Experimental Tongue Therapy Helps Restore Brain Function

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby NHE » Sat Sep 08, 2018 6:26 pm

zen2010 wrote:
NHE wrote:The following website claims that the average time for FDA 510(k) clearance is around 6 months.
https://www.emergobyul.com/resources/re ... s-research


From the above website: "The 15,000+ device clearances we analyzed in March 2017"

15,000+ in a month?!?!?
Seriously?That's 500+ per day!

They were just looking at the clearances and not the actual devices. It's likely that they just did an analysis based off a spreadsheet and did some data plots or other data summaries.

Did you read their report on 510(k) clearance?

https://www.emergogroup.com/sites/defau ... s-2017.pdf
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby zen2010 » Mon Sep 10, 2018 11:58 pm

Hi NHE,

OK, I misunderstood.
After reading the report it's more clear

In 2016 they gave the green light to around 8 requests/day.

Only 8, seriously?!?
lol

Just kidding:)
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby zen2010 » Tue Sep 11, 2018 1:24 pm

Bad news for us (MSers)

Here is a message I received from Helius (I sent few questions...):

Hello ***,

Thank you for your interest in Helius Medical Technologies and the PoNS (Portable Neuromodulation Stimulator) device. The PoNS is an experimental device which is going through the clinical trial development process.

Helius submitted our request for clearance with the FDA and Health Canada with the hope of receiving approval for the device by the end of the year.

The FDA will limit the use of the device to people with TBI at first because that is the study we have submitted for clearance. For use in other neurological conditions, other studies will need to be done. Due to the highly regulated industry that we are in, there are several details that we are not able to finalize until the device is cleared.

Information such as how and where to purchase the device will be announced as soon as they are available as well as additional clinical trials for other uses of the device.

To ensure you are always up to date with Helius, we encourage you to sign up for our newsletter. You can do so by visiting our website at http://heliusmedical.com/index.php/cont ... ny-updates.

Kind regards,
Lori
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby zen2010 » Tue Sep 11, 2018 1:49 pm

After reading again Lori's answer, I am a bit confused.

I mentionned in my information request that I had ms. What I understand from Lori's answer is that the PoNS will be first available to people with TBI (Traumatic Brain Injuries), not other pathologies.

BUT...TBI can sometimes be part of MS...

So I guess MSers who have only spinal lesions won't be able to use the PoNS before completion of other studies .
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby NHE » Tue Sep 11, 2018 10:46 pm

zen2010 wrote:The FDA will limit the use of the device to people with TBI at first because that is the study we have submitted for clearance. For use in other neurological conditions, other studies will need to be done. Due to the highly regulated industry that we are in, there are several details that we are not able to finalize until the device is cleared.

They ran a small trial in MS. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5466147/ There were just 7 treated patients and 7 controls. It seems like they might need a larger trial for FDA approval. It does bring up the question if off label device prescriptions work the same way as off label medicine prescriptions, i.e., it's up to an individual doctor to prescribe the device?
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby zen2010 » Wed Sep 12, 2018 7:02 am

Hi,

when I suggested to Helius people that "TBI (Traumatic Brain Injury) was also part of Multiple Sclerosis (Extreme fatigue, cognitive issues, cerebellum lesions etc…) + it would be up to doctors to prescribe the device + it would be really unfair to suffer from TBI without being able to benefit from the PoNS cause we are labelled MS…"

I received the following answer "In order to qualify for an “Early Access Program” there must be a serious or life-threatening disease or condition as defined by FDA. In the absence of a serious or life- threatening condition, the patient has time to wait for definitive data to emerge regarding safety and efficacy. Due to the guidelines provided by FDA and our regulatory attorneys, we believe that our technology does not qualify for this program."

So that means:
-We can forget about this device at the moment
-MS will never get qualified for an “Early Access Program”
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby NHE » Wed Sep 12, 2018 3:31 pm

zen2010 wrote:when I suggested to Helius people that "TBI (Traumatic Brain Injury) was also part of Multiple Sclerosis (Extreme fatigue, cognitive issues, cerebellum lesions etc…) + it would be up to doctors to prescribe the device + it would be really unfair to suffer from TBI without being able to benefit from the PoNS cause we are labelled MS…"

I received the following answer "In order to qualify for an “Early Access Program” there must be a serious or life-threatening disease or condition as defined by FDA. In the absence of a serious or life- threatening condition, the patient has time to wait for definitive data to emerge regarding safety and efficacy. Due to the guidelines provided by FDA and our regulatory attorneys, we believe that our technology does not qualify for this program."

So that means:
-We can forget about this device at the moment
-MS will never get qualified for an “Early Access Program”

Helius also appears to be saying that they, as well as the FDA, don't think MS is serious. WTF! :wtf:
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby NHE » Fri Sep 14, 2018 12:42 am

NHE wrote:
zen2010 wrote:The FDA will limit the use of the device to people with TBI at first because that is the study we have submitted for clearance. For use in other neurological conditions, other studies will need to be done. Due to the highly regulated industry that we are in, there are several details that we are not able to finalize until the device is cleared.

They ran a small trial in MS. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5466147/ There were just 7 treated patients and 7 controls. It seems like they might need a larger trial for FDA approval. It does bring up the question if off label device prescriptions work the same way as off label medicine prescriptions, i.e., it's up to an individual doctor to prescribe the device?

Here's another small study with MS patients from 2014. There were 10 treated and 10 controls. The results were positive for improving gait in MS patients.

https://jneuroengrehab.biomedcentral.co ... 0003-11-79

Full free text.
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby zen2010 » Fri Sep 14, 2018 6:58 am

NHE wrote:Here's another small study with MS patients from 2014.



2014....
We're almost in 2019 and no phase2 study was performed :cry:
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