By Wendy Lalli, Marketing Director, Mind Source Solutions
This summer it was announced that the U.S. Food and Drug Administration would allow the marketing of the Neoropsychiatric EED-Based Assessment Aid (NEBA) – a medical device which helps assess whether or not children have attention-deficit/hyperactivity disorder (ADHD) based on their brain function.
According to the press release put out by the FDA, “The NEBA System is a 15-to-20 minute non-invasive test that calculates the ratio of two standard brain wave frequencies, know as the theta and beta waves. The theta/beta ratio has been show to be higher in children and adolescents with ADHD than in children without it.”
What’s the big deal? Not much really for those who already believe in neurofeedback as an effective therapy for ADHD. But it’s a big step forward in terms of having neurofeedback recognized as a legitimate treatment option for ADHD by the educational, mental health, medical and insurance communities.
The FDA’s approval was based on a review of the NEBA system through the de novo classification process, which allows some low- to moderate-risk medical devices to be considered even when there are no similiar devices to it already in the market.
To support it’s petition for approval, NEBA’s manufacturer, NEBA Health in Atlanta, Georgia, submitted data from a clinical study involving the evaluation of 275 patients who used NEBA, along with more standard protocols, to determine who had ADHD and who didn’t. Then an independent group of experts in ADHD reviewed this data and determined a consensus diagnosis as to whether or not the test subjects met clinical criteria for ADHD. They declared that using the NEBA system in conjunction with a clinical assessment of ADHD increased the accuracy of diagnosis made through clinical assessment alone.
Between this pronouncement from the FDA, and the National Institute of Mental Health’s new rating for neurofeedback as “probably efficacious” in treating ADHD, the last few months have marked some real victories for those who provide neurofeedback, their patients and their families.