Tuesday, July 16, 2013

FDA Approves Device to Help Diagnose ADHD in Children

The Food and Drug Administration (FDA) approved marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in youth aged 6 to 17. In a statement, the FDA said that when used as part of a complete medical and psychological examination, the device can help confirm an ADHD diagnosis or a clinician’s decision that further diagnostic testing is necessary to assess symptoms similar to ADHD.

The device, the Neuropsychiatric EEG-Based Assessment Aid (NEBA) System, is based on electroencephalogram technology, which records different kinds of electrical impulses given off by neurons in the brain and the number of times the impulses are given off each second. The NEBA System is a 15- to 20-minute noninvasive test that calculates the ratio of two standard brain-wave frequencies, known as theta and beta waves; the ratio has been shown to be higher in children and adolescents with ADHD than in those without it, according to FDA.

“Diagnosing ADHD is a multistep process based on a complete medical and psychiatric exam,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, in a statement. “The NEBA System along with other clinical information may help health care providers more accurately determine if ADHD is the cause of a behavioral problem.”

Child psychiatrist Louis Kraus, M.D., cautioned, however, that the device should never be considered a substitute for a clinical assessment by a physician. "ADHD is a clinical diagnosis and is very clearly defined that way in DSM-5," he told Psychiatric News. "There is no one specific test that can make the diagnosis of ADHD." He said other neuroimaging tools have been proposed as diagnostic of ADHD and have been found to be problematic. "No one should ever look at these tools as overriding the clinical diagnosis," Kraus said. "On the positive side, [the newly approved device] is noninvasive and could be used to support a clinical diagnosis. But ADHD is a disorder involving particular behaviors in the area of attention, hyperactivity, and impulsivity that must occur in more than one environment—at home, at school, or elsewhere. So parents' observations, for instance, will be an important part of an overall clinical assessment."

For more information about recent research on children and ADHD, see Psychiatric News here.

(Image: gwolters/shutterstock.com)