The FDA has approved marketing of the first brain wave test that can be used to detect ADHD in children and teens.
The first medical device based on brain function, approved for marketing by the U.S. Food and Drugs Administration, will be used to detect attention-deficit/hyperactivity disorder (ADHD) among children and teens aged between 6 and 11 years.
The new device ,NEBA System, records different kinds of electrical impulses (waves) given off by neurons (nerve cells) in the brain.
"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 in a press 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."
A 15 to 20 minutes long, non-invasive test is conducted with the system during which the ratio of two standard brain wave frequencies, known as theta and beta waves are calculated.
To check the efficacy of the system, manufacturers conducted a study on 275 children and adolescents ranging from 6 to 17 years old with attention or behavioral concerns using the new test. A group of ADHD experts then reviewed the submitted data and concluded that the test did meet clinical criteria for ADHD.
ADHD is very common among children and teens. The American Psychiatric Association revealed in a report that 9 percent of American kids and teenagers suffer from this disorder. In most cases, the adolescent is diagnosed with the disorder at the average age of 7 years.