The Apex

As we settle into autumn and turn our collective consciousness to American football, we are reminded of the ever-present risk of physical injury, particular to the head. A flurry of media reports and clinical studies in recent years have highlighted concerns about traumatic brain injury (TBI) and its long-term effects on players. Fortunately, this focus is also leading to the development of new technologies geared toward early detection and diagnosis of brain injury.

According to the Centers for Disease Control (CDC), a TBI is caused by a “bump, blow, or jolt to the head that disrupts the normal function of the brain” and can range from mild to severe. Most TBIs are mild, and are commonly called concussions.[1] In the United States, there are approximately three million TBIs reported each year. From 2007-2013, TBI-related emergency department visits increased by 47%. An estimated 400,000 children (age 19 or younger) suffer a sports-related concussion each year. Moreover, the U.S. military has reported more than 361,000 TBIs since the year 2000.[2] The leading causes of TBI are: (i) falls, (ii) being struck by or against an object, and (iii) motor vehicle accidents.

Heightened awareness and publicity – such as studies of former NFL players and military personnel – have led to calls for more focus on early detection and prevention. Most high school, college and professional teams now have trainers or physicians on the sidelines who are required to identify possible concussions and perform cognitive tests on players before they are allowed to continue. In the U.S. military, commanders are closely monitoring concussions and implementing protocols to remove injured personnel from the battlefield.

Medical technology companies are also aggressively testing and developing new products to facilitate early detection of TBIs, under the rationale that it will allow trainers, coaches, and commanders to identify injured persons before further damage can be done. Experts agree that secondary concussions can be worse and lead to long-term damage. The other challenge is that players/soldiers may be reluctant to self-report head injuries, for fear of losing their position or appearing “weak.” While that culture is slowing changing with public education and awareness, medical personnel need more objective tools to support their decisions.

The products in development today can be grouped in several categories, including impact sensors, biomarkers, ocular tests, and brain activity devices.

Impact Sensors

Impact sensors are devices used to detect acceleration and motion of the head upon contact. While the results may not definitively identify a TBI, coaches and trainers can use the data to judge when a player should come off the field (similar to how pitch counts are used in baseball). For instance, leading football helmet manufacturer Riddell has developed the InSite Impact Response System, which includes a five-zone sensor pad inserted into the liner of the helmet. The pad measures impact severity and sends an alert when a single hit or sequence of hits exceeds a specified threshold. A number of other companies have developed similar products, either for placement in a helmet, mouth guard, or directly on the skin. 

Biomarkers

Blood and saliva biomarkers can be used to detect proteins that may indicate that a TBI has occurred. At least two companies are in active development of products in this area. Massachusetts–based start-up Quanterix has developed tests that can detect small amounts of proteins in the blood, using antibodies that bind to specific molecules. San Diego-based Banyan Biomarkers is developing a rapid-detection blood test to distinguish two biomarkers linked to TBI, ubiquitin c-terminal hydrolase-L 1 (UCH-L1) and glial fibrillary acidic protein (GFAP). Among the objectives of these products is to reduce the number of CT scans following injury.

Ocular Tests

Simple eye-tracking technology may be a low-cost and efficient means to detect concussions. Studies have shown that patients with suspected TBI have much less control of eye movement than they would under normal conditions. Pittsburgh-based Neuro Kinetics has been working with the medical schools of the University of Miami and University of Pittsburgh to develop goggles that can be used to monitor an athlete’s eye movements and eye responses. The resulting data is used to determine how the brain and balance systems are working and detect aberrations. Another company in this area is BLINKtbi, which has developed a similar test in collaboration with the Medical University of South Carolina.

Brain Activity Devices

Studying brain activity and auditory stimuli can help detect patterns that identify brain injury. As with most tests of this type, the challenge has been to create portable devices that can be used on the sideline or battlefield. Bethesda, MD-based BrainScope has been working with researchers at the Johns Hopkins University School of Medicine to develop a hand-held EEG device that can monitor a person’s electrical brain activity and transmit data to a smartphone. Within five minutes, the device is capable of assessing a head injury, and with 97% accuracy, advise doctors whether to order further tests or treatment.

CONCLUSION

It is too early to say which of these devices will be successful, as more data and testing will be required to determine efficacy (not to mention commercial viability). However, the good news is that companies are now, more than ever, focused on developing accurate and reliable products that can be used to detect TBIs on the sidelines / battlefield. Early detection will reduce the number of more serious cases, and hopefully, cut down on the long-term effects of repetitive blows to the head.

Footnotes

[1] Centers for Disease Control and Prevention (CDC), https://www.cdc.gov/traumaticbraininjury/get_the_facts.html, 2017

[2] Defense and Veterans Brain Injury Center, http://dvbic.dcoe.mil/dod-worldwide-numbers-tbi