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More on Neurofeedback’s Brain Training Value

(Note: neurofeedback is a form of biofeedback that measures brain waves and that, according to practitioners, provides good “brain training” for specific clinical conditions).
A few weeks ago Dr. David Rabiner wrote a great post on How Strong is the Research Support for Neurofeedback in Attention Deficits?, concluding that

– “It is for these reasons that neurofeedback is understandably regarded as an unproven treatment approach for ADHD at this time by many ADHD researchers.

– However, these studies do provide a solid basis for suggesting that if parents choose to pursue neurofeedback for their child, there is a reasonable chance that their child will benefit even though we can’t be sure that it is the specific EEG training that is responsible for the benefits. Thus, although the efficacy of neurofeedback has yet to be conclusively confirmed in a randomized, placebo-controlled trial, it is important to place this limitation in the context of the supportive research evidence that has been accumulated.

– Providing this context can help families better understand the strengths and limitations of the existing research on neurofeedback and enable them to make a better informed decision about whether to consider this treatment option for their child.”

This post prompted several good comments, one of which is reproduced below in its entirety, since it adds an interesting perspective.
Bernard writes: My wife tried EEG neurofeedback over 10 years ago in the hopes of normalizing her brain functioning to overcome lifelong epilepsy. She had a history of multiple, daily absence seizures and grand mal (tonic clonic) seizures once every two years.

After 3 and a half months of twice weekly sessions, we almost gave up on the neurofeedback. It was burning a hole in our wallet (no insurance covered it) and we were not seeing any results. However, we stuck with it (mostly because my wife refused to poison her liver with anti-epileptic drugs).

After 5 months, it was like someone had turned a switch. She stopped having seizures, was calmer, had better memory and cognitive functioning (thinking clearer). We stopped the neurofeedback sessions and she went 4 years without a single seizure event and likely would still be completely seizure free today we had not started a family (her TC seizure activity returned, but not the absence seizures, and got progressively worse with each pregnancy – but that’s a different story).

After our experience, I did as much digging as I could about EEG neurofeedback (see http://www.coping-with-epilepsy.com/forums/f22/eeg-neurofeedback-501/ ) and I’m really outraged that the medical industry continues to “poo-poo” the resounding body of evidence for it.

Snippets from my findings:”Randomized double blind placebo controlled clinical trials (RCT) are the current “gold standard” for demonstrating clinical efficacy of new drugs or therapies. It is very difficult for new therapeutic interventions to gain broad acceptance in the absence of such trials. Recent events have raised serious questions about the conditions under which placebo (sham) controls can be used. The international standards published by the World Medical Association (Declaration of Helsinki) prohibit placebo-controlled studies when known effective treatments exist. Additionally, there is new interest in identifying the mechanisms underlying the placebo response, which may challenge the “placebo” as a legitimate control condition. Both of these events should be of considerable interest to those interested in clinical psychophysiology in general and neurotherapy in particular. ”

“Recent New England Journal of Medicine reviews of research design have cast doubt on the need for placebo controlled designs. Their review has shown that when there is a preponderance of case series reports, the concordance between those results and those of the “gold standard” (double blind placebo controlled studies) was very high. Many in the field are now arguing against doing a double blind study due to the lack of proper humane treatment of those in the control group (receiving no treatment), an approach which is also now considered unethical by the World Health Organization when known treatments exist.”

“Since the first single-case study, reported over 30 years ago (Sterman & Friar, 1972), a fair number of controlled clinical studies, stemming from many different laboratories, have produced consistent data on the efficacy of SMR training in epileptic patients. It is particularly noteworthy that these results have been achieved in an extremely difficult subgroup of epilepsy patients, those with poorly controlled seizures who had proven unresponsive to pharmacological treatment. We will here provide only a cursory overview of this clinical research literature. For a more detailed treatment the interested reader is referred to Sterman (2000), while other recent summaries have also been provided by Monderer et al. (2002), and Walker and Kozlowski (2005).


In reviewing the data accumulated in these studies, Sterman (2000) found that 82% of 174 participating patients who were otherwise not controlled had shown significantly improved seizure control (defined as a minimum of 50% reduction in seizure incidence), with around 5% of these cases reporting a complete lack of seizures for up to 1 year subsequent to training cessation. …”

Because of the problems with designing a gold standard study, the Association for Applied Psychophysiology and Biofeedback (AAPB) has developed their own rating scale for measuring efficacy of neurofeedback for a given condition:

Rating explanation:
http://www.aapb.org/i4a/pages/index.cfm?pageid=3336

Conditions with ratings:
http://www.aapb.org/i4a/pages/index.cfm?pageid=3327

What really gets my goat is that EEG neurofeedback has been studied now since the 60s – almost 50 years and there have been no reports of iatrogenesis (a harmful effect produced by the healer or the healing process): “Fortunately, adverse reactions to biofeedback training are overall rare, and when they occur they are relatively transient or readily dealt with by competent practitioners (Hammond, 2001; Schwartz & Schwartz, 1995).”

So here we have a treatment option that has been studied for over 50 years, has no negative/side/adverse effects, has tons of evidence supporting it’s efficacy, but doesn’t have a single commercial entity that “owns” it in the same way that drug companies and medical device companies own their solutions. No company is pushing for FDA approval – or studies – or marketing it, because it’s not cost effective for them.

Cyberonics was able to get FDA approval, acceptance by the neurology industry and insurance coverage for their VNS medical device for epilepsy with studies showing more dubious efficacy than EEG neurofeedback and with well established, potentially serious adverse risks. It truly infuriates me to see how the commercial aspect of the medical industry drives options for patient choice in treatments.

———————-

(Note:  I will now bring the few comments that followed, so it is easier to continue the conversation here).

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9 Responses

  1. Alvaro says:

    Dear Bernard, thank you for such a detailed response. If you don’t mind, I will publish it as its own post next week, so that more people can see it, and respond.

    You raise many good points. And I am happy that neurofeedback helped your wife. Now, nothing that you have written, in my view, contradicts Dr. Rabiner’s conclusion. Furthermore, the fact that neurofeedback has been around for so long, may make one question why no one attempts the type of study he proposes.

    In fact, in those same ratings you link to, one can see only one application reaches Levels 5, and it is not ADD/ ADHD. Which is basically what Dr. Rabiner is saying, with other words.

    This is not about drugs vs. no drugs. Some non-drug-based approaches, such as cognitive therapy or forms of computer-based working memory training are starting to show efficacy as complement to drugs in well-designed trials. And it is not about biofeedback in general, which has clear research support for specific applications.

    You may know that companies like Play Attention sell neurofeedback machines direct to parents, for use with kids who have ADD/ ADHD. Have you seen research supporting an investment of more than $1,000 in such programs? They may work, and parents are free to spend their money as they want- but they deserve to know that it is not proven.

  2. Bernard says:

    Hi Alvaro,

    I don’t mind if you republish the comment.

    Play Attention is not a full fledged neurofeedback machine like the ones used in studies. It only processes (IIRC) the alpha wave channel. EEG Neurofeedback machines like Brainmaster’s Atlantis system, Zengar Institute’s NeuroCare system, etc. manage up to 5 wave channels – alpha, beta, theta, delta and (sometimes) gamma. It also doesn’t perform QEEG mappings, so it is not on the same level as a treatment option as EEG neurofeedback as defined in the studies.

    “Furthermore, the fact that neurofeedback has been around for so long, may make one question why no one attempts the type of study he proposes.” – Alvaro

    ~~~

    “The most conclusive test of neurofeedback treatment would include random assignment and a control condition that closely matched the neurofeedback condition. For example, children could receive video game coaching from a supportive adult for the same time period. Or, even better, they could do exactly what children getting the neurofeedback were doing but not receive direct feedback on their EEG states.” – Dr. Rabiner

    ~~~

    EEG neurofeedback is not a “treatment” in the classical sense. It is a training program that requires tailoring over time by the practitioner and active participation from the patient. It is not possible to simulate this effectively over time for a “blind” study, much less a double blind study.

    But the larger answer as to why no one attempts the type of study he proposes is $$$:

    “For a very promising treatment targeting such a
    serious condition as epilepsy, the number of large-scale clinical trials of neurofeedback
    training to date is disappointing. A likely reason for this state of affairs is that
    neurofeedback research is a very time- and work-intensive enterprise that has
    traditionally not received extensive research funding and has, for obvious reasons, not
    been pursued by the pharmaceutical industry.”

    http://sica.stanford.edu/events/brainwaves/FoundationsofNeurofeedback.pdf

    As I mentioned previously, no company owns a patent on EEG neurofeedback – it’s a training process, not a drug or specific medical device. It is not economically justifiable for a for-profit company to sponsor the necessary research. There is no ROI. So, it’s up to non-profit groups/charities to sponsor this kind of research. While some have sponsored small studies recently (such as FACES at NYU), there hasn’t been and isn’t anything being done on the scale that appears to be necessary for the skeptics.

  3. Alvaro says:

    Hello Bernard, you raise some good points but, net net, the situation is what Dr. Rabiner describes: neurofeedback is promising, and may well work, but it is unproven according to scientific standards.

    Parents/ other users need to make their own decision on whether to use neurofeedback or not, as a tool in the toolkit, with its Pros and Cons. There is not enough clinical/ scientific evidence to warrant a wider, automatic “prescription”.

  4. Bernard says:

    “There is not enough clinical/ scientific evidence to warrant a wider, automatic “prescription”.”

    How much is enough?

  5. Alvaro says:

    Hello Bernard, with all my respect, it is not even close.

    One thing is to argue that neurofeedback may be an appropriate tool in specific cases where a clinician can suggest that intervention makes sense and the patient agrees to try, and another one to imply the tool deserves a wider, automatic “prescription”. For the later, you’d need many high-quality randomized controlled trials-the type that Dr. Rabiner was suggesting neurofeedback, at least in the case of attention deficits, has none.

    Which doesn’t mean neurofeedback isn’t a valid option. It CAN be. Let me revisit  one of David’s sentences: “However, these studies do provide a solid basis for suggesting that if parents choose to pursue neurofeedback for their child, there is a reasonable chance that their child will benefit even though we can’t be sure that it is the specific EEG training that is responsible for the benefits.”

    If neurofeedback practitioners need to go beyond this, they need to enlist some university-based researchers and conduct a good trial. Perhaps the military would be interested in funding such a study.

  6. Peter Freer says:

    The information regarding Play Attention is incorrect. It is not an alpha trainer. It is a physiologic monitor that cannot be augmented from factory settings like an EEG device. I wanted to make it clear that Play Attention is not clinical neurofeedback and has never strived to be. Frankly, we don’t try to change brainwaves and are unconcerned with their change. We are concerned with cognitive and behavioral outcomes. The feedback used is simply to place the student in an attentive state to learn deficit skills like time on-task, memory, filtering out distractions, visual tracking, auditory processing, etc. We have a patent pending on our integrated behavioral shaping component as well. Neurofeedback proponents have maintained that changing brainwaves facilitates learning of these skills, however I find that rather facile. Changing a brainwave does not insure that I will learn to finish homework on time, have better short-term memory, etc. If that occurs, it’s simply by coincidence not by osmosis. We strive to teach these skills directly.

  7. Alvaro says:

    Hello Peter, thank you for your comment.

    What you say makes a lot of sense. Now, the questions then become, how exactly do you train cognitive skills, and how do you show the “cognitive and behavioral outcomes” from your product? We have not come across peer-reviewed published studies that we can evaluate and discuss in this blog. And we would love to, given the number of years your product has been in the market.
    Thank you

  8. Peter Freer says:

    What I say does make sense. Specifically, one teaches cognitive skills. We casually call it training, but cognitive skills can be taught. This has been done historically since the time of Socrates. The feedback insures we have student attention. It activates and controls cognitive activities like working memory practice, spatial memory, time on-task, visual tracking, auditory processing, attention stamina, etc. If the student fails to maintain maximum attention, the game stops, alerting them to focus-in once again. We then quantify how much memory improves over time, teach students to finish assignments on-time, measure visual tracking ability, etc. Then we spend a lot of time on strategies to transfer and generalize these skills.

    We’ve received 3 patents based on this approach. We also have a patent pending behavior shaping module integrated so that students can learn to self-regulate by learning to focus more. It’s far too difficult to explain in a short response like this.

    We have an ongoing controlled study at Tufts Medical School, are beginning one at Harding University, and are starting one in a public school district next year. Data should be published in late 2009.

    The reason we’ve survived and ruled this market internationally for 14 years is because our method makes sense, is founded in sound teaching practices that are thousands of years old and integrated them with feedback technology. That’s so radically different and refreshing that we are in more households, TBI hospitals, psychologist’s offices, MD’s offices, learning centers, and schools (over 450 districts in US alone) that no one in this industry comes close. Could we have done this if Play Attention didn’t work? Not likely. Furthermore, what we’ll introduce both technologically and educationally over 2008 will alter the future of this industry once again.

    These forums are notorious for wrongly interpreting or describing Play Attention which is what occurred here. I only meant to correct that. One should be responsible or at least knowledgeable before making statements especially on a respected forum such as this.

  9. Bernard says:

    I have referenced this discussion in a letter to the American Academy of Neurology:

    http://www.coping-with-epilepsy.com/forums/f37/pushing-neurofeedback-into-mainstream-5418/

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