Shirah Vollmer MD

The Musings of Dr. Vollmer

NEBA: FDA Approved…..Hmmm…..

Posted by Dr. Vollmer on August 12, 2013

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm360811.htm

 

NEBA, the Neuropsychiatric EEG-Based ADHD Assessment Aid, has been FDA approved by the Center for Devices and Radiological Health, is a prescriptive device to aid in the diagnosis of ADHD. It uses the theta/beta ratio of the EEG for a patient 6-17 years of age, combined with a clinician’s evaluation to aid in the diagnosis of ADHD. The obvious question is how does this add to the clinical evaluation? A thorough history is the key to the diagnosis. Medication trials add new information. It might be interesting to see what the NEBA reports, but beyond interest, I am not clear how this is a useful clinical tool. The history would sway my thinking more than the brain waves, at this point in the science. The biomarkers are still not clear. We are moving towards understanding the brain, which will require less and less history, and more technology, but it seems to me, we are not there yet. Still, it is interesting that the FDA has approved this device, which, to my knowledge, has not been used in any other country. The device is from a start-up company in Augusta, Georgia, headed by Howard Merry. In the era of being able to quantify our bodily functions, it is exciting to think that our brain waves can be measured by a device that looks like a tablet. This excitement generates a wish that we could find objective measurements for diagnoses which, like ADHD, require painstaking history-taking. This wish will stimulate further research and development, so perhaps the NEBA is the important first step. On the other hand, it is important to know when something is more of a wish than a useful tool.

6 Responses to “NEBA: FDA Approved…..Hmmm…..”

  1. Ashana M said

    It sounds like it’s going to be more helpful in understanding and treating a subgroup of ADHD patients with greater executive function deficits than as a diagnostic tool for ADHD generally.

  2. Shelly said

    Why is it useful only in patients 6-17 years of age? Is the beta/theta ratio different in ADHD children than adults? And who decides the range of ADHD ratios, the NEBA manufacturers, neurologists, psychiatrists? CEDR?

    • All very good questions. I think they sought FDA approval for kids ages 6-17, but this is, as you point out, quite arbitrary. The ratio would be the same for adults and kids. The NEBA research group decides the range, although again, that is a very interesting point. Thanks.

      • Dr. Vollmer: We determined 6-17.99 as NEBA’s indications for use for regulatory reasons, mostly. The FDA has stringent requirements for reference standards. When we started our work on the NEBA project in 2004-2005, adult ADHD was less well characterized. Coming up with a reference standard for adults would have been difficult in a regulatory context. Conversely, rating scales and other instruments commonly used in ADHD workups are often validated in the 6-17.99 age range. Hope this helps. Howard Merry, NEBA Health.

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