The first brain wave test to diagnose attention-deficit/hyperactivity disorder (ADHD) will be hitting the market following recent approval by the US Food and Drug Administration (FDA).
FDA is permitting marketing of the first ever such medical device that, when used on children aged 6 to 17 years as part of a complete medical and psychological examination, can help confirm a diagnosis of ADHD.
The device is called the Neuropsychiatric EEG-Based Assessment Aid (NEBA) System. Based on electroencephalogram (EEG) technology, the 15- to 20-minute noninvasive test calculates the ratio of theta and beta brain waves. Experts have shown the theta/beta ratio to be higher in children and adolescents with ADHD than in children without it.
The hope is that the system, combined with other clinical information, will help health care providers more accurately determine if ADHD is the cause of behavioral problems.
According to the Centers for Disease Control and Prevention, about 9% of US adolescents have ADHD. The average age of diagnosis is 7 years. Children with ADHD have difficulty paying attention and focusing, and they often exhibit hyperactivity, impulsivity, and behavioral problems. The symptoms are common, somewhat subjective, and shared with many other common disorders, which can make the condition difficult to diagnose conclusively.
The FDA approved the new system through the de novo classification process, a regulatory pathway for low- to moderate-risk medical devices that are substantially different from devices already legally being marketed. Its decision was based largely on a clinical study involving 275 children and adolescents ranging in age from 6 to 17 years with attention or behavioral concerns. The study demonstrated that use of the NEBA System in conjunction with a clinical assessment for ADHD aided clinicians in making a more accurate diagnosis of ADHD, compared with using a clinical assessment alone.
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