xactly what repeated concussions do to the brain is a hotly debated question at the forefront of national discussion. The billion-dollar settlement with the National Football League and landmark studies about the prevalence of a serious form of brain damage known as chronic traumatic encephalopathy among NFL athletes have alarmed many that the demise of American football — all the way from the professional level to youth sports — may be on the horizon.
In the United States, an estimated 3.8 million concussions occur each year during competitive sports and recreational activities. It is difficult, if not impossible, to accurately diagnose these injuries on the sidelines immediately after they occur. Rapid detection is important because an athlete suspected of having a concussion should immediately stop playing, seek medical attention, and rest until symptoms subside completely — which may take days or months after an injury.
Two current sideline assessment tools, the Sport Concussion Assessment Tool and the Immediate Post-Concussion Assessment and Cognitive Testing, use subjective questionnaires and symptom checking, which often lead to inaccurate diagnoses of concussions or premature return-to-play decisions. Brain imaging techniques can be used to diagnoses concussion, but these can’t be employed on the sidelines.
It was once thought that monitoring the motion of a sports helmet could detect high impacts and alert an athlete to a potential concussion. Unfortunately, the “concussive threshold” has proven to be elusive and complicated. Whether that’s because of individual variability or the complexity of linear and rotational forces on the brain, so far there is no reliable algorithm based on helmet forces alone that predicts if a concussion has been sustained. That said, while recording impact forces isn’t sufficient to act as a standalone diagnostic, it does generate a large data set that can be analyzed.
A look at patents and other intellectual property for concussion detection provides some hints about where this field may be headed. Patents are often filed years before technology is ready to be marketed, providing a glimpse at possible solutions.
Of the 996 patents we reviewed, we identified 289 that disclosed objective concussion diagnostic technologies or assessments. We reviewed each of the relevant patents and broadly categorized them by the measurement(s) used for diagnosis. The three most common diagnostic categories measured brainwaves, changes in eye behavior, and biological sample levels. Here we highlight a few companies that have integrated multiple types of measurements to create multi-modal diagnostic assessments.
Patent applications filed by IBM (such as US2016/0331355, US2016/0278684, and US2016/0278693) describe a device to continuously monitor acceleration in helmets and determine when diagnostic tests should be performed. IBM’s applications include multiple diagnostic tests integrated into the helmet itself, including microphones to detect changes in speech, cameras to detect variations in the eyes’ pupils, accelerometers to detect changes in gait, and even lab-on-a-chip assays to detect biomarkers in saliva that may have been released in response to a brain injury. Other companies have also explored this multimodal approach to concussion detection.
A company called Cerora has developed a platform (US2016/0015289) that uses a head-mounted module that includes a barrage of biosensors to detect brainwave data, speech, and balance, while a front-facing camera tracks the user’s eyes, and a microphone that monitors his or her speech. It also includes an interactive test administered on a separate laptop or smart device. After performing the tests, the system sends these data via Bluetooth to be analyzed by a cloud-based server. A clinical report is generated within minutes. The company has submitted its platform, called Cerora Borealis, to the FDA for approval; it is still under review.
Another head-mounted device that employs several tests is being developed by Vivonics (US2016/0007921). This device is fitted with many biosensors and can detect two key diagnostic measures. One is the delay of information traveling from the eyes to the brain. The device flashes one or more images in front of the user’s eyes and measures the response of brainwaves. The second is intracranial pressure — the pressure of the fluid surrounding the brain. Using near-infrared sensors, the device measures this pressure by detecting the pulsing of blood vessels nourishing the brain. To be marketed as the VEP Monitor, this device has not yet been approved by the FDA.
Substances that can be identified in body fluids — cerebrospinal fluid, blood, saliva, urine, and tears — have long been seen as the magic bullet for diagnosing concussion. Many candidate molecules have been identified. These include microRNA, tau protein, glial fibrillary acidic protein, neuron-specific enolase, amyloid β, neurofilament-light/heavy, and spectrin associated fragments, to name just a few. None of these has yet been fully validated as a diagnostic biomarker of concussions.
Scientists from the University of Florida, who have formed Banyan Biomarkers, have developed a pipeline of several potential biomarkers for diagnosing concussion. While Banyan has filed many patent applications to grow its intellectual property portfolio, one recent application has a focus on an in vitro assay to test body fluids for the biomarker S-100β (US2017/0176460). This protein is a promising candidate because damaged neurons release S-100β, resulting in elevated levels of the biomarker. But there are other sources of S-100β in the body, meaning there isn’t a direct one-to-one correlation of the biomarker with the damage. In other words, S-100β levels will be elevated following nerve cell damage, but the presence of S-100β does not always mean that nerve cells have been damaged. This patent application distinguishes between several types of S100β, some of which may be more brain- or nerve-specific and lend themselves as a better diagnostic tool for concussion.
Beyond these potential point-of-care diagnostics, advanced imaging and brain testing using electroencephalography (EEG) are primarily used in hospital settings due to the complexity and expense of the equipment involved. Imaging techniques have improved to more precisely visualize structural and metabolic changes in the brain. Integrating EEG has become more common in the pre-hospital setting — on the playing field — with the use of better communication and remote servers to analyze the recordings. Examples of this technology are seen in the filings by Cerora and Vivonics.
Given how common concussions are in sport, it’s great to see that a number of companies are working to develop technology platforms to diagnose these brain injuries on the field if possible. Although researchers are looking at solutions of many kinds, they all aim to meet the same design requirements — accuracy and accessibility to provide a rapid, objective test that can be deployed immediately where the injury occurred.
These advances will also inform concussion diagnosis among members of the armed forces. More than 300,000 service members have sustained traumatic brain injuries in combat or training, and the Pentagon is seeking ways to accurately diagnose them on the spot.
As these technologies develop, a more robust understanding of the frequency and mechanics of concussions will improve our knowledge of the long-term risks and nature of traumatic brain injuries. This greater understanding of concussions and further development of products should make playing fields much safer for athletes. To support progress in concussion technologies, parents, school leaders, and athletic directors should press to transition these advances from the lab bench to the field so athletes won’t need to weigh their health against the sports they love to play.
Faith Bradley is an intellectual property strategy consultant and Daniel Currie is the group leader of the Medical Devices Group at Global Prior Art, a Boston-based company working at the intersection of intellectual property research, product development, and strategy. The authors declare no competing interests.