FDA Approves First Cognitive Screening Test For Head Injury Patients
Federal health regulators in the United States approved on Monday the use of two new computer softwares as cognitive screening tests for traumatic head injury patients.
Known as ImPACT or the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), the new testing device, as well as a similar test designed for children, can be used by doctors to evaluate signs and symptoms of head injuries that could indicate concussion.
ImPACT is designed for patients aged 12 to 59 years old, while ImPACT Pediatric is intended for children aged 5 to 11 years old, officials said. Licensed health care professionals are the only ones allowed to perform the analysis and interpret the results.
The software can be accessed easily because it runs on both desktop computers and laptops, according to the U.S. Food and Drug Administration (FDA). Both tests the first ever devices permitted by the FDA to assess cognitive function after experiencing a possible concussion. They are designed to be part of medical evaluations in hospitals.
Although ImPACT and ImPACT Pediatric will definitely be useful for doctors, both tests are not meant to diagnose concussions or determine treatments that are appropriate for such cases, the FDA said.
Instead, both devices are only designed to test cognitive skills such as reaction time, memory and word recognition. All of these can be impacted by head injuries. Afterwards, the results are compared to a patient's pre-injury baseline scores or an age-matched control database, the FDA said.
Dr. Carlos Peña, director of the neurological and physical medicine division at the Center for Devices and Radiological Health, acknowledges that the two testing devices can provide useful information that can aid doctors in the evaluation of people who are experiencing potential signs of concussion.
However, Peña says that clinicians should not completely depend on the tests alone to rule out concussion or to decide whether a player with a head injury should return to a game.
Statistics from the Centers for Disease Control and Prevention (CDC) reveal that traumatic brain injuries are responsible for more than 2 million visits to the emergency room in the country annually. Traumatic brain injuries also account for more than 50,000 deaths in America every year.
Cases of head injury among kids have been increasing. In May, a CDC report showed that from January 2001 to December 2013, approximately 214,883 children aged 14 years old and below were brought to emergency departments due to head injuries.
Photo: Kai Hendry | Flickr