The first medical device based on brain function has been approved by the FDA to help assess attention-deficit/hyperactivity disorders (ADHD) in children and adolescents 6–17 years of age.
The Neuropsychiatric EEG-Based Assessment Aid (NEBA) System, when used as part of a complete medical and psychological exam, can help confirm an ADHD diagnosis or a clinician’s decision that further testing should focus on ADHD or conditions that produce symptoms similar to ADHD.
The NEBA System is a non-invasive test that calculates the ratio of two standard brain wave frequencies, known as theta and beta waves, in 15–20 minutes. In children and adolescents with ADHD, the theta/beta ratio has been shown to be higher than in children without the condition.
The approval for this test was based on a clinical study that evaluated 275 children and adolescents ranging from 6–17 years old with attention or behavioral concerns. Clinicians evaluated all 275 patients using the NEBA System and using standard diagnostic protocols, including the DSM-IV-TR criteria, behavioral questionnaires, behavioral and IQ testing, and physical exams to determine if the patient had ADHD.
An independent group of ADHD experts reviewed these data and arrived at a consensus diagnosis regarding whether the research subject met clinical criteria for ADHD or another condition. The study results showed that the use of the NEBA System aided clinicians in making a more accurate diagnosis of ADHD when used in conjunction with a clinical assessment for ADHD, compared with doing the clinical assessment alone.
The NEBA System is manufactured by NEBA Health of Augusta, GA.
For more information visit FDA.gov.