NeurOptimal finally admits not to be Neurofeedback

Launched 7 months ago, the objective of my blog was twofold. On the one hand, I wanted to provide you with quality information on neurofeedback, but also and above all, I wanted to get information on the subject. It is often not discussed very much, but popularizers also learn a lot as a result of their work and it is this desire to learn that pushed me to get started.

On this existence, I can give you some statistics :

• the articles totaled more than 9,000 readings ;
• put end to end, they make 100 pages in A4 format ;
  
• the most popular article is "Finding, accessing, reading, reading, translating and understanding science", thanks in particular to the Zététique group where it was shared ;
  
• 150 emails were received via my contact form ;
  
• I met several of you to talk / introduce Neurofeedback and as a result, three of you followed the Neurosens Institute training (rather than the NeurOptimal one) ;
  
• I have been contacted by investment funds to discuss the scientific evidence of Neurofeedback and the Mensia Koala solution ;
  
• I won €0 through this blog.

Since March, a lot has changed in my approach to Neurofeedback and my understanding of the technique. My meeting with Ruben Perez and Thomas Feiner was very enriching and I am writing an article/interview of Thomas and his IFEN certification (an improved version of BCIA's) because I think it is important for the French people to know what is being done elsewhere in the world. I also secretly hope to be able to interview you Thomas F. Collura from Brainmaster, because in my opinion, that would also be very interesting.

But what has really changed is NeurOptimal. I had a lot of criticism and emails certifying that the NeurOptimal was Neurofeedback, that it was supported by scientific evidence, etc.... I spent time defending my evidence-based position and falling in the face of empty, argumentatively biased speeches.

Today, thanks to you (well, an anonymous source), I can finally tell you: NeurOptimal is changing its communication, recognizing the therapeutic effectiveness of Neurofeedback and recognizing that it is none of the above. Finally, according to a NeurOptimal representative and instructor.

In this e-mail, five elements are addressed :

• NeurOptimal would have been "evaluated" by the FDA ;
  
• Neurofeedback is a therapeutic practice ;
  
• NeurOptimal is a practice of "well-being" (who knows why the quotation marks are used) ;
  
• We must now call the technique underlying NeurOptimal as "Dynamical Neurofeedback" ;
  
• NeurOptimal is committed to stop using scientific studies about Neurofeedback to promote its own solution.
  

So, you know me now, let's go through it with a fine-tooth comb.

NeurOptimal evaluation by the FDA

The FDA is the Food and Drug Administration. According to Wikipedia (which we like, eh), "this organization has, among other things, the mandate to authorize the marketing of drugs in the United States".

And this is the first wall I've ever eaten myself. Why would an organization that manages drugs and food be interested in NeurOptimal? I mean, look at the FDA website. There are tabs for food, medicine, medical devices and lots of other very serious stuff.

When I read the FDA's English Wikipedia page (more detailed), I find nothing about a classification that might correspond to NeurOptimal.

But I'll be honest: it doesn't seem extraordinary to me that NeurOptimal has been "evaluated" by the FDA: this administration is perhaps larger than I think and we need to define precisely what this "evaluation" implies. It may just be paperwork to say that it is safe, without assuming any effectiveness. That is quite possible. So I searched the NeurOptimal website. Nothing. Nada. However, I noticed that they had removed their "Research" tab from the site (although the pages are still online using their search engine) and their communication has been changed.

I still played on the FDA website, entering "NeurOptimal", "Zengar" and "Neurofeedback" everywhere, but I invariably came across the message "no records were found with Device: neuroptimal Decision Date to 10/27/2018"... so here it is.

I still continued my investigation on the Internet, because so far, all the documents I have stipulated that NeurOptimal has not been evaluated by the FDA (for medical purposes).

This type of consent form is still available on the Internet, including on the ADNF website, today :

However, by digging a little deeper, I found this document, which seems to be the only one that addresses FDA approval of NeurOptimal:

Here, it is mentioned that NeurOptimal has received FDA approval for use in relaxation. This is a little far from my previous articles, where I noted that NeurOptimal's communication advocated her ability to treat a whole bunch of pathologies. And I also pointed out in this article that NeurOptimal could be used as a relaxation device, as one asks the person to be calm. I like it when people say I'm right, a little thought for yesterday's me who worked well.

This document is the flyer of a lecture given by Jan Yordy, who holds a double master's degree in social work and education -she is neither a doctor nor a scientist- at the 20th Annual Canadian Conference on Energy Psychology. Is this something serious? If you want:

• follow healing touch sessions ;
  
• learn to diagnose and heal yourself through your dreams ;
  
• wake you up to your internal energy wiring ;
  
• train you in radiesthesia (capturing the "energies" that surround us, a big newage bullshit) ;
  
• communicate with your soul ;
  
• or..... talk about quantum DNA.....
  

Well, you've come to the right place. But this is no place for me. I am too young to commit suicide following a complete loss of faith in humanity in front of these conferences.

Then, on Yordy's website, she presents the NeurOptimal as a technique that will cure you of all ills, with of course, on the right, your cart, because Yordy, she is there to sell you things, above all.

So, it's not very serious.

But I said it earlier: honestly, I don't think NeurOptimal is lying about the FDA's evaluation of NeurOptimal. But in my opinion, it is oversold, so it is important to understand exactly what it is and how it works.

However, it must be understood that by using a search engine with the keywords "NeurOptimal" and "FDA", we invariably come across sites that talk about the fact that the FDA has recognized neurofeedback effective in stress management. The big problem is that all these sites share the same copied/pasted sentence (after all, they already do the same with their "user testimonials".......) :

This gives in full version, once you go to these sites :

The U.S. Food and Drug Adminstration has approved neurofeedback for relaxation training and the American Pediatric Academy has endorsed neurofeedback as a “Level 1/Best Support” treatment for children with ADHD. (...) Because neurofeedback has been time-tested, it is also very safe. Respected institution such as the U.S. FDA and the American Academy of Pediatrics have endorsed neurofeedback.

The problem is that, to my knowledge, the FDA has not approved Neurofeedback (on the other hand, Biofeedback is subject to regulation and the EEGq NeuroGuide database is approved as well as many EEG-(Neurofeedback) materials). It would be NeurOptimal that would be approved for relaxation. On the other hand, the American Pediatric Academy has clearly recognized that neurofeedback is a therapy of choice for ADHD. So, we have a sentence that happily mixes NeurOptimal and Neurofeedback and Zengar's representative tells us : it's not the same thing.

So I was a little confused at the time. But in the course of my research, I came across an FDA draft that talks about a new product category called "General Welfare: Low Risk Materials Policy -- Guidance for Industry and FDA Staff". It is a document dated mid-2016, which addresses guidelines for wellness products :

The CDRH defines general wellness products as products that satisfy the following two factors: (1) are intended solely for general wellness purposes, as defined in this manual, and (2) pose a low risk to the safety of users and other persons. General wellness products may include exercise equipment, audio recordings, video games, software, programs and other products that are generally, but not exclusively, available from retail establishments.

Further on, is specified :

"The first category of intended uses of general well-being concerns claims for the general maintenance or improvement of functions associated with a general health condition that make no reference to diseases. For the purposes of this guidance document, this first category of claims is :

• weight management,
  
• fitness, including products intended for recreational use,
  
• relaxation or stress management,
  
• mental acuity,
  
• self-esteem (e.g., devices with a cosmetic function that make claims related solely to self-esteem),
  
• sleep management, or
  
• sexual function."
  

BINGO! I had just found new evidence: an FDA document that talks about relaxation. So we have the definition of a product "General well-being", now the part on "low risk materials":

"The CDRH's general wellness policy applies only to low-risk general wellness products. If the answer to any of the following questions is YES, the product is not low risk and is not covered by this guidance.

• Is the product invasive?
  
• Is the product implanted?
  
• Does the product involve an intervention or technology that may pose a risk to the safety of users and others if specific regulatory controls are not applied, such as risks related to lasers or radiation exposure?
  

NeurOptimal is not invasive, nor implanted, and does not use any laser or radiation, so for me it fits this definition perfectly.

Therefore, NeurOptimal, according to the FDA, would be a "low-risk general well-being" product.

Except that, by searching on the Internet, for example on this site or on this one, you can read : 

The FDA has finalized a directive stating that it does not plan to review low-risk "general wellness products", such as portable fitness monitors or sleep monitors, and will not require them to comply with regulatory requirements before and after marketing.

I continued to dig and came across this document, a presentation of 40 slides on this type of product, which seems to be along the same lines: there is no need for a statement to the FDA.

And let us not forget: as French people, the FDA's decisions do not concern us. Europe often has stricter policies than the USA. So it's a clue, a lead, not evidence. Because between the American approach and our European approach, there can be a world.

Here, I was lost. NeurOptimal certifies that the product is evaluated by the FDA and after my research, I find that this product category does not require an evaluation...

....

...

....

Well, so I asked the FDA directly, by sending them an e-mail.

As we saw in the article I did in collaboration with the AAPB, Americans don't laugh too much. I had to sign a paper committing myself legally with the AAPB and in the FDA email I received, is specified below:

This communication is intended for the exclusive use of the recipient(s) named in this correspondence. It may contain information that is protected, privileged, or confidential, and it should not be modified. It may not be disseminated, distributed, reproduced, or copied to persons not authorized to receive such information.

So I'm going to assume that I'm not allowed to show you a copy of the email I received.

What I can do, however, is to provide you with the text of my email and the email address to which I sent it, so that you can also do the same. I exchanged two letters with the FDA and got a response in both cases within 24 hours. They are more efficient than some French administrations.....

I have sent an e-mail to the Industry and Consumer Education Division whose e-mail address is on this page and sent this text :

Information about NeurOptimal device (by Zengar)

Hello,

I am looking for information about the NeurOptimal material (https://neuroptimal.com) of the company Zengar. It would have been evaluated by the FDA as a relaxation device.

Could you give me a link to check if the FDA has actually evaluated the NeurOptimal and what are your conclusions? In addition, is it an assessment of its effectiveness, or simply a statement of its safety?

Thank you,

Sincerely,

The answer I received is consistent with my research: I could not find any information about the NeurOptimal device in any of our public databases on medical devices, including the Registration and List database. So it's no surprise, NeurOptimal is not a medical device and the FDA only manages that.

The person suggests that I submit a Freedom of Information request, but since this request is not free, I will skip my turn.

What I suggest in my articles is that you look at the evidence and discuss it. I have brought some elements comparing NeurOptimal's statements with the reality of the FDA, it is up to you to make your own opinion, now.

But from my point of view, NeurOptimal is -at best- relaxation. Take meditation classes, a good book where you can get a massage in a spa. The price will be lower and you will be just as relaxed ;-)

Neurofeedback is a therapeutic practice (NeurOptimal is not)

This is the second big piece, NeurOptimal recognizes the therapeutic benefits of Neurofeedback. "Therapeutic" refers to a "part of medicine that deals with the means -medicinal, surgical or other- to cure or relieve diseases" (Larousse). So it's a word backed by medicine, based on science. If in France, Neurofeedback is not recognized as medicine (we do not treat, we do not establish a diagnosis and we do not practice medicine), no doubt that in view of the progress of scientific research, this practice will gain its letters of nobility and I hope that one day, diplomas / training will be imposed to practice Neurofeedback. If only to protect the patient, or even to allow the reimbursement -even partial- of training by Neurofeedback.

In contrast, NeurOptimal is presented as a practice of "well-being". When people talk to me about well-being, I think of a person lying down with two slices of cucumber on their face with someone massaging her. Or, to me in the sauna, to wonder how I can survive at 90°C in an ultra-poor water atmosphere. And to tell me that I would have to try whole body cryotherapy at -145°C (by the way, it's a real medical practice in the treatment of chronic pain, so relaxing), to see what it's like to live a 235°C delta temperature. Relaxation is a bit like that for me. You have a good time, you relax, you're more rested on the way out. But if you were ADD at the entrance, you are ADD at the exit. The same goes for epileptics.

So it's great, I'm going to stop receiving insulting emails telling myself that I'm only talking crap about the NeurOptimal. Finally, I touch wood and cross my fingers.

NeurOptimal is "Dynamical Neurofeedback"

I have regained the trademark registration for the "Dynamical Neurofeedback". This is not new, it dates from 2011 and Zengar is kind because he specifies that he does not claim the exclusive use of the word "Neurofeedback". We didn't get far from the disaster!

So at the limit, I'd tell you, why not. Zengar is the only entity to speak of "dynamical neurofeedback" and "linear neurofeedback". He boasts of being the "first dynamical neurofeedback", but well, since it's the only one, it's easy. Crazy theories on the net, there are thousands of them.

In general, when I start talking to these people, I end up being insulted and called a scientist who is involved in a global plot where scientists would try to discredit these "innovative" theories. The person who doesn't speak English and who has never read a scientific article in his life (but he thinks he has relevant information for scientists, while he hasn't even read their writings), duh... and he wrote a book. As I was saying here, books are not proof of quality.

Again, all I'm suggesting to you, in these articles or when I'm talking to you, is to look at the evidence and discuss it. Proof is an experiment under controlled conditions, which can be analyzed objectively. That's not what anyone says, even if they're a scientist. It is an argument of authority, a rhetorical figure of manipulation.

In this example, between the theory largely denied by science (electromagnetism and DNA), the conspiracy approach (the dogmas of science are false), the absence of proof of what it claims, the big pharma conspiracy, or the non-evidence-based method of knowledge.... it was a winning third.

You know, I'm a nice guy, but I'm also direct and honest. I have no time to waste, no time to waste you. If you want to be credible: bring evidence. Read the scientific studies. Without it, you'll be full of shit no matter what, honestly.......

Despite everything, this time the person remained quite polite. I wish him to continue working, using science to refine what is currently an opinion, fed by fake news. Maybe not everything is good to throw away in the 200 pages of his book.

Even if this is an extreme case, well......

In the subject we are interested in, we are facing Zengar who sells a machine that is based on a concept not verified by science (because they do not communicate on it, easy, impossible to build proofs for or against) and who is convinced to save the world. You see the parallel with the previous case?

There is still a little something that bothers me about this notion of "dynamical neurofeedback". You know, it's like the French expression "homeopathic vaccine".

In one case, we have the vaccine, which is an extraordinary scientific breakthrough that has saved and continues to save millions of lives every year. On the other hand, we have a "homeopathic vaccine" that is only a sugar cube. There is therefore an extremely precise scientific term, with another invented word, that completely changes the meaning of the entire expression. And frankly, if it's not to mislead non-scientists, I don't know what it can be. For me, it is really intellectual dishonesty to use this kind of argumentative practice. NeurOptimal is not based on the principles of Neurofeedback, it is not Neurofeedback, why then insist on using this word in their communication if not to try to confuse people and try to benefit from the clinical effectiveness of Neurofeedback?

And besides, I went through NeurOptimal's communication a little bit and the confusion is still there today, skilfully maintained, as we can see with these very recent examples from NeurOptimal's Twitter page. In other words, hashtag #Neurofeedback is used extensively, even though it is no longer supposed to be.

Conclusion

One thing to keep in mind: beware of corporate marketing. Confront their allegations with reality. Words have a meaning, especially in marketing where it is their job. If you are told that a product has been "evaluated", ask yourself:

• was it the non-hazardousness that was assessed?
  
• is it the benefits provided?
  
• is it the scientific evidence?
  
• is it just the marketing speech?
  

In this case, I have the impression that it is simply the speech.......

During the writing of this article, I was contacted by a person, who was looking for advice, because she did not want to buy her "machine" at the Neurofeedback Training Institute where she had followed the training. It took me a few emails and a little insistence to get this person to admit that his "neurofeedback training" had been done at Zengar and that she was therefore absolutely not trained in Neurofeeback, but only in the use of NeurOptimal. She herself being convinced that she is really trained in Neurofeedback.

It's sad and I feel sorry for this person. As I said in a previous article, in general, people who practice NeurOptimal really want to help, they were just badly advised.

To conclude this article, I suppose, if I really wanted to be picky, I would publish a screenshot of the home page of the website of this person who writes in black and white "today we must absolutely dissociate Neurofeedback, which is a therapeutic practice, from dynamical Neurofeedback, which only concerns NeurOptimal®, a "well-being" practice".

Whoups....