ImPACT: A New Device to Treat Traumatic Brain Injury

    16/10/2016

    ImPACT

    A piece of great news came this year for clinicians and scientists working to treat traumatic brain injury. Two novel medical devices were approved by the US Food and Drug Administration at the end of August. They are called the Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric for children. They are essentially computerized tests that assesses cognitive skills of people with suspected concussion or brain injury. ImPACT is a software that can be installed on any computer and used to help with diagnosis and treatment of people ages 12 to 59. ImPACT Pediatric is used to assess the same types of injury in children ages 5 to 11. According to the manufacturer, this is how it works for athletes:

    You do a baseline test before the sports season.The baseline scores are collated and stored in private servers. After a suspected concussion during the season, you report to the healthcare provider and they administer another test to you: word memory, reaction time or word recognition. The results are collected and compared with the baselines. These tests can be administered again during rehabilitation and treatment. The tests should take around 25 minutes and is done online.

    As of now the software can only be used by trained physicians, nurses and people who have undergone specialized ImPACT credential certification courses. This device is not a cure or even meant to be a stand-alone diagnosis. However it will allow health care providers to more quickly diagnose brain injuries to athletes on a field, or to anyone with a brain injury in any situation. The ImPACT website proudly boasts that its product has been sold and tested at thousands of colleges, universities and clinical trials centers and that over 250 peer-reviewed publications have been written about the effectiveness of the device.

    More than two million people visit the hospital with traumatic brain injury every year and this contributes up to 30% of injury related deaths. Usually doctors perform a neurological exam to test cognition, motor functions, sensory functions and reflexes. Patients with more severe life-threatening injuries undergo magnetic resonance imaging (MRI) tests, computerized tomography (CT) scans. Until now there has not been a unifying benchmark test that can be used reliably to test for traumatic brain injury. To me, the introduction of the ImPACT medical device portents two exciting opportunities. One is that, obviously, this device could help save many lives by eliminating the delayed diagnosis of people who suffer severe brain injuries. All those athletes who come off the field from an injury can now look forward to a safer, more precise method of diagnosis to determine whether they can continue playing or not. Secondly, from a regulatory perspective, this is a de novo review pathway for novel, low- to moderate-risk devices and it is a one of a kind invention. That means future medical devices could be approved more quickly through the same pathway.

    For more information go to:

    https://www.impacttest.com/

    FDA Press Release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm517526.htm

    FDA Information on TBI: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm519116.htm

    http://www.fiercebiotech.com/medical-devices/fda-clears-impact-s-computerized-cognitive-tests-for-concussion-assessment