FDA permits marketing of first brain wave test to help assess children and teens for ADHD

FDA NEWS RELEASE 

For Immediate Release: July 15, 2013

FDA permits marketing of first brain wave test to help assess children and teens for ADHD

The U.S. Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old. When used as part of a complete medical and psychological examination, the device can help confirm an ADHD diagnosis or a clinician’s decision that further diagnostic testing should focus on ADHD or other medical or behavioral conditions that produce symptoms similar to ADHD.

The device, the Neuropsychiatric EEG-Based Assessment Aid (NEBA) System, is based on electroencephalogram (EEG) technology, which records different kinds of electrical impulses (waves) given off by neurons (nerve cells) in the brain and the number of times (frequency) the impulses are given off each second. 

The NEBA System is a 15- to 20-minute non-invasive test that calculates the ratio of two standard brain wave frequencies, known as theta and beta waves. The theta/beta ratio has been shown to be higher in children and adolescents with ADHD than in children without it.

“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. “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 one of the most common neurobehavioral disorders in childhood. According to the American Psychiatric Association, 9 percent of U.S. adolescents have ADHD and the average age of diagnosis is 7 years old. Children with ADHD have difficulty with attention, hyperactivity, impulsivity and behavioral problems.

The FDA reviewed the NEBA System through the 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.

In support of the de novo petition, the manufacturer submitted data including a clinical study that evaluated 275 children and adolescents ranging from 6 to 17 years old with attention or behavioral concerns. Clinicians evaluated all 275 patients using the NEBA System and using standard diagnostic protocols, including the Diagnostic and Statistical Manual of Mental Disorders IV Text Revision(DSM-IV-TR) criteria, behavioral questionnaires, behavioral and IQ testing, and physical exams to determine if the patient had ADHD. An independent group of ADHD experts reviewed these data and arrived at a consensus diagnosis regarding whether the research subject met clinical criteria for ADHD or another condition. The study results showed that the use of the NEBA System aided clinicians in making a more accurate diagnosis of ADHD when used in conjunction with a clinical assessment for ADHD, compared with doing the clinical assessment alone.

Evaluation of neurofeedback in ADHD: The long and winding road

Biological Psychology 95 (2014) 1–3

Martijn Arnsa,b,∗, Hartmut Heinrichc,d, Ute Strehle

a Research Institute Brainclinics, Nijmegen, The Netherlands
b Utrecht University, Dept. Experimental Psychology, Utrecht, The Netherlands
c Dept. of Child and Adolescent Mental Health, University Hospital of Erlangen, Erlangen, Germany d Heckscher-Klinikum, d München, Germany
e University of Tuebingen, Tuebingen, Germany

abstract

Among the clinical applications of neurofeedback, most research has been conducted in ADHD. As an introduction a short overview of the general history of neurofeedback will be given, while the main part of the paper deals with a review of the current state of neurofeedback in ADHD. A meta-analysis on neurofeedback from 2009 found large effect sizes for inattention and impulsivity and medium effects sizes for hyperactivity. Since 2009 several new studies, including 4 placebo-controlled studies, have been published. These latest studies are reviewed and discussed in more detail. The review focuses on studies employing (1) semi-active, (2) active, and (3) placebo-control groups. The assessment of speci- ficity of neurofeedback treatment in ADHD is discussed and it is concluded that standard protocols such as theta/beta, SMR and slow cortical potentials neurofeedback are well investigated and have demon- strated specificity. The paper ends with an outlook on future questions and tasks. It is concluded that future controlled clinical trials should, in a next step, focus on such known protocols, and be designed along the lines of learning theory.

Attention-Deficit/Hyperactivity Disorder (ADHD) has become one of the most common neurodevelopmental and psychiatric dis- orders of childhood. The general rate of prevalence is reported between 3% and 7% of school age children (Cormier, 2008). In 40–60% of all cases ADHD persists into adolescence and adult- hood (Faraone, Biederman, & Mick, 2006). Currently, the disorder is primarily diagnosed by referring to the criteria of the Diagnos- tic and Statistical Manual of Mental Disorders (DSM-IV) or the International Statistical Classification of Mental Disorders (ICD- 10). According to the DSM-IV, the disorder presents itself in three primary subtypes: predominantly inattentive type, predominantly hyperactive-impulsive type and the combined type. Therefore the core symptoms of ADHD consist of inattention, impulsivity and hyperactivity.

Currently, both stimulant medication and behaviour ther- apy are the most often applied and accepted treatments for ADHD. However, recent large-scale studies and meta-analyses have demonstrated limitations of these treatments. For example, limited long-term effects of stimulant medication (possibly the result of an up-regulation of the Dopamine Transporter (DAT) (Wang et al., 2013)) and behaviour therapy have been reported (Molina et al.)