Authors: Courtney Johnson
A novel device, termed HS-1000, is being utilized by researchers at the Vanderbilt Sports Concussion Center (VSCC; TN, USA) in an ongoing study to devise algorithms for non-injured and concussed brains. The device relies upon detecting the resistance to soundwaves in the cranial cavity in order to measure intracranial pressure and therefore detect injury.
The current method for determining concussion injuries on the sidelines is the Sport Concussion Recognition Tool. This method observes an athlete’s behavior when answering a selection of questions and records the findings using a scorecard system. This is a subjective examination and can also be influenced by an athlete in an effort to return to the game. A similarly subjective method for the detection of concussion is also currently used by medical professionals, in the standardized SCAT3 device.
“Currently, we have to rely largely on self-report systems – what athletes are telling us as well as what we observe,” commented Allen Sills (VSCC).
The HS-1000, was developed by HeadSense Medical Inc. (OH, USA) and is extremely different from current methods for measuring intracranial pressure, which involve invasive drilling into the skull in order to place the sensors for collecting measurements.
The novel procedure takes approximately 12 minutes to complete and involves athletes placing earbuds in each ear, one containing a transmitter and the other, a receiver. Sounds waves are then sent through the cranial cavity. The set of earbuds is connected to an Android-based tablet that is programmed with the specific algorithms and software required to determine measurements of resistance encountered by the soundwaves passing through the cranial cavity. These values are then compared with normal ranges.
Regulatory approval for HS-1000 as a method for intracranial pressure monitoring has so far been granted in Europe and Israel, while approval by the US-FDA is currently pending.
“What we lack with concussions is a diagnostic tool we can hook you up to and say you definitely have one or you definitely don’t,” remarked Tim Lee (VSCC).
VSCC is at present the only center in the world working with HeadSense Inc. to investigate the efficacy of the HS-1000. Currently, the data in the study is being gathered from both female and male athletes aged between 13 and 25 years of age.
Ultimately the team hope to evaluate whether the HS-1000 is sensitive enough to detect concussions and therefore for its application to be widened from purely monitoring intracranial pressure. “Right now, we are just trying to burst through and get the healthy data,” Lee explained. “The concussion data will just come as it comes. We have two concussed athletes in the study that we’re gathering data on. I think we have probably around 25 or 30 healthy subjects. We are trying to get 50 of each.”
If approved by the FDA, the HS-1000 could have a large impact on concussion-based injuries that occur during football games, acting as a more objective and less invasive method of effectively diagnosing concussion in this environment.