The US Food and Drug Administration (FDA) has recently approved the first brain-wave test to help diagnose attention-deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years, the agency announced.

The device, called Neuropsychiatric EEG-Based Assessment Aid (NEBA) System, is a  noninvasive test, based on electroencephalogram (EEG) technology. The system computes the ratio of theta and beta brain waves in 15 to 20 minutes, which can be used to help diagnose/or reverse diagnose ADD/ADHD in children and adolescents. Children and adolescents with ADHD have a higher theta-beta ratio than those who do not have the disorder.

Together with a complete medical and psychological workup, the NEBA System can help confirm a diagnosis of ADHD or a decision to focus further testing on ADHD or other conditions with similar symptoms, according to the FDA.

“The NEBA System along with other clinical information may help healthcare providers more accurately determine if ADHD is the cause of a behavioral problem,” 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 agency based its decision to approve the NEBA System in part on a clinical study of 275 children and adolescents with attention or behavioral issues. Clinicians evaluated all of them using the new brain-wave test along with standard diagnostic protocols and physical exams. An independent panel of ADHD experts reviewed the findings to determine whether each patient satisfied the criteria for ADHD or another condition. The study showed that adding the brain-wave test to a clinical assessment helped clinicians make a more accurate ADHD diagnosis than if they had performed only the clinical assessment.

The NEBA System is made by NEBA Health, in Augusta, Georgia.

The NEBA System is now available at South Shore Neuropsychiatric Center in Hewlett, NY. Under the supervision of Medical Director, Edward Fruitman, MD, children and adolescents can be tested and the risk of ADD/ADHD misdiagnosis will be decreased exponentially. For more information call the office of Dr. Edward Fruitman (516)295-4867.

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