FDA approves first EEG test for diagnosing ADHD
A new device approved by the Food and Drug Administration (FDA) will read children and adolescent’s brain waves in order to test for attention deficit hyperactivity disorder (ADHD). The 15 to 20 minute test uses a device called the Neuropsychiatric EEG-Based Assessment Aid (NEBA) System. The NEBA system measures the ratio of certain brain waves that are higher in children with ADHD than other children without this disorder.
The NEBA system is based on electroencephalogram (EEG) technology, which records different kinds of electrical impulses given off by neurons in the brain and the number of times (frequency) the impulses are given off each second.
The process doesn’t take more than 15 to 20 minute, and it’s a totally noninvasive test that calculates the ratio of two standard brain wave frequencies, known as theta and beta waves. The theta/beta ratio has been shown to be higher in children and adolescents with ADHD than in children without it.
“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. “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.”
ADHD is one of the most common neurobehavioral disorders in childhood. According to the American Psychiatric Association, 9 percent of U.S. adolescents have ADHD and the average age of diagnosis is 7 years old. Children with ADHD have difficulty with attention, hyperactivity, impulsivity and behavioral problems.
The FDA reviewed the NEBA System through the de novo classification process, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.
In support of the de novo petition, the manufacturer submitted data including a clinical study that evaluated 275 children and adolescents ranging from 6 to 17 years old with attention or behavioral concerns. An independent group of ADHD experts reviewed the method and arrived at a consensus diagnosis regarding whether the research subject met clinical criteria for ADHD or another condition. The study results showed that the use of the NEBA System aided clinicians in making a more accurate diagnosis of ADHD when used in conjunction with a clinical assessment for ADHD, compared with doing the clinical assessment alone.