Flux Health Forum

Hair Loss Pilot Study 2023

my hair loss from showering and or using gel to comb my hair has consistently been low compared to before using the hat. it was concerning to see how much hair I’d see on my hands by just cleaning or grooming my hair. i can’t say that I’ve noticed volume or growth more than usual, but I’m happy the reduction in hair loss is noticable and remained so.

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@OptimalHealth, purely anecdotally, this is exactly what I hear from the people doing the research when they try the system for themselves (not as subjects in their formal study).

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Hi Bob,
I own an anti-aging clinic in Hanoi and a factory in China where we manufacture orthopedic braces. I have a residence in Vietnam and China, as well as Texas. We use light therapy which includes top and bottom full coverage of the body, hat and face/neck mask as well as a nasal cannula which we developed. I had them custom made with 4 wavelengths whereas everything else I saw is only two. 620nm, 670nm, 760nm, 830nm.
I know I am late to the game but I am very interested in the PEMF hat, especially if it is combined with light therapy.
I noted you mentioned the high cost of manufacturing prototypes. I wonder if I might be of assistance. I have been living in Asia over 30 years. 21 years in China. I am confident I can get prototypes made for a reasonable cost.
I own the M1 which I bought last year.
Thanks,
David

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Hi David,
I am working closely with the company right now that wants to bring the ICES-PEMF hat to the global market. It is a long, complex negotiation, and eventually will involve subcontracts for manufacturing. They want to try to do as much in-house manufacturing as possible, but they may need to seek outside assembly of some of the components. If that ends up being the case, I may need to speak to you about it. Thanks.

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Looking forward to hearing from you.
I believe you said the company is in Bangkok.
Bangkok is just a 2-hours flight away.
I often go there.
So, if you need an advocate to check in on them, let me know.
I’d love to have a hand in getting a product like that to market.
I’d want to use them in my clinic.
Also I could help keep them honest in their costing by giving comparative cost to manufacture the hat.

If the sample hats become available then I would like to buy one.
Regards,
David

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Hi David,
I just met with the engineering and regulatory staff of the company that will make the products. They are all located in Portugal and Spain (one in Germany too I think).

The initial plan is to enlist about 10 clinics to test prototypes, starting in about 2 months (approximately), so I could put your name in the hat as a potential clinic for testing if you like. They plan to do a full set of safety and efficacy tests with a control group in the study as well, so it is a pretty big deal. They also do quantitative assessment of the effects on hair using clinical imaging and assessment standards acceptable to the US FDA.

At this point I do not think I could sell individual hat inserts because of the product controls that need to be applied going forward.

So, let me know if you would be interested in being one of about 10 test clinics

Bob

Absolutely interested.
Thanks,
David

does this mean that the hats can possibly be going up for trials in the US so that they can be used/sold in the US as an approved medical wearable Device?

Hi Bob,
I tried to place an order for a C5 and coils however the system won’t accept my card which is on our bank in Cambodia.
Is there another way to pay for it using the overseas card?
It is such a pain to make payments when I use my US credit card.
Thanks,
David

I have absolutely no Idea, sorry. I am not involved in sales in any way.
If I had this question, I would have to:
Contact support@micro-pulse.com

I think so, hopefully not too long from now, but things like this tend to follow unexpected trajectories.

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@Bob, Hi Dr. Dennis, I was able to purchase the hat, and had just a few questions please, sorry to be long-winded:

  1. Is there a suggested protocol/frequency/duration that is being studied or recommended as being optimal for follicle stimulation/hair growth? (I’m mid-50s male with receding hairline).

  2. I also have ADHD, and the usual executive function and working memory problems that accompany it, and from what I’ve read, disfunction in the PFC, particularly the right dorsolateral PFC, appears to be the primary culprit for these types of disorders. Similar to some others on this post, I am interested in killing two birds with this hat if possible. When the hat is worn in a normal way, with the bill facing front, how proximate are the anterior coils to the PFC, and how much coverage of the PFC (on average size adult head), would they provide?

  3. Given that this grey padding appears to buffer/increase the space between the coils and the scalp, AND the fact that there seems to be more coils in the hat, than say the normal dual-coils that I use with my M1, thereby dispersing the delivered PEMF energy over a greater area, could it be reasonable to postulate then that perhaps increasing the intensity would be optimal? So say for example someone normally keeps the coils at level 11 when applied to their scalp, could it be beneficial to run at maybe a 13 to 15 when using the hat?

  4. In large part due to my ADHD/ASD, it is difficult for me to be “self-aware”, and to have the patience and awareness to perform longitudinal studies on myself. Have you and/or any of your colleagues at UNC or corticalmetrics, studied the affects of ICES/PEMF on mitigating brain disfunctions, such as focus/attention/working memory, etc., along with researching optimal protocols, frequencies, montage, etc.?

  5. Regarding the Brain Gauge, what is the “recency” of its MOA and analysis? By that I mean, does it tend to measure “cumulative”, and “overall” brain state and health, vs more “transient” or “localized” states and conditions, say for example, when someone takes a pre and post Brain Gauge test accompanying an ICES session on a particular area of the scalp? Is there a directory of mental health practitioners using the Brain Gauge, searchable by city/state? Thank you for all you do!

I will answer each numbered question below:

1 - We have only run one pilot study, only using Omni-8 protocol, and outcomes seem positive.

2 - Don’t really know, sorry, but as with all PEMF that I am aware of, effects tend to go well beyond the exact location of coils.

3 - No, definitely not. More is usually not better, and one early finding of our pilot study is that we probably used too much intensity to get optimal effects.

4 - No, not at all, sorry. The only thing we looked at was mTBI + PEMF, and results were promising.

5a - Probably both: current as well as cumulative effects.

5b - no directory, but you could contact support@micro-pulse.com and ask if they would put you in touch with Dr. Tommerdahl to see if he would be able to discuss this topic.

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Hello Good Community,
As I work to help develop the ICES-PEMF hat into a product, one of my foremost considerations is of course safety. So it would be greatly helpful if you could report to me here, by reply to this post, if you or someone you loaned it to tried one of the prototypes that I made available last year, and if they had any kind of adverse reaction. If you did have an adverse reaction, please reply to this post, tell me what settings you used (intensity level), and how long and when you were using it when you experienced the adverse effects. Also, how severe was the effect, how long did it last, and any other details you would like to share.

We did not really get any reports of serious adverse reactions, and definitely nothing that lasted very long, but I want to be sure that we are aware of any possible adverse reaction.

Thanks in advance.

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Scientific progress being made…

If the above link does not work, try this link directly to preprints.org:

Bob, I have been a longtime happy customer of a C5, and I am eager to obtain a hat prototype for my mother who is rapidly losing function, including her ability to speak. I have seen the podcast where one of your customers helped his
Mother with Parkinson’s using IVES to n her head. So I have made a makeshift hat for her which keeps falling off of her head, but hope to obtain a C5 attachment that is more suited for purpose. I’ve read on this forum that the hat can work beyond the scalp!
Can you make any more hats? I’d be very grateful if I could eventually get my hands on one.

Thanks in advance for your reply,

Hi @lulu7,
Unfortunately I can not make any more hats, by legal contract, to with the company who has licensed the rights to make them for consumers.

This is not something I can realistically make anyway: each would cost me about $15,000 to make because making them by hand is extremely time and resource demanding. That is a tolerable cost of research prototypes, but definitely not consumer goods. They need to be mass produced for them to become available at a reasonable price.

For your immediate needs, I suggest you try using a C5 with a skull cap-type hat from amazon. You can sew or otherwise affix the coils inside or outside a cap that looks like this:

https://www.amazon.com/gp/product/B07B7DJS3T/ref=ppx_yo_dt_b_search_asin_title?ie=UTF8&psc=1

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Ok thanks for your response-I’ll tey the Amazon cap fix. Do you have any idea if and when they’d become available?

well, as an educated guess I would say 12 to 18 months, but even that is wishful thinking for the development of a new “complex” product.


And, as usual from chatterbox Bob :roll_eyes: , a lot more detail for those who would like to gain a sense for how challenging it is to try to bring a “complex” product to a global market:

“Complex” means that the product is not just a simple piece of plastic or a simple electronic device, like a flashlight for sale in an unregulated market. A therapeutic hat product using ICES-PEMF intended for sale in a global market as a regulated medical device is a “complex” product because all of the conditions at the beginning of this sentence, plus the integration of many different mechanical and electronic components, firmware/software, human compatibility considerations in the design, etc.

There are dozens or hundreds of people involved, a lot of money that can suddenly evaporate, major international regulatory hurdles, competing intellectual property, not to mention all of the known and unknown geopolitical instability across the globe that will have a massive and unpredictable impact on global supply chains.

Developing a new product is unlike anything a normal person is familiar with. To gain an intuitive sense for the difficulty and complexity, you can think of it like this:

Imagine you are planning a wedding. But…

The wedding is for many couples involving different people living on different continents who have never met each other before. And you are not quite sure how many couples there are getting married.

They all have different religions and different marriage traditions and taboos.

You have to feed everyone, but you don’t know what they eat, and you don’t know how many of them you need to feed.

Some of these people might already be married or have other hidden legal barriers.

The wedding will snap to a halt if any single one of the gifts does not arrive. The gifts are headed in at different times in different amounts addressed to different people from all corners of the globe.

A large number of different regulatory agencies require you to take detailed pictures of each stage of every wedding, from the time of proposal until the kids get sent off to college.

And you’re not quite sure what the laws and requirements are in each location where you are hosting this coordinated network of weddings.

Meanwhile, several other wedding planners are spying on you and are actively doing everything they can to steal your wedding guests and undermine the massive wedding plan that you are trying to organize.

And all you need to do is plan all of this, find the money, and hold it all together until it actually happens, which could be weeks, months, or years.

My best guess: allow 12 to 18 months, but do not hold your breath.

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Yikes. Ok, so the hats wil become available when they become available. Or not :grimacing:. Thanks for the explanation!