Device is designed for children 6 to 17 as part of a complete psychological examination.
TUESDAY, July 16 (HealthDay News) -- The first brain wave test that could help diagnose children and teens with attention-deficit/hyperactivity disorder (ADHD) has been approved by the U.S. Food and Drug Administration.
The device can be used in patients between the ages of 6 and 17 as part of a complete psychological examination to either help confirm an ADHD diagnosis or bolster a doctor's decision that more testing for ADHD or other disorders is needed, the FDA said in a news release Monday.
Called the NEBA system, the 20-minute noninvasive test uses an electroencephalogram (EEG) to calculate the ratio of two brain wave frequencies, called theta and beta, which studies have shown is higher in children and teens with ADHD.
One expert offered a word of caution about the device.
"For clinicians and researchers interested in ADHD, an objective diagnostic test that is accurate, sensitive and specific has been one of the 'holy grails' which has long been sought," said Dr. Andrew Adesman, chief of developmental & behavioral pediatrics at Steven & Alexandra Cohen Children's Medical Center of New York, in New Hyde Park, N.Y.
However, he added, "it is doubtful that this EEG test newly approved by the FDA will be as accurate and reliable as clinicians and families would ideally want.
"Given concerns among the public and some professionals about the steady increase in the number of children and adolescents being diagnosed with ADHD, it would be wonderful if clinicians had an objective test to assist in the diagnostic process," Adesman said. "Although this new EEG test may prove helpful to clinicians, neither parents nor professionals will be able to rely upon it as a standalone 'litmus test' for whether a child has ADHD."
Adesman also noted that the FDA has approved other "objective" diagnostic tests for ADHD that have not become a common part of diagnosing the disorder, and the fate of the NEBA system remains to be seen.
The device, made by NEBA Health of Augusta, Ga., is already used to assess sleep issues, measure unconsciousness, diagnose side effects from head injuries and monitor the brain during surgery, according to CBS News.
The FDA's approval of the device was based on a company-funded study of 275 children and teens with attention or behavioral problems. The study showed that the test, when used with standard diagnostic criteria, helped doctors more accurately diagnose the disorder when compared to a doctor's exam alone, the agency said in its statement.
"Diagnosing ADHD is a multistep process based on a complete medical and psychiatric exam," Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said in the news release. "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."
ADHD is a common childhood disorder. Nine percent of American teens have ADHD and the average age of diagnosis is 7, according to the American Psychiatric Association. Symptoms of ADHD include inattention, hyperactivity, impulsivity and behavioral problems. Treatments for ADHD include medication, behavioral modifications and therapy.
SOURCES: Andrew Adesman, M.D., chief, developmental & behavioral pediatrics, Steven & Alexandra Cohen Children's Medical Center of New York, New Hyde Park, N.Y.; U.S. Food and Drug Administration, news release, July 15, 2013; CBS News
Copyright © 2013 HealthDay. All rights reserved.
Published: July 2013