Mixed Reaction to FDA Approval of ADHD Brain-Wave Test

Deborah Brauser

August 07, 2013

Reactions have been mixed regarding the recent approval by the US Food and Drug Administration (FDA) of the first brain-wave testing system for attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. The new system is based on electroencephalogram (EEG) technology.

As reported by Medscape Medical News, the FDA approved the noninvasive Neuropsychiatric EEG-Based Assessment Aid (NEBA) system in July as a conjunctive tool in diagnosing ADHD in individuals between the ages of 6 and 17 years.

"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 release.

Used along with these important steps, the new system "may help healthcare providers more accurately determine if ADHD is the cause of a behavioral problem," she added.

However, R. Scott Benson, MD, a child and adolescent psychiatrist in Pensacola, Florida, questions whether the new system really is any better than the diagnostic tools already in place — and whether it adds unnecessary costs.

"We live in a very cost-sensitive environment when it comes to healthcare," Dr. Benson, who is also a member of the Council on Communications for the American Psychiatric Association, told Medscape Medical News.

"As doctors, we love science and would love to find a definitive test to tell exactly what condition someone has. But we haven't found that yet, and I don't think this test is going in the right direction," he added.

Nevertheless, Howard Merry, president of the device manufacturer (NEBA Health, LLC), stands by his product.

"While NEBA does cost patients up front, we believe the boost in clinician diagnostic accuracy will ultimately be cost saving," he told Medscape Medical News.

Reliability Unclear?

The NEBA system, the use of which reportedly takes 15 to 20 minutes, calculates ratios of theta and beta brain waves given off each second. Past research has shown that this ratio is significantly higher in individuals with ADHD.

"ADHD is a very heterogeneous disorder. Our goal is to be more specific in defining these heterogeneous categories so that we can improve treatment," Martin J. Drell, MD, president of the American Academy of Child and Adolescent Psychiatry (AACAP), told Medscape Medical News.

Dr. Martin Drell

"Having such a system would be a dream come true, but I don't think we're there yet," said Dr. Drell.

This was echoed in several of the many comments left by clinicians on Medscape Medical News' Web site. Top concerns included cost and reimbursement issues, how sensitive and specific the testing system actually is, and that more research is needed.

On the other hand, some respondents called this a "big step" forward and noted that clinicians have in the past had to rely on parent-reported information or symptoms presented by the patient. Instead, this new system may eventually provide objective data.

"We are approaching the time of diagnosing diseases with tests," as is the case in other branches of medicine, noted one commenter. "Still, it's not clear the percentage of false positives, and the specificity and the reliability of the test," he added.

Dr. Benson added that he was concerned that the approval appeared to be based on just 1 study, which was submitted by NEBA Health.

Study Details

Although full information on the study has not yet been publicly released, the FDA noted that 275 children and adolescents with attention or behavioral problems were evaluated. To determine whether the participants had ADHD, clinicians used the NEBA brain-wave testing system along with criteria from the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), behavioral questionnaires and testing, and physical examinations.

"An independent group of ADHD experts reviewed these data and arrived at a consensus diagnosis regarding whether the research subject met critical criteria for ADHD or another condition," reported the FDA.

Results showed that more accurate diagnoses of ADHD were found when the NEBA system was used along with clinical assessments than when clinical assessments alone were conducted.

A release by NEBA Health added that the "triple-blinded protocol showed only 61% agreement between individual clinicians and a multidisciplinary team." However, that rate improved to 88% once the NEBA system was added.

"Our study supports that a clinician using NEBA as one part of a full ADHD evaluation would be more likely to converge upon diagnostic evaluation results of a multidisciplinary team," said study chair Steve Snyder, MD, vice president of research and development at NEBA Health, in the release.

In addition to helping clinicians assess ADHD as a primary diagnosis, Dr. Snyder said that the system can help in determining whether the symptoms are actually caused by a different condition.

When asked for more details, the company president confirmed to Medscape Medical News that this was the same study listed on the ClinicalTrials.gov Web site that began in 2007 and ended in June 2008 at 13 sites in the United States. Although Lexicor Medical Technology is listed as the sponsor, NEBA Health acquired the assets of Lexicor in 2007.

Partial study results were presented at the 2011 International Congress on ADHD in Berlin, Germany, and at the 2010 Canadian ADHD Resource Alliance conference in Vancouver.

Merry reported that in more than 700 uses during the study and its follow-up, there were no adverse device events.

"EEG is extremely well characterized and is safe," he said, adding that a paper discussing all of the results is in the process of being submitted to peer-reviewed journals.

When asked about costs, Merry reported that the NEBA equipment rents for $79 per month and that they charge patients approximately $325, depending on region.

"We collect our portion and the clinician's portion of NEBA Services. The clinician is providing collection of EEG services, and we are providing digital analysis of EEG. CPT codes exist for both parts, and some third-party payers will reimburse when a correct ICD-9/10 code is applied," he explained.

Debate Continues

Still, Dr. Benson is not yet convinced of the need for the device.

"Standard evaluation tools, including behavior rating scales, have been around for a long time. Those are still the gold standard, and I don't believe this thing adds anything to the evaluation except for cost," he said.

Dr. R. Scott Benson

"The question is: does this really add anything to a good assessment? And it just doesn't look to me like it is. If the case is that puzzling, it's going to evolve over time. There's nothing urgent about getting a diagnosis, and it isn't an emergency room kind of thing," said Dr. Benson.

"Clearly these children have been having problems for quite a while, and in a complicated case, it may take several visits to really understand what's going on. But it's okay to take that time," he said.

He added that a problem in healthcare today is that "rather than adequately reimbursing a physician for taking time to do a good assessment, we want to suggest that there's a test that's going to provide the answer."

"One of the biggest concerns I hear from parents is the idea of having children on medicine. And I don't think this test is going to answer that for them at all. That's only going to come from careful discussions with their physician."

When asked about these issues, Merry answered that the new device "is not trying to take the place of the gold standard." Instead, a clinician should perform a standard assessment prior to using the NEBA system.

"ADHD shares symptoms with many other psychiatric disorders. NEBA can be applied to patients who present with these attention and behavioral problems. After a standard clinical workup, the system can move that clinician's diagnostic output closer to what a multidisciplinary team's would be," he said.

"It's not replacing the gold standard; it's integrating with the gold standard."

Potentially Valuable

When asked for comment, Sandra Sexson, MD, professor of psychiatry and pediatrics and chief and training director of the Division of Child, Adolescent and Family Psychiatry at Georgia Regents University in Augusta, was cautiously optimistic.

"Sometimes parents need the confirming laboratory test when the diagnosis of ADHD is not too clear," Dr. Sexson told Medscape Medical News. However, she noted that in many other cases, the diagnosis is clear and additional testing is not needed.

Still, Dr. Sexson, who also currently chairs the AACAP Work Group on Lifelong Learning, noted that the system could potentially play an important role.

"If the EEG can be used to differentiate ADHD from bipolar disorder, research that can be done now that the technique is approved to diagnose ADHD, such differentiation would be tremendously valuable to the practicing child and adolescent psychiatrist," she said.

"It is fairly frequent that we struggle with that differentiation, particularly in younger youth."

The FDA's letter announcing approval for immediate marketing of the device is available on the organization's Web site.

NEBA Health reports that a Qualifying Therapeutic Discovery Project grant from the NIH/HHS was awarded to the company in 2010. Dr. Sexson reports that her center was involved "in some of the early field studies as one of the testing sites with Lexicor," and her division received some research funding several years ago to serve as a research site. Although NEBA Health is also based in Augusta, Dr. Sexson reports that she has had no recent contact with the company.

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