Authorities at the U.S. Food and Drug Administration gave the green signal to a medical device that can accurately diagnose attention-deficit/hyperactivity disorder (ADHD) in children, through assessment of brain waves.
The Neuropsychiatric EEG-Based Assessment Aid (NEBA) System is the first scan in the country to get the agencies' approval for ADHD diagnosis in children aged six to 17.
ADHD is a neurobehavioral disorder, symptoms of which start appearing before age seven. ADHD affected children have trouble paying attention, find it difficult to control impulsive behavior (acting without thinking about the consequences), and are prone to hyper-activity.
The device uses electroencephalogram (EEG) technology to identity different types of electrical waves originating from the nerve cells in the brain. These waves are then measured and their frequency is recorded. For determining ADHD in children, the device particularly tracks status of two brain waves known as theta and beta and measures their frequencies. Children with ADHD will have higher ratio of both theta and beta waves. The test that is completely non-invasive takes only 15 to 20 minutes, to analyze results.
"Diagnosing ADHD is a multistep process based on a complete medical and psychiatric exam," Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said in a news release. "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 current approval comes on the grounds of a study conducted by NEBA Health of Augusta, a Georgia-based company, on 275 children and teens aged six to 17. All the participants had attention or behavioral problems. During the study, the children underwent both traditional tests (tests that measured their IQ and behavior; filled questionnaires related to their behavior; underwent tests on physical examination) and the NEBA system, to diagnose ADHD.
Researchers found that the NEBA system when used along with the ADHD clinical assessment provided more accurate diagnosis than the solo result from the clinical assessment.
Stimulant medication like Ritalin, combined with counseling is used to treat the disorder. However, the disease cannot be fully cured and sometimes even lasts well into adulthood.
