On July 15, 2013 the FDA
approved the marketing of the first device to be used in the diagnosis of
ADHD. The NEBA (Neuropsychiatric EEG-Based
Assessment Aid) system is based on the observation that on average, people with
ADHD have different brain waves than people who do not have ADHD. Approval of the device is potentially historic on several levels.
Before the approval of NEBA, no objective test has ever been
approved for the diagnosis of ADHD. For
generations, ADHD has been diagnosed using a combination of a doctor's
evaluation and parent and teacher rating questionnaires. The accuracy of the diagnosis is highly subjective: dependent on the evaluating doctor, the
parents, and the teachers providing the information. Traditional diagnosis based only on clinician
evaluation and review of parent and teacher questionnaire has been shown to be
somewhat unreliable as compared to expert evaluation. The addition of the NEBA system to the
diagnostic procedure may improve accuracy in the diagnosis of ADHD for primary
care doctors and other clinicians who are not experts in pediatric ADHD.
If NEBA is really as
good as it seems, then a few important consequences could be forseen.
1) Diagnosis of ADHD will become more objective,
legitimizing the diagnosis and freeing it from accusations that it is a
behavioral problem only, caused by poor parenting, or by the might of the
psychopharmaceutical industry.
2) People who are looking for prescription medication
for ADHD for other reasons, like addiction or drug dealing, will be easier to
weed out, hopefully stemming the growing tide of overdoses and prescription
drug addiction.
There are several
problems, however, with NEBA, that make it less than ideal.
First, the numbers
presented in the trial which convinced the FDA to allow the device to be
marketed show elevated diagnostic accuracy when compared to other
trials using EEG for diagnosis of ADHD in children. The company making the NEBA system has not
had verification of its numbers by researchers who are not also stockholders of
their company.
Second, the brain wave
changes noted on average in the ADHD population are just averages. A large proportion of people--16% in one
study--with ADHD by current diagnostic criteria do not have the brain wave
changes detected by NEBA. A doctor certainly couldn't deny a prescription based
on those numbers, but he or she might ask for more evaluation.
Third, while its
reassuring that the NEBA provides an objective number, the fact is that it
doesn't really add anything to a properly done expert evaluation. The NEBA can only partially replace an expert
evaluation, since in some
studies, more than 60% of children presenting with symptoms of ADHD have
more than one diagnosis, including autism, anxiety, depression, and
oppositional defiant disorder. NEBA
cannot diagnoses any of those. In the
face of ballooning numbers of ADHD diagnoses, the country is in need of more
experts, not necessarily more devices.
Reference:
Loo, Sandra K., and Scott Makeig.
"Clinical Utility of EEG in Attention-deficit/hyperactivity Disorder: A
Research Update." Neurotherapeutics 9.3 (2012): 569-87. Print.
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