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See my post on Norman Doidge's book "The Brain's Way of Healing"zen2010 wrote:Hello,
Have you heard about this?
Cheers
haven't read full text but would be interesting to see whether or how they attempt to deal with confounders"...
•CN-NINM was used during physiotherapy for the rehabilitation of gait and balance.
•In this patient, gait and balance improved in all tests and without adverse effects.
•This is the first case other than in MS and stroke using CN-NINM for rehabilitation
...To deliver the non-invasive neuromodulation we used a Portable Neuromodulation Stimulation (PoNS™) device (Helius Medical Technologies)"
hmm not fishy design at all"The objective of this paper is to study effects of noninvasive tongue stimulation using the Portable Neuromodulation Stimulator (PoNS™) combined with intensive cognitive and physical rehabilitation on working memory, gait, balance and concomitant changes in the brain.
................................active............sham
MS duration (years)........11.2.............22.3
Age range (yrs)...........28–61..........38–62
Disease duration for the sham group is significantly longer (F = 5.109, p ≤ 0.045)....
Active group members adjusted the PoNS stimulus until felt as a moderately intense tingling sensation. The sham device required no stimulus adjustment...
key point wrt neuroplasticity: "age distribution of active group significantly wider/younger"removing trademarked terms from the scholar search:...The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was sponsored by Helius Medical Technologies Inc under a contract with McGill University and the Clinical Research Unit at the Montreal Neurological Institute."
not sure what i think about the sham"Both groups completed a 14-week intervention program using a standardized combination of exercise and a device that provided electrical stimulation to the tongue. Those in the active group received electrical stimulation on the tongue that they could perceive. Those in the control group used a device that did not provide a physiologically significant stimulus and was not perceivable."
yeah i think i would know pretty quickly which arm of the study i was in..."From our previous research, we have observed that with experience, subjects set the intensity level at between 50 and 80% of the maximum dynamic range of sensation [43, 44, 45, 46, 47, 48, 50, 51, 52]. If subjects could not feel it, they were reassured that they were still receiving stimulation but it was below their individual threshold of perception."
"All authors are affiliated with the University of Wisconsin, Madison.
MT teaches in the Department of Biomedical Engineering at the University of Wisconsin, Madison. He is a co-inventor of the PoNS device and is a contributor to the development of the CN-NINM training method. YD is a co-inventor of the PoNS device and is a major contributor to the development of the CN-NINM training method. KK is an expert in electrotactile stimulation and a co-inventor of the PoNS device."
NEWTOWN, Pa., Sept. 04, 2018 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that the Company has submitted a request to the U.S. Food and Drug Administration (“FDA”) for de novo classification and 510(k) clearance of the Portable Neuromodulation Stimulator (PoNS™) device.
“Helius is excited to announce the submission of our request for de novo classification and 501(k) clearance of the PoNS device for the treatment of chronic balance deficit due to mild- to moderate-traumatic brain injury,” said Philippe Deschamps, Helius’ President, CEO and Chairman. “This important milestone is the result of many years of hard work from the Helius team, and it brings us one step closer to making our novel PoNS Treatment available for U.S. patients who suffer from the potentially disabling effects of TBI-related chronic balance disorder.”
The Company’s request for de novo classification and 510(k) clearance is supported by clinical data from two double-blind, randomized, controlled trials demonstrating the PoNS device’s safety and efficacy, with combined enrollment of 163 patients. It is also informed by feedback provided by FDA during pre-submission meetings that focused on the Company’s trial designs, clinical data and design verification testing.
Mr. Deschamps continued: “Looking ahead, the Company is focused on laying the groundwork for the commercial launch of our PoNS Treatment following FDA clearance and pursuing regulatory clearances in Canada, Australia, Europe.”
What is the De Novo Classification Process?NHE wrote:Helius Medical Technologies Submits Request for FDA 510(k) Clearance of the PoNS™ Device
September 04, 2018: 07:00 AM ET
https://money.cnn.com/news/newsfeeds/ar ... 372059.htm
NEWTOWN, Pa., Sept. 04, 2018 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that the Company has submitted a request to the U.S. Food and Drug Administration (“FDA”) for de novo classification and 510(k) clearance of the Portable Neuromodulation Stimulator (PoNS™) device.
510(k) ClearanceThe De Novo classification process, also known as “Evaluation of Automatic Class III Designation,” is a device classification process that allows FDA to classify new devices that are not equivalent to an existing Class I or Class II device and would otherwise be automatically classified as a Class III device [Section 513(f)(1 ) of the FD&C Act)], regardless of the device risks or the ability to demonstrate general or special controls.
Well that's interesting. De novo classification seems to be in conflict with 510(k) clearance. One says there are no similar products on the market and the other says there are. I have read that the PoNS device is the first of it's type. How does 510(k) clearance apply then?If a company can prove its device is “substantially equivalent” to another already on the market, it can forego clinical trials and testing, saving time and money. Unlike the more rigorous PMA standard, which is to reasonably ensure safety and effectiveness, the 510(k) standard is to determine whether a device is substantially equivalent to a legally marketed device.
In other words, when the FDA clears a device through 510(k), it is not examining if the product is safe or effective for use in patients. It is just agreeing with the maker’s claim that the device is similar to another device already on the market.
Hi,NHE wrote:NHE wrote:Helius Medical Technologies Submits Request for FDA 510(k) Clearance of the PoNS™ Device
September 04, 2018: 07:00 AM ET
https://money.cnn.com/news/newsfeeds/ar ... 372059.htm
I suppose that they're trying to show that the new model is identical in function to the prototype that was used in the clinical trials though the prototype was never "on the market."NHE wrote:510(k) Clearance
https://www.drugwatch.com/fda/510k-clearance/
Well that's interesting. De novo classification seems to be in conflict with 510(k) clearance. One says there are no similar products on the market and the other says there are. I have read that the PoNS device is the first of it's type. How does 510(k) clearance apply then?If a company can prove its device is “substantially equivalent” to another already on the market, it can forego clinical trials and testing, saving time and money. Unlike the more rigorous PMA standard, which is to reasonably ensure safety and effectiveness, the 510(k) standard is to determine whether a device is substantially equivalent to a legally marketed device.
In other words, when the FDA clears a device through 510(k), it is not examining if the product is safe or effective for use in patients. It is just agreeing with the maker’s claim that the device is similar to another device already on the market.
Yes. To see the videos of the positive changes in people's walking is quite remarkable.zen2010 wrote:I don't really know what to think about this... I mean, this should be a very popular topic in the pwms community, but it's not.
The following website claims that the average time for FDA 510(k) clearance is around 6 months.zen2010 wrote:Do you know how long it takes for the FDA to decide whether a request is accepted or not?
In a nutshell, we may see the PoNS for retail sale in about 6 months if it's successful. Helius estimates the retail price for the PoNS at $2500.Examples of Class I devices include: elastic bandages, dental floss and enemas.
Class II devices include: condoms, pregnancy testing kits and powered wheelchairs.
Examples of Class III devices include: implantable pacemakers and breast implants.
From the above website: "The 15,000+ device clearances we analyzed in March 2017"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