http://www.neurotechinternational.com/investor-centre/faqs
How does it work?
Mente Autism uses unique and award-winning technology to help relax the minds of children with ASD, enabling them to better focus and engage positively with their environment.
The neurofeedback system in Mente Autism takes clinical grade technology and brings this into safe home application. The device reads the user’s brain activity to identify and suppress abnormally high brainwaves that are typically found in children on the autism spectrum, by creating personalized auditory stimulation to reduce unwanted signals. This can be compared to noise-reduction headphones, which create counter-noise to eliminate undesirable external noise. The reduction in the user’s brainwaves via this daily therapy helps relax the user’s mind, which in turn brings about enhanced concentration and communication.
What certifications have been received for the Mente device?
Mente 2, the predecessor to Mente Autism, has received CE Marking and is FDA listed, while Neurotech subsidiary AAT Medical is ISO certified. Neurotech expects to receive CE Marking for Mente Autism in the third quarter of 2016.
http://www.ce-marking.com/medical-devices-class-IIa.html
and
However, read
http://www.ce-marking.com/medical-devices.html#isitaMDD
A Medical Device (MD)
is defined in Directive (93/42/EEC) as: Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of :
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted by such means.
ewwwwww flowcharts (Mente Autism is classified as a Class IIa medical device)
https://en.wikipedia.org/wiki/Alpha_wave#Biofeedback_training
https://en.wikipedia.org/wiki/Neurofeedback
Just some info on biofeedback and alpha waves
http://www.brainstimjrnl.com/article/S1935-861X(15)00566-5/abstract (This is the actual research they used to gain CE accreditation of their device, published mar/apr 2015)
The research deals with real-time brain stimulation in the form of a sonified neurofeedback therapy derived from a clinically comparable portable, 4-channel EEG system. The therapy aims to provide an effective management treatment for Autism Spectrum Disorder (ASD). ASD is characterized with a high level of delta electroencephalographic waveform levels, while alpha and beta prove to be present at lower levels especially in the frontal-temporal regions.
https://www.esciencecentral.org/jou...5.1000133.pdf?aid=18913#.VHtwe-zNxAc.facebook (This is their initial eveluation of their product, published sep 2013)
Abstract
A novel sonified Neurofeedback management therapy for children diagnosed with Autism Spectrum Disorder (ASD) is explored and tested. ASD is a condition in children which effects their social interaction, language and communication and behaviours. Literature suggests that people diagnosed with ASD tend to have higher levels of Delta (δ) waves and less levels of Alpha (α) and Beta (β) waves in their brain activity. This paper studies how the use of sonified Neurofeedback produced by a two channel EEG device headband and the Brain Music System (BMS), can successfully suppress the δ waves while at the same time promote α and β waves. The two channel EEG device headband records EEG activity and the BMS converts the EEG activity into sonified binaural signals feeding them back to the user. Results recorded showed a relevant δ wave suppression clearly indicating that children subjected to this study made significant progress in managing symptoms associated with ASD. This was also confirmed by feedback from the parents of the respective subjects.
Conclusion: Correct, this is just a portable EEG machine, essentially using brainwave monitoring and music to adjust brainwaves themselves. From my understanding they have a test they can conduct to see whether the child is receptive to mente and 70% of children have been receptive thus far.
Here is NTI's research page
http://www.mentetech.com/about-us/published-research/
Hear are the facts, if it doesnt work can they gain CE IIa approval, no? However, studies have shown that it does and therefore they can market it. Do they have a large enough data set or equivalence study for FDA approval, no, therefore they cannot market it in the US, however they have an equivalence study currently underway.
@uz3r As for the points of, hey my SO says this or that... you should have no reason not to trust their experiences at work. However, like all medical approvals larger studies are conducted so a greater range of data can be relied upon. Even after a drug or device has been approved, it just moves into post approval and they still collect data on it. Should you be skeptical of scientific research? It all depends what type of study it was, what control points they have used, or if it has been verified by peers within and outside of the research group. As a science grad myself (microbiology, biochemistry, molecular biology majors), I trust scientific rigor, even when its not in my field. Why? because I trust the process, for a easy example of this. I believe climate change is real, why? because climate scientists and numerous amounts of research say so, indeed, they are the professionals in that area, that is why I trust them. This is why I dont understand why people listen to a politician debate whether it is real or not, rather than say, the experts in the field... politicans, however, they are not experts in that area, they are policy creators and sometimes deletors
So, trust your SO, it is her experiences, however, even she might want to have a read and update her own understanding of ASD. Don't get disheartened by others, read into the science, google around more, have a glass of wine and chat about it. Keep posting, just read the science.
point 1. You said that you couldn't find any info on the net about evidence that ASD kids have different resting brainwaves to say a normal child. I'm not sure what you googled, but I found a shiteload.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3847481/ (3rd link in google, I would also encourage you to search for information on ncbi, it is probably the most common area you may find human biological related reearch)
point 2. You also stated that therapy would only improve the child ability in communication, attention span, etc. You are completely right, you SO, won't be out of a job any time soon. I would imagine that this device instead helps make therapy sessions easier and possibly more effective and possibly improvements would be seen more efficiently than before.
point 3. NTI owns ATT. So they did all the research together as ATT, then created NTI to use that research, create an effective device, and float on the market to CR.
As for your point on would a child wear the headband. Obviously, I think a headband is easier for a child with ASD to wear than stay for them to put on shoes. Seems like a good device for them to me? or maybe the best possibility that this is the least restrictive device for someone with ASD.
And you are correct, there are numerous scam devices with ASD or crazy cures with no scientific backing. Unfortunately, they are allowed to sell there crap with no remorse or regulatory approval. They are just unproven medical devices, or "drugs" (friggin homeopathy). Why are they allowed on the market? if they cause no harm and "may help" then it doesnt worry regulators, as soon as they state that they treat something, then its a regulatory issue and they need approval.
Sorry if I seemed like an internet asshat, not intentional. Keep reading, all the info is on the internet.
Got more today, ave trade today @ .345, cheers!
DYOR
(20min delay)
