A new test of brain waves measured by electroencephalogram (EEG) has been approved for helping to diagnose whether a child has attention deficit hyperactivity disorder (ADHD).
The US Food and Drug Administration (FDA) today gave the green light to the NEBA System, which, “along with other clinical information, may help healthcare providers more accurately determine if ADHD is the cause of a behavioral problem,” says Christy Foreman, a product evaluation director at the FDA.
EEGs record electrical impulses, or waves, produced by neurons – nerve cells – in the brain. The technique measures the frequency of the impulses each second. The maker of the system, NEBA Health – based in Augusta, Georgia – submitted research to the FDA showing that the device improved the accuracy of clinicians’ ADHD diagnoses.
NEBA Health did a clinical study of 275 children and adolescents. All 275 patients aged between 6 and 17 years underwent diagnosis using the NEBA System and standard diagnostic protocols, including:
- 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.
An independent group of ADHD experts reviewed the results of the investigations and gave a consensus diagnosis on each child or adolescent to decide whether their problems were due to ADHD or another condition. The FDA says that, compared with doing the standard clinical assessment alone, the clinical trial proved that the addition of the EEG-based test improved the diagnostic accuracy of the ADHD clinicians.
The new, non-invasive test takes between 15 and 20 minutes and “calculates 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 the condition, the FDA says.
Not all researchers and doctors in the ADHD field are behind the idea of using the NEBA test.
William Pelham, director of the Center for Children and Families at Florida International University, told the New York Times he was skeptical. Pelham’s view is that brain research is adding little to the accuracy of traditional methods of diagnosis for children with the disorder. “What’s the point?” he said to the newspaper: “We’re not going to run out and buy one of these machines to do diagnoses, because it is totally unnecessary.”
The American Psychiatric Association says the prevalence of ADHD in the US is 4.1% of all adults (with 1.7% having severe ADHD) and 9% of adolescents (1.8% severe). The average age of diagnosis is 7 years, according to the the stats.
Written by Markus MacGill