The FDA has approved a novel medical device that assesses ADHD in children and adolescents by evaluating brain waves, according to a press release from the agency.
“When used as part of a complete medical and psychological examination, the device can help confirm an ADHD diagnosis,” wrote the FDA.
The device is called the Neuropsychiatric EEG-Based Assessment Aid (NEBA) System. Using electroencephalogram (EEG) technology, it is able to record the frequency at which nerve cells in a patient’s brain are giving off different electrical impulses.
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The test is noninvasive and lasts between 15 and 20 minutes.
The device uses the information to determine the ratio of two standard brain wave frequencies, called theta and beta. The test has been used in the past to evaluate patients with sleeping disorders and head injuries, but children with ADHD have been shown to have higher theta/beta ratios than those without the disorder, giving a new clinical function to the system.
Pinpointing ADHD in a patient can be complicated, since much of the evaluation relies on psychological and behavioral analysis. “Diagnosing ADHD is a multistep process,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, reminding doctors that the NEBA system is to be used in conjunction with other examinations.
The press release noted that in a trial study preceding the approval, 275 patients between the ages of six and 17 were evaluated using the NEBA system in addition to the standard clinical assessment, which includes behavioral questionnaires, behavioral and IQ testing, and physical exams. After a group of ADHD experts reviewed the data, it was agreed that the NEBA system can help doctors diagnose ADHD more accurately.
The introduction of a new way to diagnose ADHD is welcome news. ADHD is the most prevalent mental health disorder, according to the CDC, as almost 7% of US children between the ages of 3 and 17 are affected by it. ADHD is characterized by trouble with attention, hyperactivity, impulsivity and behavioral problems.
by Walker Harrison, an undergraduate student at Columbia University and editorial intern with Clinical Advisor.
