US regulatory authorities have allowed the marketing of a brain wave test, which can diagnose attention-deficit/hyperactivity disorder (ADHD) in children and adolescents aged between six and 17 years.
This device, called Neuropsychiatric EEG-Based Assessment Aid (NEBA), can be used as part of a full medical and psychological examination and helps in confirming an ADHD diagnosis or supporting a clinician’s decision if further diagnostic testing is required when medical or behavioral conditions produce symptoms similar to ADHD.
This system has been manufactured by Georgia-based NEBA Health.
Considered to be one of the most common neurobehavioral disorders in childhood, the ADHD cases are on the rise in the US.
According to the American Psychiatric Association, 9% of adolescents suffer with this condition and the average age of diagnosis is seven years old.
Usually children with ADHD condition have difficulties in paying attention and are hyperactive, impulsive and suffer from behavioral problems.
Based on electroencephalogram (EEG) technology, NEBA system records several types of electrical impulses or waves sent by nerve cells in the brain and the number of times these the impulses are sent off in each second.
A 15- to 20-minute test, it is non-invasive and calculates the ratio of two standard brain wave frequencies, known as theta and beta waves.
In children and adolescents with ADHD, the theta/beta ratio has been found to be higher.
FDA’s Center for Devices and Radiological Health’s Office of Device Evaluation director Christy Foreman said 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 added.
The NEBA System was reviewed by the FDA through the de novo classification process.