US regulators have cleared the first test that uses brain waves to support the diagnosis of attention deficit hyperactivity disorder (ADHD) in children.
The FDA gave permission to NEBA Health to market its NEBA System as part of a wider psychological examination to assess children aged 6 to 17 to help confirm an ADHD diagnosis or a clinician’s decision that further diagnostic testing should focus on ADHD or another condition that produces symptoms similar to the disorder.
ADHD is thought to affect 9 per cent of adolescents in the US, while current diagnosis of the condition involves the recognition by a healthcare professional of symptoms, such as inattention and hyperactivity, and then classifying these into a subtype using approved diagnostic criteria, tools and assessment scales.
Using this method it can take more than two years to reach an ADHD diagnosis in children, while it often takes interaction with three or more doctors before a definitive conclusion can be reached.
Part of the reason for this delay in diagnosis is the possibility of co-existing disorders, with more than 85 per cent of ADHD patients thought to have at least one other behavioural or psychiatric condition.
The NEBA System aims to support this process by measuring the frequency of two types of electrical impulse, known as theta and beta waves, which are transmitted by neurons in the brain.
According to the FDA, the frequency of the theta and beta waves has been shown to be higher in children and adolescents with ADHD than in children without it, and thereby the NEBA system can help filter those children whose symptoms are more likely to be ADHD or another behavioural disorder.
This is based on a study involving 275 children, all of whom were tested with the NEBA System alongside standard diagnostics tools, such as questionnaires.
This data was reviewed by an independent group of ADHD experts, which determined that the NEBA System aided clinicians in making a more accurate diagnosis of ADHD when used in conjunction with a clinical assessment for ADHD.
“Diagnosing ADHD is a multi-step process based on a complete medical and psychiatric exam,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health.
“The NEBA System along with other clinical information may help health care providers more accurately determine if ADHD is the cause of a behavioural problem.”