New brain wave test diagnoses ADHD
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).
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.
To get weekly clinical advice for today's pediatrician, subscribe to the Contemporary Pediatrics eConsult.
Exome sequencing should be used for diagnosing cerebral palsy
October 13th 2023A systematic review and meta-analysis found that such sequencing indeed has an equivalent high genetic diagnostic yield in cerebral palsy, which supports including this neurodevelopmental disorder among those for which diagnostic exome sequencing should be used.
Associations between prenatal metal mixture exposure and negative infant outcomes
September 19th 2023Francheska M. Merced-Nieves, PhD, Assistant professor, Departments of Pediatrics and the Institute for Exposomic Research of Environmental Medicine & Public Health, Icahn School of Medicine at Mount Sinai, explains the associations prenatal exposure to a metal mixture and the potential negative effects for the infant.
