FDA Okays First ADHD Brain Wave Test
The U.S. Food and Drug Administration (FDA) this week approved the marketing of a brain wave test for attention-deficit/hyperactivity disorder in children and teens. The device is the first one to use brain function to assess children 6 to 17 years old for ADHD. The FDA concluded that the test can help confirm an ADHD diagnosis when used as part of a full medical and psychological exam. The approval was based on a clinical study of 275 children with “attention or behavioral concerns.”
The brain wave test is called the Neuropsychiatric EEG-Based Assessment Aid (NEBA) System, developed by NEBA Health company in Augusta, Georgia. The NEBA System test takes 15 to 20 minutes, and is non-invasive. The test is similar to an electroencephalogram (EEG) exam, as it records electrical impulses in the brain. It then calculates the ratio of two brain wave frequencies called theta and beta waves, which has been shown to be higher in children with ADHD.
“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. “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.”
The American Psychiatric Association estimates that 9% of children in the U.S. have ADHD. Common symptoms of the disorder include behavioral problems such as inattention, hyperactivity, and a tendency to be impulsive.