A call to arms for epilepsy patients and advocates

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-train...

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/2008/01/25/how-strong-is-the-research-support...

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-neu...

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...

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/2008/01/25/how-strong-is-the-research-support...

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

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 consider writing your own letter/email to the AAN.