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FDA approves first brain wave test for diagnosing ADHD

Teresa Tanoos's picture
FDA approves new device to test for ADHD

If you've ever wondered if your child has attention deficit hyperactivity disorder (ADHD), there's now a new test available that measures brain waves by electroencephalogram (EEG) to help diagnose the disorder.

The US Food and Drug Administration (FDA) approved the NEBA System on Tuesday.

"Along with other clinical information, (the NEBA System) may help healthcare providers more accurately determine if ADHD is the cause of a behavioral problem," said Christy Foreman, a product evaluation director at the FDA.

Using EEGs to record electrical impulses produced in the brain by nerve cells in the brain, the device measures the frequency of the impulses, or brain waves, each second.

NEBA Health in Augusta, Georgia, which makes the device, submitted research to the FDA showing that it improved the accuracy of ADHD diagnoses after a clinical study of 275 children and adolescents.

All 275 patients, who were between the ages of 6 and 17 years, were diagnosed using the NEBA System device and standard diagnostic protocols, including the following:

  • Criteria in the psychiatrists' manual, the Diagnostic and Statistical Manual of Mental Disorders IV Text Revision (DSM-IV-TR)
  • Behavioral questionnaires
  • Behavioral and IQ testing
  • Physical examinations.

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Next, an independent group of ADHD experts reviewed the results. They then gave a consensus diagnosis on each child or adolescent to decide whether their problems were due to ADHD or another condition.

According to the FDA, the clinical trial proved that the addition of the EEG-based test improved the diagnostic accuracy of the ADHD clinicians when compared with the standard clinical assessment alone.

The new test is non-invasive test and takes between 15 and 20 minutes to perform and "calculates the ratio of two standard brain wave frequencies, known as theta and beta waves." The FDA says that the "theta and beta" ratio has been found to be higher in children and adolescents with ADHD than in those without the disorder.

Nevertheless, there is disagreement by both researchers and physicians in the field of ADHD disagree as to whether or not the new NEBA test is actually useful.

One such skeptic is William Pelham, director of the Center for Children and Families at Florida International University. From Pelham's perspective, brain research is adding little to the accuracy of traditional methods of diagnosis for children with the disorder. "What's the point?" he told the New York Times. "We're not going to run out and buy one of these machines to do diagnoses, because it is totally unnecessary."

Meanwhile, the prevalence of ADHD is on the rise, not just in children, but in adults. The American Psychiatric Association reports that 4.1 percent of all adults in the U.S. have ADHD, with 1.7 percent of adults having a severe case of it compared with the 9 percent of adolescents with ADHD, of whom 9 percent have severe ADHD.

Although statistics say the average age of diagnosis with ADHD is 7 years, there are many who go undiagnosed until they are in adulthood, which suggests that ADHD is not always a disorder that kids grow out of it, but a condition that may well into adulthood.

SOURCE: U.S. Food and Drug Administration, FDA permits marketing of first brain wave test to help assess children and teens for ADHD, FDA press release (July 15th, 2013)