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Brain wave device for ADHD approved by the FDA

July 17, 2013

If you get ADHD alerts or listen to the media, you may have heard of the FDA approval for a brain wave test to aid in the diagnosis of ADHD. The study involved 275  children between ages 6-17. The test is an EEG and they say that the ratio of specific brain waves (theta and delta) increase the accuracy of making the ADHD diagnosis.

Here are my reservations:

1. The FDA has not released the study data so there is no way for researchers and clinicians to review the merits of the study.

2. Study methodology can strongly influence the data and subsequent interpretation.

3. We don’t know the threshold of benefit that was used by the FDA to merit the approval. The threshold was not indicated in their approval statement.

4. I’m unable to locate the study as a scientific publication at the NIH publication database (www.pubmed.com)

5. What you may be reading in the media is simply a combination of the FDA’s statement of their approval and the press releases by the company who sought the approval.

6. Historically, attempts to find diagnostic tests like this for ADHD have been very elusive and ultimately of little added benefit in clinician practice.

7. Resist the “sales” pitch of practitioners to use and bill for this “test”. The prescribed treatment will still be the same, regardless of the “test” results.

Until the study or studies are publically available for scientific review, please be skeptical.  If it proves to useful, the studies will clearly indicate it.  Until then…..

David W. Goodman, M.D.

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