FDA Approves Brain Wave Test For ADHD In Children & Teens; Theta/Beta Ratio Exam Could Guide The Future Of ADHD Diagnosis

ADHD
The US Food and Drug Administration has approved a new brain wave test that can effectively diagnose ADHD through nerve cells in an adolescent's brain. Center for Disease Control and

A cutting-edge medical device that could change the way children are diagnosed with attention deficit hyperactivity disorder (ADHD) has just received approval from the U.S. Food and Drug Administration (FDA). The Neuropsychiatric EEG-Based Assessment Aid (NEBA) System analyzes a child's brain waves, probing for any signs of attention or behavioral abnormalities.

"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. 

According to the American Psychiatric Association, around nine percent of adolescents in the United States are diagnosed with ADHD, making it the most common neurobehavioral disorder in childhood. Children are likely to be diagnosed at the average age of seven after showing difficulty with attention, hyperactivity, impulsivity, and behavioral problems.

"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," Foreman added.

Developed by NEBA Health in Augusta, Ga., the NEBA System is controlled by electroencephalogram (EEG) technology that records the type of electrical impulses produced by nerve endings in the brain and how many are given off each second.

During the 15 to 20 minutes it takes for the device the conduct its test, the NEBA System records the ratio of two standard brain frequencies, also referred to as theta and beta waves. The number of theta and beta waves in children with ADHD is perceivably higher than those in children without the disorder.

Researchers from NEBA Health conducted clinical studies to determine the effectiveness of this device, compared to standard diagnostic protocols outlined in the Diagnostic and Statistical Manual of Mental Disorders IV Text Revision (DSM-IV-TR) criteria and other methods for detecting ADHD in adolescents.

A total of 275 patients, between the ages of six and 17, who had showed previous signs of attention or behavioral problems were enrolled in the study. Each participant was evaluated using a range of diagnostic methods including the NEBA System. An independent group of ADHD experts was also on hand to review the findings.

Results of the analysis showed that a clinical assessment on its own was not as effective as an assessment coupled with the use of the NEBA System. The device was given full approval following the FDA's de novo classification process, "a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device."

According to the Centers for Disease Control and Prevention, the rate of parent-reported ADHD among children between the ages of four and 17 has escalated in recent years. In 2007, 5.4 million children were diagnosed with ADHD, one million more than those diagnosed in 2003.

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