FDA approves NEBA brain wave test for ADHD

[healthy11]

www.cbsnews.com/8301-204_162-57593832/first-adhd-brain-wave-test-approved-by-fda/

A portion of the article is below:

The Neuropsychiatric EEG-Based Assessment Aid (NEBA) System is the first medical device of its kind to help diagnose the neurobehavioral disorder in children and teens age 6-17. It uses an electroencephalogram (EEG) test to look at the patient's brain waves.

"Diagnosing ADHD is a multistep process based on a complete medical and psychiatric exam," Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said in a written statement. "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."

An EEG records electrical impulses given off by nerve cells. It records the number of times the signals are given off each second.

The test is often administered to evaluate sleep problems, measure unconsciousness, diagnose problems from head injuries and monitor the brain during surgery. Now, it may help diagnose ADHD.

NEBA is an up to 20-minute test that measures the ratio between the theta and beta brain wave frequencies. Previous research has shown the theta/beta wave ratio is higher in children and adolescents with ADHD than those without it. NEBA Health of Augusta, Ga. makes the system.

[empeg1]

We are reading the same info, Healthy. See my post under medication! Empeg

[empeg1]

Large alpha waves are associated with a mental state of "I am awake but not doing much". It is an eye's open and resting state. Beta waves occur with activity and concentration. Theta waves are lower frequency and there amplitude increases with a person is drowsy, inattentive and drifting off to sleep. Delta waves occur during deep sleep. Beta waves also occur during sleep, but only during REM, when the brain is actively processing information/memories. A pattern of increased theta over beta waves is shown with most individuals who have ADHD. Research indicates a high specificity, of at least 94% accuracy, in identifying subjects diagnosed with ADHD vs controls. There is a subset of individuals diagnosed with ADHD who do not show this pattern; as a group, these individuals are reported not to respond well to stimulant medication. The higher ratio of large theta waves over the beta waves make sense if one is thinking of concentration vs inattention.
A higher ratio of theta to beta waves is also connected to other neurological/psychiatric disorders.
BTW, neurofeedback works on changing this ratio.

[bros]

I'm pretty sure my theta waves used to be depressed and my beta waves used to be really really high

[empeg1]

That is a pattern associated with anxiety

[Mayleng]

Very interesting.

[bros]

Jul 17, 2013 1:33:47 GMT -5 empeg1 said:

That is a pattern associated with anxiety

My epilepsy specialist said it was a genetic marker for epilepsy.

Now I just have generalized activity in my brain with localized symptoms

[ceratops]

Interesting. I wonder when (and if) this will show up in clinical practice. Sometimes these research-derived tests seem to leap right into the doctor's office; at other times they hang around on the sidelines for years. As a non-invasive procedure, it seems that an EEG based test might come into general use more quickly, perhaps. And the equipment for EEGs is already commonly available (it's not like sending hundreds of thousands of people off for fMRI scans, for example).

[empeg1]

This procedure is already showing up in medical practice and may help in differential diagnosis when behavioral characteristics can look like ADHS but may indeed be anxiety. For me, I am now wondering what brain scan patterns might show with fetal alcohol spectrum disorders, as differential diagnosis of ADHD vs Fetal Alcohol Spectrum Disorders can be quite difficult. And, about 97% of individuals with FASD are also diagnosed with ADHD.

[bros]

fMRI on FASD individuals would probably be interesting

[SharonF]

Forgive my skepticism.

I'm concerned that the public, teachers and health insurance companies may see this test as 100% accurate and failproof. Or they may see this test as a way to bypass the long process of interviews and behavioral observations that are currently the cornerstone of ADHD diagnoses.

But ADHD is often the opposite: complex and elusive. Especially when ADHD is comorbid with other issues from LDs to anxiety.

I already dislike the DSM's criteria for ADHD because they seem to ignore many of the real issues caused by this disorder. Now we've got a 10-minute brain wave test. So...what if the results of that test are false-positive? False-negative? Mixed? Will insurance deny the diagnosis or deny coverage of ADHD meds if a kid's brain waves don't match the pre-determined ADHD pattern?

What if a kid doesn't really have ADHD but gets a false positive on this test? Will teachers assume that the best answer is ADHD meds--when the real solution is specially-designed instruction as mandated by federal law?

The literature I've read about this test indicates it is to be used IN CONJUNCTION with a full medical evaluation for ADHD. But our world is driven by profits and simplicity. I'm concerned this test might be used instead of a full medical evaluation. Not in conjunction with a full eval.

"I don't know that this is going to help the situation at all," said Rachel Klein, a professor of child and adolescent psychiatry at NYU Langone Medical Center. They can charge for it and it gives you a pseudo-scientific basis for the diagnosis – a piece of paper with little wiggles and you can say they're not the wiggles you expect," she said, adding that she hopes parents "understand the limitations of the test."

I am not opposed to using EEGs. I have epilepsy and have had many EEGs in my life. They are useful tools. But EEGs and other brain wave tests are just that: tools. Measuring electrical impulses in the brain is NOT the same as truly understanding how a person's brain is working.

[healthy11]

Sharon, you bring up valid concerns. The article stated, ""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." but too often people, especially at schools, rely on a single instrument to decide what's wrong. On the other hand, another newer ADHD evaluation tool, the QUOTIENT test, has NOT become the "gold standard" or only way to diagnose, and I doubt if the NEBA system will, either, because neither the QUOTIENT or NEBA seem like they can easily be done by school personnel.
blogs.psychcentral.com/adhd-zoe/2011/01/new-adhd-diagnostic-test-the-quotient-adhd-system%C2%AE/

Here is some Chadd information re: ADHD diagnosis and the use of brain wave technology: www.chaddleadershipblog.blogspot.com/2013/07/a-brain-wave-diagnostic-test-for-adhd.html

Here's what Additude magazine says: www.additudemag.com/adhdblogs/19/10209.html

[eoffg]

FDA News Release:
"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."

Where it was simply approved as a new device to measure beta/theta brain wave ratios.
While they claim that previous research has shown that children and adolescents with ADHD have a higher theta/beta brain wave ratio.
Just released research, contradicts this conclusion.
So that its validity as a test for ADHD is doubtful at best.

But a crucial factor, is that this device is only useful for a prognosis, rather than a diagnosis.
Where beta/theta brain waves are detected as symptoms, without identifying the causation.
Which reflects the fact that any EEG can only detect activity in surface regions of the brain.

[empeg1]

With all due respect, the diagnosis of ADHD already includes using information from more than one source. As the changing criteria of the DSM-V show, what is used at one point in time for diagnosis, may not be used at a different point in time. Besides, if one is questioning the validity of using brain wave analysis as part of diagnostic procedures for ADHD, then how about using the DSM? The latter does not even begin to address the question of validity, as the whole issue of inclusion in the DSM has to due more with reliability-that psychiatrists can agree on what criteria constitute the characteristics that make up a diagnosis. And, what about parent and teacher ratings that are used in the diagnosis of ADHD. What about the validity of those measurements?

There is a large body of literature regarding QEEG and ADHD, dating back more than 30 years. The preponderance of the results indicate a theta/beta ratio which shows increased theta activity (except for ADD-I, which shows a different pattern). I think you will find that no body of literature shows all studies with the same results. Finally, this procedure is not supposed to be used in isolation to diagnose ADHD, but in conjunction with other aspects of diagnosis. As for using this procedure as the sole basis for diagnosis, really the cheapest method would be just to use the behavior rating scales, which has not happened.

[empeg1]

Finally, the test of brain waves with ADHD diagnosis brings me back to my interest in neurofeedback. My youngest dd, who does not have ADHD, but anxiety and a sleep disorder, showed marked improvement in sleep with neurofeedback. She slept through the night for the first time in her life 20 years. I am very interested too in neurofeedback for my oldest dd re FASD. There is a large body of literature regarding the use of neurofeedback in the treatment of TBI. I realize what I am bringing up in anecdotal, but several friends in the last number of years have incurred post concussion syndrome aka mild TBI, with persisting symptoms of memory loss, disorganization, difficulty in concentration, fatigue, headaches...... Three have gone to neurofeedback and all three saw a marked reduction in symptoms; 2 of whom were able to return to work when they formally could not do so full time. So, I am thinking, the above may be worth a try.