Pushing neurofeedback into the mainstream

[Bernard]

I'm going to document my efforts to push EEG neurofeedback into the mainstream here. This thread is not for discussions. Discussions about these efforts can be discussed here.

On December 10, 2008 I sent variations of the following email to ISNR, AAPB and EEGInfo:

I woke up this morning with a burr in my saddle. I had an epiphany of sorts. I have contacts with epilepsy research foundations, EEG neurofeedback associations and "intractable" epilepsy patient populations.

So, I want to organize a well designed, rigorous, large-scale distributed study to "put EEG neurofeedback on the map" - a study which could not be ignored. I'm sending feelers out this morning to explore the possibility and get a clearer picture of the necessary scope.

As an industry advocate for neurofeedback to the insurance carriers, I was wondering what kind of feedback you are receiving with your efforts to get better insurance coverage for EEG neurofeedback (specifically for epilepsy). What would it take to get them on board? How large would a study have to be to get their attention? 1,000 patients? More? I asked this question to a skeptic once, but didn't get a qualified answer:

http://www.sharpbrains.com/blog/2008/02/24/more-on-neurofeedbacks-brain-training-value/

This was a follow up to a post from Duke University's Dr. David Rabiner, who was lamenting the lack of scientific rigor in neurofeedback studies for ADD/ADHD:

http://www.sharpbrains.com/blog/200...eurofeedback-treatment-of-children-with-adhd/

I would definitely like to talk to any ... members who might have the proper background and interest in helping to define the structure of a study that will hold up to the strictest scrutiny.

To date, I have received correspondence from both Dr. David Trudeau, President of the ISNR Research Foundation, and Dr. Siegfried Othmer @ EEGinfo.

Dr. Othmer posted an instructive lesson on the daunting challenges we face. So, I decided to contact the top dog at the organization which I think holds the key to the puzzle. On January 2, 2009, I sent the following email to Dr. Christine Phelps, Deputy Executive Director (Center for Education and Science) for the American Academy of Neurology/AAN Foundation:

Dear Christine,

I found your contact information listed as the Deputy Executive Director for the American Academy of Neurology/AAN Foundation. I am hopeful that you are the correct individual to direct this message. If not, could you please forward to the appropriate contact(s).

I am writing to you today because I am very, very upset. I've reached the Howard Beale "Mad as Hell and I'm not going to take it anymore" nexus and am compelled to take action. I am writing to the AAN to ask a simple question. But before I do, I need to explain a little bit about my background and the issue at hand.

My wife has epilepsy. Over the course of the last 12+ years, I have ridden an intense, fascinating and humbling rollercoaster ride. You see, my wife despises pharmaceutical drugs. In our early years, she would refuse to take any AEDs. As a result, we have explored many alternative approaches to seizure control with varied levels of success and failure.

In early 2005, I created an online discussion forum for epilepsy. I later discovered that there were already several very active forums just like it. In the course of the last 3 years, I have met thousands of people with epilepsy and read even more first person experiences. I am very well acquainted with the entire epilepsy experience.

As I see it related day in and day out, neurology as a profession offers epilepsy patients 3 basic treatment options - drugs, surgery or implant device(s) - with an occasional look at diet. I understand the rationale for using drugs as a first line treatment option, but they don't work for everyone. And a subset of those for whom they do work, the side effects are unbearable (ie. the quality of life equation doesn't favor taking the drug for seizure control). Not everyone is a candidate for brain surgery either.

It is within this section of the epilepsy population, commonly labeled intractable or refractory, that has the greatest representation in online communities. It is within this sphere that I have dwelled for several years.

For many patients in this realm, the primary recommendation appears to be an implant device (Cyberonic's VNS or a trial for NeuroPace's or Medtronic's devices). There are other alternatives. In fact, when considered side by side in terms of efficacy (per published studies), known potential adverse events/effects, cost, type (active/passive action) and latency (how long before results are realized), it becomes clear that there are alternatives that are far more attractive. For reference, please see:

http://www.coping-with-epilepsy.com/index.php?p=alternative-treatments

I don't know if the lack of exploration for better options is simply a matter of time, revenue or ignorance, but from a patient's perspective, the folks in the intractable/refractory category are very motivated to adhere to any treatment regimen (such as a special diet) that might help. Certainly trying a diet, neurobehavioral therapy or EEG neurofeedback ***would do no harm***.

Therein lies the rub.

My wife was very fortunate to find some open minded and progressive doctors roughly 10 years ago who suggested she try EEG neurofeedback in addition to a special diet (similar to the LGIT) and nutritional supplements. The combination worked like magic for her. I have spent quite a bit of time researching EEG neurofeedback (and other alternatives) ever since.

I shared part of my journey here:

http://www.coping-with-epilepsy.com/forums/f22/eeg-neurofeedback-501/

Now we get to the interesting point. Even though many of the early studies on neurofeedback were not rigorous in nature (employing randomized controls), there is sufficient data to consider EEG neurofeedback as probably efficacious. Sterman's meta-analysis in 2000 reviewed studies encompassing 174 patients (most of which were in the intractable/refractory category) and showed very promising results (82% demonstrated significant (greater than 30%) seizure reduction, with an average reduction exceeding 50%). In addition, there is no need for concern about adverse effects from trying EEG neurofeedback (as reported by Hammond, 2001; Schwartz & Schwartz, 1995) - there are no reports of iatrogenesis (a harmful effect produced by the healer or the healing process) through the use of neurofeedback in a clinical setting.

When I started investigating Cyberonics' VNS system, I was shocked by what I learned. Here is a device that gained FDA approval for epilepsy with studies showing far less promise for efficacy, with no known/understood mechanism for any therapeutic effects and with known and potentially life threatening adverse effects. The VNS is aggressively marketed and often recommended to epilepsy patients even when other first line options are not explored.

A bit more background on the VNS:

Houston Press article about VNS
http://www.houstonpress.com/2005-04-07/news/exposed-nerve/

Guy who was nearly killed by the VNS digs up pages and pages of MAUDE reports concerning the VNS and patient deaths
http://z4.invisionfree.com/VNS_Message_Board/index.php?showtopic=3076

My thoughts on the mechanism of action for the VNS
http://www.coping-with-epilepsy.com/forums/f23/vns-therapy-crude-form-eeg-neurofeedback-1189/

The initial studies done for the VNS to gain FDA approval involved a sampling size of a couple hundred people. There are studies being conducted right now for two more epilepsy implant devices that also involve just 100-200 patients each:

Preliminary study results of new implant device for epilepsy
http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1228746390966&lang=en_US

Results of preliminary study for another implant device for epilepsy
http://www.neuropace.com/about/news/0612.html

The sampling sizes on these studies is not any greater (actually much smaller) than the preponderance of studies done on EEG neurofeedback. I find it puzzling that the medical profession can embrace these medical devices on the one hand and claim neurofeedback is "controversial" and/or "unproven" on the other.

Dr. Rabiner argues in the article he wrote (see the link below) that neurofeedback studies need random assignment and an appropriate control group in order to be taken seriously. Another critic argued that the combined size of studies published to date is too small a sample to mean anything.

http://www.sharpbrains.com/blog/200...eurofeedback-treatment-of-children-with-adhd/

http://www.sharpbrains.com/blog/2008/02/24/more-on-neurofeedbacks-brain-training-value/

So, my question is, what is it going to take for the medical profession (in this case the AAN membership) to accept EEG neurofeedback as a valid option for treating seizure disorders? Is a randomized, controlled study of ~200 people (only half of which are getting the real treatment) sufficient? It appears to be sufficient for medical implant devices - devices that, as far as I can tell, are performing a similar function to neurofeedback in regulating brain function. Would that be enough for the critics? What if the study had ~400 people?

I don't ask this question idly. I am in contact with the AAPB, ISNR, epilepsy research foundations and other key individuals and am looking to push the issue.

It's time for the medical community to offer epilepsy patients some real choice. It's time for insurance carriers to help them.

If you support what I am doing with this, I would ask you to please click on the link for the AAN. It would be good for their webmaster to report to them that they are getting a lot of interest from this thread. You might also consider writing your own letter/email to the AAN.

 

[Bernard]

For those who did not understand the Howard Beale reference and didn't want to take 10 seconds to look it up on the internet:

 

[Bernard]

To date, I am receiving a lot of high level contact with members of ISNR and the neurofeedback industry who are very interested to help with this initiative. *When* the AAN is able to formulate an answer as to what it is going to take, I am sure there will be plenty of capital in terms of expertise to design and conduct a study to meet their criteria.

I was about to prepare a letter to Eric Hargis, current president of the EFA, when I received an email from Joseph LaMountain, Director of Grassroots Advocacy @ EFA (his timing was impeccable). So, I sent him the following on January 7, 2009:

Hi Joe,

Your email is very timely. I am hopeful that you could be of assistance to me.

Please have a look at this letter I wrote (and published online) and let me know if there is anything the EFA can do to push the AAN to respond:

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

I would really like to see more choices for epilepsy patient care.

I have also received contact from an epileptologist in the northeast who is interested in exploring the possibility of collaborating with a local EEG neurofeedback provider as part of a center for epilepsy treatment. This is still very preliminary so I'm not disclosing details as yet. I did want everyone to know that this initiative *is* reaching people.

We do have a voice. I encourage you all to use yours. Contact the AAN (they have email addresses posted all over their site - just not on the contact page... :roflmao and tell them you are interested in seeing an honest answer to the questions I posed. Let them know this is important.

 

[Bernard]

I have exchanged a several emails with Joseph LaMountain, Director of Grassroots Advocacy @ EFA and I'm not sure that he ever took the time to read/review the letter I wrote to the AAN. His last letter to me indicated that he didn't think he could be of much assistance. My last letter to him, sent January 14 at 3:59pm:

Hi Joe,

Thank you for the feedback. I appreciate your candor.

I'm disappointed that the EFA Grassroots Advocacy cannot be of any assistance in asking the AAN what threshold criteria would be necessary to start considering EEG neurofeedback as a mainstream treatment option for epilepsy . It seems to me to be a simple and innocent enough request in line with the EFA's mission.

I hope that you might reconsider. The EFA speaks with a much stronger voice than a lone individual such as myself - even if it's just to ask a question.

I will continue to pursue the matter as best I can.

Last night, I joined in a chat room at blogtalkradio to ask Dr. Steven Schachter, current President of the American Epilepsy Society and former editor-in-chief of epilepsy.com, some questions for his internet radio program on the topic of Complementary Therapies for Epilepsy (you can listen to the hour long program directly on your media player via this link). Here is a partial transcript of the show where he addressed my questions:

@ 23:37 -> Patty: OK, there is another question here, um... regarding ... this is from, I believe Bernard, uh... from Coping With Epilepsy. Ah. He says hello Dr. Schachter. He's wondering what criteria needs to be met before neurologists will consider EEG neurofeedback to be proven and accepted as a mainstream treatment option.

@ 23:59 -> Dr. Schachter: Well, you know I can't speak for all neurologists, but for me, what um.. I evaluate with any therapy, including, you know, FDA approved products, is the balance between the potential benefits and the potential risks. And those ... you, you can read about those on a piece of paper, but you have to individualize that assessment for each and every individual patient ... and, umm.. I .. you know we generally look for evidence of risks and benefits from studies that are done in such a way that the results can generally be believed. In other words, that the study design was set up in a way that if there was an effect found, that it is very likely to have been the effect from the treatment - in this case neurofeedback. Um, in my own practice, if a form of treatment has been thoroughly studied and the associated risks seem to be minor or non-existant, then, you know the .. um, the benefit that would need to come from that is not necessarily as definitive as you would expect if you were doing a, you know, recommending a treatment that has significant risks. So, you know, in my own practice, I would, um, if a patient came, you know, requesting a particular form of therapy or a referral for that type of therapy, if as we looked at the known information about the risks and benefits, it appeared, for that person that the potential benefits outweighed the possible risks, then, in my opinion it's worth a try. But that assumes that the treatment has been studied well enough to have a clear understanding what the possible benefits are and the potential risks, and uh... I have not personally studied neurofeedback, nor am I that familiar with the studies that have been done, but as a general principle, that would be my approach and I think most neurologists probably would agree with that. There are some doctors who, um, may have a ... an inclination against CAM therapies because it's not mainstream medicine, but if the evidence .. .if the results of clinical trials are convincing enough to make this risk benefit assessment and to individualize it, then I think that it becomes a very important part of the physician recommending or agreeing that their patient should try it.

@ 26:52 -> Patty: I'd like to add in one other part, that many times therapies might first be studied for one condition and then someone might find that they might be helpful in seizures. So, not only do you need to do the research again and see that it is reproducable in seizures, but then the payors and insurance companies would need to be convinced that a therapy is effective enough as you said - so they would pay for it. So while you need the research to say it is helpful, you then need other people down the line to say that it could be, kind of mainstream and paid for - in order for people to use that.

@ 27:35 -> Dr. Schachter: Right. And, because, we're always on the lookout for potentially new, effective therapies, I encourage people that have experienced a very positive, or negative, effect from any kind of therapy that we're talking about tonight to somehow bring that to the attention of a neurologist or an epilepsy specialist. One of my goals with epilepsy.com, which unfortunately I didn't have time to do, is to set up a way for people to express, you know, on a one by one basis, if they found a particular treatment that is not mainstream - was unbelievably effective or, on the other hand, made things worse ... because that is how ... those types of obversations that become the seed for .. or become the basis for futher research being done. And, uh, it's so important to make these experiences known to researchers so that they can be further studied.

@ 28:39 -> Patty: Yeah. Don't assume that your doctor is not going to be interested. Sure.

~~~~

@ 47:14 -> Patty: Here is a follow up comment on, uh ... on the neurofeedback. This person has said that there is no reports of harmful effects, but uh, my personal feeling is that until something is fully tested, you don't know what are the beneficial versus harmful effects. Um, the question is in order to get a large study to see how helpful neurofeedback is, how large a study would be necessary to prove this?

@ 47:47 -> Dr. Schachter: That's a great question and ... it depends on, uh ... how effective you estimate it's going to be. When a clinical study is being designed, the number of people that are projected to be needed to study, uh ... that number depends on what your estimate is of how effective it's going to be. You know, for example, if a therapy is extremely effective, then a relatively small number of people may be necessary. If the difference between a therapy and a placebo is very minimal, but yet definite, it may take hundreds of thousands of people. So, um ... you know, most um ... initial studies tend to be in the range of 50 to 100 patients just to get a sense of how effective it might be and then to plan a very large trial ... and, you know the Epilepsy Therapy Project is ... is dedicated to advancing new therapies for epilepsy, and ... and including therapies like we're talking about tonight, and ... if there was ... you know, uh ... a solidly written scientific proposal for a study evaluating the feasibility or ... develop some evidence for safety and benefit of an intervention like neurofeedback ... that's something that the Epilepsy Therapy Project would review in it's grant review process. The NIH, through it's ... what's called the national center for complementary and alternative medicine funds large scale studies of these types of therapies that we're talking about tonight. And so, there are ways for researchers to get this type of work funded, and, you know, I'm encouraging my colleagues every chance I get to pursue research in all these areas, as I can, and to help identify funding sources so that the work can be moved forward.

@ 49:57 -> Patty: Great. Well, so that's certainly some helpful hints here in terms of where people can go in looking for funding. ...

~~~~

@ 55:15 -> Patty: What's your view of the work done on neurobehavioral therapy through the Andrews-Reiters clinic?

@ 55:21 -> Dr. Schachter: I'm sorry?

@ 55:23 -> Patty: Ah.. Your view of the work done at the Andrews-Reiter clinic with neurobehavioral therapy.

@ 55:30 -> Dr. Schachter: Um, you know, I've been very impressed by their work, and I've met both Diana Andrews and Joel Reiter, and ... it's a form of treatment that can be studied and ... in clinical research, and ... I think they've made excellent progress. There are a variety of behavioral therapies that are currently being studied. Um... a group in Sweden visited with me this past summer for a month or so and we exchanged information and decided how to move forward with research. So, you know, clearly, any and all cognitive based therapies or behavioral modification therapies are certainly worth exploring and trying to test, because, by virtue of the fact that they're, you know ... they don't involve drugs or chemicals ... uh the, you know the ... potential side effects would appear to be less than in the case of taking some sort of plant product or a chemical. But, uh ... either they're ... I'm aware of probably 5 or 10 different programs that have developed to try to teach individuals to recognize their state of mind or the warning signals that a seizure may be more likely to occur and then to put into place some intervention to lessen the risk of that, and ... I encourage research like that as much as I possibly can.

@ 57:10 -> Patty: Great. ...

The quest continues.