Study: FDA-cleared biomarker can reduce ADHD overdiagnosis

A new study suggests that integrating a biomarker based on data from an electroencephalogram (EEG) can offer pediatricians a more accurate way to diagnose attention deficit hyperactivity disorder (ADHD) in children, thereby helping to eliminate unnecessary drug therapy.

The trial is of the Neuropsychiatric EEG-Based Assessment Aid (NEBA) System from NEBA Health; the data are published in the latest issue of the journal Brain and Behavior.

The NEBA System is a 15- to 20-minute noninvasive test based on an EEG that records different kinds of electrical impulses given off by neurons in the brain and the number of times the impulses are given off each second.

This is used to calculate the ratio of two standard brain wave frequencies, known as theta and beta waves. The theta/beta ratio has been shown to be higher in children and adolescents with ADHD than in children without it.

ADHD symptoms are similar to and can easily be confused with other indications such as head injury, auditory processing disorder and substance abuse. The standard approach to ensuring an accurate ADHD diagnosis is to require a consensus from an independent, multidisciplinary team consisting of a psychiatrist, a psychologist and a neurodevelopmental pediatrician.

First, the study had a sole clinician evaluate 275 children and adolescents with attention and behavioral concerns. Of these, 209 patients met the ADHD criteria according to one physician. Then they were reviewed by a multidisciplinary team, which found that of these 93 were less likely to meet ADHD diagnostic criteria.

The NEBA test was then applied to those 93 and in 91% of cases, the test agreed that the subject was unlikely to have ADHD. The researchers concluded that the integration of the NEBA test into the diagnostic process could improve ADHD diagnostic accuracy from 61% to 88%.

The FDA approved the NEBA test in July 2013. "Diagnosing ADHD is a multistep process based on a complete medical and psychiatric exam," Christy Foreman, the former director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said at the time. "The NEBA System along with other clinical information may help healthcare providers more accurately determine if ADHD is the cause of a behavioral problem."

At that time, the agency cited a rate of 9% of U.S. adolescents having ADHD with an average age at diagnosis of 7 years old.

"Our multidisciplinary results showed ADHD may be overdiagnosed in the clinic as much as one-third of the time. And, NEBA separately identified most of those cases," Dr. Steven Snyder, head of research at NEBA Health, said in a statement.

"Because underdiagnosis can lead to poor future outcomes in children with ADHD, a lot of effort has gone into developing assessment tests that are sensitive in detecting ADHD-like symptoms," Snyder continued. "NEBA can complement existing tests by helping clinicians to rule out ADHD in the appropriate cases."

- here are the release and the study
- get the research article

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