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FDA Approves First Brain Wave Test for ADHD

Jul 16, 2013 04:22 PM EDT
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The U.S. Food and Drug Administration (FDA) announced Monday that it has cleared the first brain wave test to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old.

Called the Neuropsychiatric EEG-Based Assessment Aid (NEBA) System, the test uses electroencephalogram (EEG) technology to calculate the ratio of two standard brain wave frequencies, theta and beta, as certain combinations of these waves appear to be more prevalent in children and adolescents with ADHD when compared to those without.

The non-invasive process lasts between 15 to 20 minutes and is not meant, according to the FDA, to stand alone. Rather, the U.S. agency explained in a press release that it should be used only to confirm an ADHD diagnosis in the case that complete medical and psychological examinations indicate that the disorder may be present.

"Diagnosing ADHD is a multistep process based on a complete medical and psychiatric exam," said Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health. "The NEBA System along with other clinical information may help health care providers more accurately determine if ADHD is the cause of a behavioral problem."

As part of the approval process, the manufacturers carried out and submitted the results of a clinical study in which 275 children and adolescents between 6 and 17 years old with attention or behavioral concerns were evaluated using both the NEBA System and standard diagnostic protocols. Afterward, an independent group of ADHD experts reviewed the results and arrived at a consensus diagnosis regarding each patient. All told, the study showed that "the use of the NEBA System aided clinicians in making a more accurate diagnosis of ADHD when used in conjunction with a clinical assessment" for the disorder, compared with the clinical assessments alone.

ADHD is one of the most common neurobehavioral disorders among youth, with an estimated 9.5 percent of those between the ages of 4 and 17 living with the disorder as of 2007, according to the Centers for Disease Control and Prevention (CDC). According to the CDC, ADHD is characterized by daydreaming frequently, forgetting or losing things often, squirming or fidgeting excessively, talking more than is appropriate, struggling to take turns and generally exhibiting difficulty getting along with others.

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