In July 2013, the U.S. Food and Drug Administration (FDA) began allowing the marketing of the first brain function medical device to help assess attention-deficit hyperactivity disorder in children and teens between the ages of 6 and 17. According to the FDA, this devicecalled the Neuropsychiatric EEG-based Assessment Aid (NEBA) systemmay be used as part of a complete medical/psychological examination to confirm a diagnosis of ADHD or determine if further diagnostic tests are necessary.
The NEBA system is a non-invasive test that is based on EEG (electroencephalogram) technology. In EEG, different types of electrical impulses (brain waves) given off by nerve cells (neurons) and the number of these impulses per second are measured and recorded. The 15- to 20-minute test determines the ratio of theta and beta waves, which has been shown to be higher in kids and adolescents with ADHD than those without the neurobehavioral disorder.
Studies show that using the NEBA system along with a clinical assessment allowed health care providers to make a more accurate diagnosis of ADHD than clinical assessment alone. The system was reviewed through the FDA's "De Novo" classification process. This process applies to low- and moderate-risk medical devices that are not equivalent to any other approved devices.
The NEBA system should only be used by a qualified health care provider who has experience diagnosing ADHD. It should not be used as a "stand alone" diagnostic test or in children or teens who:
- Have a history of EEG abnormalities
- Have a history of a seizure disorder
- Are taking anticonvulsant medications(s)
- Have a metal plate or device implanted in the head
- Are unable to remain still for at least 30 seconds
The NEBA system is considered safe. Adverse effects associated with undergoing neuropsychiatric EEG-based assessment include misdiagnosis and risks associated with the necessary discontinuation of medicine prior to the procedure in order to obtain an accurate EEG reading.