medical purposes. We look forward to seeing the results.”

Rugby Headgear Effectiveness Study

The Rugby Headgear Effectiveness Study will take place in Ireland, in male and female rugby players aged 16 years and older, over the course of two consecutive playing seasons (from August 2023 to May 2025).

This multi-centre research study is led by global research experts in neurotrauma, neuroimaging, neurocognitive testing, blood and saliva biomarker analysis and injury surveillance.

This research team, led by Dr Philip O’Halloran, will independently evaluate if a novel head-gear design (N-Pro) can have an effect on blood and saliva biomarker levels, and other known indicators of brain injury that can be evaluated from neuroimaging (magnetic resonance imaging, MRI) scans, neurocognitive and clinical test results and accelerometer data (instrumented mouthguard), under real-world playing conditions.

Background information on the N-Pro Headguard:
• The N-Pro Headguard uses patented Defentex™ technology. It is designed to reduce the G-Force energy transferred to a player’s head during impact; one of the major factors in sports-induced brain injury. The N-Pro Headguard manages G-Force impact energy through its multi-layer construction, providing the player with an extra level of protection from injury.

Background information on the team overseeing the Rugby Headgear Effectiveness Study:

The Principal Investigator of the study is Dr Philip J. O’Halloran

• • Consultant Neurosurgeon at the Queen Elizabeth Hospital, Birmingham (U.K), Dan Rooney Concussion Fellow & Research Lead University of Pittsburgh Medical Centre (UPMC) Sports Concussion Network Ireland and Honorary Senior Clinical Lecturer at the RCSI University of Medicine and Health Sciences.
  • Dr O’Halloran is Consultant Neurosurgeon with a sub-specialty interest in Neurotrauma. He is an internationally recognized Key Opinion Leader in his field and was the recipient of the prestigious Rooney Concussion Fellowship in 2021, during which he spent time at the University of Pittsburgh Medical Centre (UPMC) Sports Medicine Concussion Program, Pennsylvania, USA. In 2020, he also became the first Royal College of Surgeons in England approved Neurotrauma Fellow at the Royal London Major Trauma Center.
  • Dr. O’Halloran is an independent match day doctor for the English Rugby Premiership and the European Rugby Champions Cup.
  • Dr. O’Halloran is an associate editor of the British Journal of Neurosurgery.

Philip has compiled an expert international team of co-investigators for the study:

• • Professor Henrik Zetterberg is a Professor / Chief Physician at the Institute of Neuroscience and Physiology at the Sahlgrenska Academy, University of Gothenburg, Sweden. Professor Zetterberg will be responsible for blood biomarker analysis.
  • Professor Tony Belli is the Professor of Neurotrauma at the Queen Elizabeth Hospital in Birmingham, United Kingdom. Professor Belli will be responsible for saliva biomarker analysis.
  • Dr. Curtis Offiah is a Consultant Neuroradiologist at the Royal London Hospital and will be responsible for the MRI scan review with the Study Principal Investigator.

The study will be overseen by a team from the IRFU:

• • Dr Rod McLoughlin, Director of Medical Service
  • Dr Nicol van Dyk, Medical Research Lead
  • Ms. Mairead Liston, Medical Manager – High Performance Game
  • Dr Caithriona Yeomans, Medical Manager – Developmental Game

A number of other researchers and groups will also contribute to the study:

• • Professor Brian Caulfield is a Director at the Insight Centre for Data Analytics, University College Dublin (UCD), Ireland. He will review accelerometer data and conduct all impact data validation analysis from the instrumented mouthguards used in this study.
  • Dr Siobhan O’Connor and Dr Enda Whyte from the School of Health & Human Performance at Dublin City University (DCU) will be responsible for assessing any behavioral changes in study participants as per World Rugby rules, by reviewing questionnaires, video footage and accelerometer data.
  • Prof Gloria Crispino is the CEO and Director of Statistica Medica Ltd, Dublin, Ireland. She will be managing the Statistical Analysis and Study Design.
  • Ms Orla Connaughton is the founder of Aztec Medical and has over 18 years’ experience in Regulatory, Design Assurance, Quality Management and Clinical Affairs.