- Harvard University researchers are ready for large-scale testing of an mHealth device that could detect traumatic brain injury from a drop of blood.
The researchers are working with Boston-based mobile health device company BioDirection to create a diagnostic device that analyzes a blood sample for proteins released when the brain experiences a hard hit. The device, called a Tbit (traumatic brain injury test), is reportedly about the size of a loaf of bread, and analyzes a drop of blood collected in small cartridge in less than two minutes.
“The problem today is there’s nothing objective to measure traumatic brain injuries except a CT scan in the hospital,” Eric Goorno, president and CEO of BioDirection, told the Boston Herald. “You sit around waiting for hours. It’s an enormous waste of a hospital system.”
The Tbit is the latest in a line of mHealth and telemedicine devices designed to help healthcare providers detect and begin treatment on brain injuries as soon as possible after a traumatic hit to the head. These devices would prove especially useful at sporting events, in schools and assisted living facilities, with mobile health units at disasters, with the military and even in emergency departments.
“The football field is the one place you think of where there’s the most acute need, but it’s just the tip of the iceberg,” Goorno told the Herald. “Forty percent of the market is slips and falls.”
Goormo said researchers recently completed a trial involving about 100 people and will next move on to a more controlled 500-patient study, which would require federal oversight and continue the process toward U.S. Food and Drug Administration approval. Roughly one year ago the company filed its pre-submission package with the FDA.
Among the many mHealth solutions being tested are apps that help doctors measure a patient’s visual and mental acuity following a concussive hit, as well as online platforms that can measure a patient’s social media habits – even telephone conversations – to detect emotional changes that may indicate brain injury. Those same apps and mHealth platforms can also be used to help providers treat people recovering from concussions.
Along the hardware front, providers are looking at tablet-based program and even robots to deliver concussion-testing solutions in the field, whether that’s on the sidelines of a football game, at a remote trauma center set up after a tornado or near a battlefield. Others are looking to encapsulate those services in a wearable, include virtual reality glasses.