A wiry weave of brainwave-reading electrodes designed to detect signs of attention deficit hyperactivity disorder is drawing skepticism from experts who say behavior trumps brain activity when diagnosing ADHD.
The device, dubbed NEBA for "Neuropsychiatric EEG-Based Assessment Aid," was approved by the U.S. Food and Drug Administration Monday to help confirm an ADHD diagnosis, a complex label borne by some 6.4 million U.S. kids. But critics say the gadget puts profits before patients.
"I don't know that this is going to help the situation at all," said Rachel Klein, a professor of child and adolescent psychiatry at NYU Langone Medical Center. "I think it's going to make people spend money needlessly."
During a 15-minute test, the NEBA system measures and compares two kinds of brainwaves through electrodes on the scalp. Studies have found that kids with ADHD tend to have different brainwave ratios than those without the disorder, but Klein said there's "nothing to suggest" the comparison works to diagnose individual children.
"When a child walks into the office, we already know there's a problem. The issue is whether it's ADHD or something else," she said, noting that learning disabilities and certain mood disorders can share symptoms with ADHD. "We have no idea whether [the makers of NEBA] have been able to discriminate ADHD from something else."
NEBA Health, the Augusta, Ga., company that makes the device, has yet to publicly release data from a trial of 275 children on which the FDA based its approval.
"The study results 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 ADHD, compared with doing the clinical assessment alone," the FDA said in a statement, providing no further details about the comparison or the significance of the results.
Multiple calls to NEBA Health were not immediately returned.
An ADHD diagnosis is typically based on interviews with parents and teachers, though Klein admits not all general practitioners have time to take such a thorough history.
"There's no way someone can do the child justice in a 10- or 20-minute visit," she said, stressing that the diagnosis should be reserved for child psychiatrists and psychologists with the proper training. "You need a lot of background information, and you just don't have the time to get it in a regular medical practice."
Klein fears that busy GPs might buy into the NEBA system, which generates a readout of brainwave activity similar to the squiggly lines of a lie detector test, as a way to simplify a complex diagnosis.
"They can charge for it and it gives you a pseudo-scientific basis for the diagnosis – a piece of paper with little wiggles and you can say they're not the wiggles you expect," she said, adding that she hopes parents "understand the limitations of the test" and "realize they don't have to rely on commercial promotions."
The cost of the NEBA system and the proposed charge for the test has not been made public.
ADHD diagnoses are on the rise among U.S. children and teens, climbing steadily by 5 percent a year, according to data from the U.S. Centers for Disease Control and Prevention. In 2007, roughly 2.7 million U.S. kids were receiving medication for the disorder, according to a CDC survey of parents.
Some experts worry that the disorder is being over-diagnosed and over-treated, but it's unclear whether NEBA would cut down on false positives.
"You could argue that if you required this as part of the diagnosis you would lower the rate of ADHD because many children don't have this [brainwave] abnormality," Klein said. "Whether you would be doing them a service is something I don't know."
Dr. William Graf, a professor of pediatric neurology at Yale School of Medicine in New Haven, Conn., said brainwave measurements are useful in diagnosing neurological diseases like epilepsy. But he stressed that ADHD is a complex behavioral disorder, and its diagnosis is never black and white.
"The 'D' in ADHD stands for disorder, meaning it's believed to cause a functional impairment," he said, adding that he believes "many" child neurologists are skeptical of the device.
"A 15-minute test that measures brainwaves doesn't tell you anything about how a person is functioning in daily life."