Bothersome thoughts on nti, page-18

I wonder
In terms of methodology of a double blind placebo test on a device as opposed to a drug and specifically in relation to such a broad spectrum disability as autism
1 How do you first secure a test group of similar range disability to draw a valid comparitive base?
2 How do you secure "independent" reviewers? I would think researchers in this area a rather "tight" group with perhaps a bias towards a successful mass marketing solution?
3 I have read the purported observations of patients reduced tantrums and like but have to ask if those applyingvthe treatment are basically let's for pleasantry say cajouling young patients to place the band on their heads (i.e something completely foreign to them) would this not have an immediate impact and long term impact to either quiet them or have them reject the treatment. I mean how do you measure that objectively...as compared to say putting a tight headand on their heads?

In other words how effective is a double blind placebo in these circumstances? Especially when you consider the level of midiagnoses in this area?

Suggest these issues be carefully considered. There is a very high motivation to create "miracle cures" based on monetary gains of certain interest groups. Trying to validate "quackery" for profit is not a new phenomena. One only has to look at the raging debate on various techniques in the field of pschology and psychiatry...indeed the very foundation of the DSV 5 e.g.

https://www.google.com.au/amp/s/www.theodysseyonline.com/criticisms-dsm-5.amp

And this is a fairly mild article compared to others as well as investigative documentaries that have been made over the years.

This is without even a direct critisicm of the Co itself.

Suggest those with a real conviction towards finding solutions for those impaired give cateful consideration to issues that contradict rather than take an overly sunny disposition towards the methodology of double random placebo trials in this context. Think it's different for drug trials in terms of far more rigorous phase trialing and time duration and cost to get spproval as oppossed to non invasive devices...much much different. Anyone here have a clue as to ehat Device category this falls into from 1 to 4 on yhe FDA categories. Suspect it's likely a 3? Maybe a 2? If do also need to consider barrier to entry issues I would think.

https://www.google.com.au/url?sa=t&...jDc8QFghZMAc&usg=AOvVaw1JLMCtw_qSnVNd3Ca_wQDD