A new, non-invasive clinical test for attention deficit hyperactivity disorder (ADHD) in children and adolescents has drawn varying degrees of concern, interest and skepticism from mental health professionals in New England. The test, which takes about 15-20 minutes, was developed by NEBA Health in Augusta, Ga. It uses EEG technology to measure the ratio of theta and beta brain waves.
The testing device, Neuropsychiatric EEG-Based Assessment Aid (NEBA) System, was approved by the FDA on July 15. Several controversial issues surround the NEBA system, not the least of which is the single study – unavailable to the public and conducted by the manufacturer – that was used for FDA approval. Other concerns involve the accuracy, application and cost of this type of assessment.
“I am cautious about the apparent fact that only one research study was done to establish this claim and it was conducted by the creators of the system,” says Mark Reck, Psy.D., senior staff psychologist at the University of Vermont Counseling & Psychiatry Services. “I am also open to the possibility that this may be a potentially useful assessment tool to add to a larger diagnostic assessment system.”
In its study, NEBA Health compared assessments of 275 children made by clinicians and an independent group of ADHD experts. The results, issued in a NEBA Health press release, revealed a 61 percent agreement between individual clinicians and a multidisciplinary team. When clinicians used the NEBA system, the rate improved to 88 percent.
Some experts remain skeptical, however. Thomas E. Brown, Ph.D., associate director of the Yale Clinic for Attention and Related Disorders, feels that the NEBA test can have a negative effect on ADHD diagnoses. One week after the FDA approval, he sent a strongly-worded open letter to Margaret Hamburg, FDA Commissioner, stating that the agency’s action “has created significant risks” for patients with ADHD.
“In the real world, if you have something that produces data that can be put on a piece of paper within a matter of 15-20 minutes, it tends to be seen as objective data that is somehow more valid than the impression that is derived from a conversation with a patient about how they have been functioning over the past five years,” says Brown.
“You’re taking what is essentially an imaging snapshot of the brain in a given moment. It doesn’t tell you anything about how that person is going to be doing 10 minutes later doing a different task.”
No one, including NEBA Health and the FDA, is claiming that the NEBA system is a stand-alone that can replace a full medical and psychiatric workup. The NEBA test is being represented as a diagnostic aid, to be used in conjunction with other assessments.
“It’s part of the puzzle,” notes Thor Bergersen, M.D., a psychiatrist who founded and currently runs ADHD Boston, a practice that focuses on ADHD. “It has been shown definitively that the ratio in patients with ADHD is different than those without ADHD. But there’s no line of demarcation that says this is an ADHD brain and this is not.
“If it helps to make a more accurate diagnosis of ADHD, along with clinical history and other testing, I think it’s worthwhile.”
Some believe that the NEBA exam adds little to the diagnosis but cost, which NEBA Health estimates at $325 per test. The testing equipment rents for $79 a month. And even if used successfully as a diagnostic aid, it’s not clear whether the new test provides useful information for subsequent treatment.
“Everybody is looking for a quick way to do something that is going to look objective,” says Brown. “It doesn’t make a lot of sense.”
By Howard Newman