US FDA approves marketing of brain-wave test to assess ADHD in children

16 July 2013 (Last Updated July 16th, 2013 18:30)

The US Food and Drug Administration (FDA) has approved marketing of Neuropsychiatric EEG-Based Assessment Aid (NEBA), a brain-wave test to assess attention deficit hyperactivity disorder (ADHD) in children and adolescents between the ages of six and 17.

The US Food and Drug Administration (FDA) has approved marketing of Neuropsychiatric EEG-Based Assessment Aid (NEBA), a brain-wave test to assess attention deficit hyperactivity disorder (ADHD) in children and adolescents between the ages of six and 17.

The system is a 15 to 20 minute non-invasive test that can be used as part of a full medical and psychological examination, which will help doctors to identify the cause of ADHD and proceed for further diagnostic testing.

Based on electroencephalogram (EEG) technology, the NEBA System, which is manufactured by Georgia-based NEBA Health, records several types of electrical impulses or waves released by neurons in the brain and the frequency of these impulses for each second.

The test also calculates the ratio of the two standard brain-wave frequencies called theta and beta waves.

Children and teens suffering with ADHD condition have been found to have higher rate of the theta/beta ratio.

FDA Center for Devices and Radiological Health's Office of Device Evaluation director Christy Foreman said that diagnosing ADHD is a multistep process based on a complete medical and psychiatric exam.

"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," Foreman said.

The US regulatory agency reviewed the NEBA System through the de novo classification process, a regulatory method for certain medical devices with low to moderate-risk and are not equivalent to an available device in the market.

FDA approval was based on a clinical trial that studied 275 children and adolescents with attention or behavioural concerns in the six to 17 years age range.

The enrolled patients were examined using the NEBA System and standard diagnostic protocols, and through behavioural questionnaires, behavioral and IQ testing, and physical exams in order to identify the existence of ADHD in them.

The trial results showed that the usage of NEBA System helped clinicians in making a more accurate diagnosis of ADHD, compared with the regular clinical tests alone.

According to the American Psychiatric Association, around 9% of adolescents in the US have ADHD with an average diagnosis age of seven.