-- Robert Preidt
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
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,
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
"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
The U.S. National Institute of Mental Health has more about
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