FDA-Approved Devices Assess Cognition After Possible Brain Injury in Youth

Two devices for assessing cognitive function immediately following a suspected brain injury or concussion have been approved for marketing by the Food and Drug Administration (FDA).

The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices approved for marketing to assess cognitive function following a possible concussion, according to the FDA. They are intended as part of the medical evaluation that doctors perform to assess signs and symptoms of a head injury.

ImPACT and ImPACT Pediatric test cognitive skills that could be affected by a head injury, such as word memory, reaction time, and word recognition. The results are compared with an age-matched control database or to a patient’s pre-injury baseline scores if available.

APA Director of Research Philip Wang, M.D., Dr.P.H., said the devices appear promising. “I don’t know the specific data that the FDA used to approve this particular set of measures to administer to kids with head trauma, but the literature suggests that after TBI you can see functional impairment on cognitive measures these devices are targeting—reaction time and verbal memory,” he said. “These have been correlated with neuroimaging findings, so in that sense they have been validated. It’s easier to measure cognitive reaction time and verbal memory than put someone in an fMRI.”

Psychiatrists generally are not asked to assess children for cognitive impairment after a sports injury. But Wang said the larger implications for psychiatry of computerized assessment of cognitive impairment are in the early identification of and intervention for mental illness.

He cited the Philadelphia Neurodevelopmental Cohort developed by Ruben Gur, Ph.D., and Racquel Gur, M.D., Ph.D., at the University of Pennsylvania. The Philadelphia Cohort is a research initiative funded by the National Institute of Mental Health that includes a population-based sample of over 9,500 individuals aged 8 to 21 from the greater Philadelphia area who received medical care at the Children’s Hospital of Philadelphia (CHOP) network for a range of conditions.

Subjects were initially enrolled in the genetic study at CHOP’s Center for Applied Genomics, but all cohort participants were also assessed neuropsychiatrically with a structured interview and completed a Computerized Neurocognitive Battery. The latter is a computerized neurocognitive battery that enables quantitative assessment of multiple cognitive domains: executive control, episodic memory, complex cognition, social cognition, and sensorimotor speed.

The project enables researchers to link genetics, neurocognitive development, and brain imaging to chart the development over time of a large population, including healthy individuals and those with a range of psychiatric and other conditions.

In a study published April 4 in Applied Neuropsychology, the Computerized Neurocognitive Battery was used to assess cognition among veterans with PTSD who had experienced blasts from Improvised Explosive Devices in Afghanistan or Iraq. That paper revealed slower processing speed among those veterans who also reported symptoms of traumatic brain injury.

For psychiatry, Wang said that the Gurs’ work is most promising for early identification of children and adolescents at risk for schizophrenia or other serious mental disorders.

“With the Philadelphia cohort, you can see deficits as early as age 8 in areas such as social cognition, verbal learning, and memory,” he said. “Just as you can see deviations when a kid starts to fall off a height and weight chart, you can see the same thing with cognitive development using the Computerized Neurocognitive Battery.”

Without early neurocognitive measures such as are provided by the battery, prevention is almost impossible, Wang said. “Neurocognitive tests administered via computer are probably our most promising route to early detection and prevention,” he said. ■