For those closely following the development of Peter Tass' Stanford glove for treating PD, a potential new milestone in the development might have been reached last week. A patent was granted to Peter Tass last week on October 12.
U.S. Patent # US-20230321436-A1, titled MEDICAL DEVICE FOR STIMULATING NEURONS OF A PATIENT TO SUPPRESS A PATHOLOGICALLY SYNCHRONOUS ACTIVITY THEREOF (all caps are theirs not mine). I've only skimmed it but the link to download the PDF is here: image-ppubs.uspto.gov/dirse...
It's been my hypothesis that the hold up on further clinical trials of the glove that are needed to get FDA approval, have been on hold waiting for a patent to secure their IP. Hoping that this is a signal that trials may soon be launching. Fingers crossed.
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Neurosmith
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I too only took a look. The use of the term “pathologically” confuses me, even if we are talking about a patent.
I believe that it is not easy to demonstrate, without a doubt to the FDA, the causal relationship of the treatment to the disease, because the instrument must do what it says it will do and demonstrate it by the scientific examination.
There may be a problem of standardization of the instrument on a larger double-blind trial. As every glove maker knows, it's difficult to make two of the same, let alone more than 200.
Let's hope there will be results soon which in the end is what counts.
Frankly, variation in the instrument can be taken care of and should meet the standards as related to the electrical/electronic industry. I am sure they will do statistical repeatability and reproducibility tests on the sample sizes ( though small) before conducting the clinical trials.
The bigger question is, how wide the spectrum of response is going to be about how the patients will respond ? - something that Peter Tass and his team will not be able to control.
Proving to the FDA that all devices provide the same standardized treatment for a double-blind study is not that simple, the brain is not simply electronics but biology. In addition to building the instruments as identical as possible, it is necessary to have a calibration system , initial set-up and control system, which is what the addition of the “feedback” system is for.
If you can calibrate them in the same way you can demonstrate that they all provide the same treatment.
Then we rightly need to see the results that is what counts. Not easy, I wouldn't want to be in Tass' shoes .Let's hope !
Not easy. I have only skimmed. It needs more time. Hopefully, if Neurosmith is correct, Peter Tass will be along to explain how they are developing the new glove.
It goes on and on about the "clock signal". I thought at first this was a new feature - a different method of operation, like adding re-clocking to a DAC, but I think it may be an attempt to sweep up each and every device in this field , by referring to anything which offers a therapy using a pattern, but it also probably references some sort of feedback mechanism. The frequency of the Tass patterns for PD are based around the 0-30Hz patterns typically found in PD brains, and the frequency of the therapy pattern is geared to that. The new glove may monitor the patients brain pattern frequency and tailor the therapeutic pattern frequency to that.
It's difficult to deduce any specific features of the next-generation gloves from this patent, which, for legal reasons, tries to cover the coordinated reset field as widely as possible (including feedback from intrisic and external signals of the wearer, plus allowing for a very wide range of stimulation regimes and patterns and input targets).
What could be the next practical steps? Peter Tass has developed the framework of coordinated reset for >20 years. His theoretical understanding of the aspects and parameters that are involved in the different stimulation regimes is probably unmatched in the world. Nonetheless, that does not mean that one could build an optimally effective device directly from the theoretical concepts. Because of the vagaries of the brain, a lot of trial and error is involved in defining the best parameter settings for such a device, much more than the handful of experiments that have happened so far. In that respect, the wide-ranging patent cover could be rather hampering the experimental efforts of outside groups, because they may have a scientific or medical motivation, but no financial incentive for developing a better device. In fact, I am not aware of any outside group studying vCR experimentally at the moment. (I don't think the clinical trials by Synergic really count.)
So I keep my fingers crossed that Peter Tass himself has managed to obtain financial backing or decent funding that will allow his group to substantially expand their experimental efforts. -- What remains is the tinkering by the DIY glove community, but I don't think that will be systematic enough to lead to fundamental improvements of the gloves.
Sergey Brin is helping to fund Dr. Peter Tass with the gloves. forbes.com/sites/kerryadola... Based on his webinars, it seems that his new industry partner is now Boston Scientific instead of Synergic.
The relevant passage from the article: “…, Brin’s philanthropic team also makes some donations to other researchers, including those working on projects that could serve Parkinson’s patients sooner. At Stanford University, Dr. Peter Tass, a neurosurgery professor, has developed gloves that deliver a stimulus to the fingertips and in a pilot study reversed Parkinson’s symptoms in some patients. One man with Parkinson’s who needed a cane to walk wore the gloves and was able to walk normally after just hours; he soon recovered his sense of smell and taste, and months later ran his first marathon. Brin’s team is talking to a potential partner to help Tass get his invention to market faster.“
Aside from Kanwar, Doug Bland was another participant who ran a marathon after having the gloves treatment. He is featured on the video starting at 2:40 abcnews.go.com/Health/video...
Boston look impressive. They already make scanners and dbs systems. Together with a watertight patent I would have thought synergic have nowhere to go and such trials as they are carrying out are a waste of time.As for the best parameters I think the new gloves will configure the treatment to measured brain scans.
I think Tass has a fair idea about what works better. The preface to the only clinical trial they have published referenced the first human clinical trial which had disappointing results due to inappropriate parameters.
Fortunately, 'brain scans' means EEG, or ideally MEG, which are easier to acquire than fMRI. (fMRI does not have the temporal resolution to identify patterns of abnormal synchronization, and EEG is noisy, therefore MEG would be the ideal approach, even though it requires expensive equipment.) Unfortunately, putting M/EEG scans into the loop is still much more of an effort that sending patients home with a pair of gloves for 4 months. That's probably the reason why, so far, there is only the one pre-post 3 months EEG figure at the group level.
A straightforward approach would be to start with the acute effects and record M/EEG before, throughout and after a glove session. It would be a massive amount of data to analyse but likely quite informative. Of course, the brain signals would then also have to be related to behavioral measures - all feasible, but quite an empirical effort.
Another possible way to provide calibrated treatments via the gloves is to provide the user with medical-grade wearable devices to measure gait, balance, tremor, etc. This could be supplemented by a questionnaire on an app providing questions on non-motor issues such as sleep quality, hallucinations, constipation, etc. The results could then be used to provide a more customized treatment program via the next generation of gloves.
If someone really wanted to work on this they could just move forward, obtain good clinical results, and then negotiate a royalty from the patent holder if a judge says they are infringing. This happens a lot. Who really owned CRISPR when the mad race for gene editing cures first started. Who owned cellphone technology. The reality is that if you start a medical device company the net margin may only be 8% (after years of capital investment), so why not charge a 5% royalty on the gross and do none of the hard work. If you look at the aug 2023 patent there are 20 use cases from tinnitus to irritable bowel syndrome. I think Peter Tass would be thrilled for others to go after these use cases and pay him a royalty
The other thing is 99% of patents are not challenged. A large percentage of those that are challenged are found to be invalid. The Indian generic Pharma industry has a saying that US patents are not worth the paper they are written on
Great to hear. We are now seeing Dr Tass technology on the road towards production. Considering all his dedication it's great to see a possibility of future reward and an award to him and his team. But wonder how long until the availability and FDA approval?
Again: Let's all consider the political arena. Since PD is increasing with every generation eventually considering the damage it could cause the economic community, as in more disability, more medications cost, less people to participant in the workforce. Perhaps with the relationship of the environmental factors, unfortunately the young healthy folks working today as we speak may end up debilitated in their future from PD. I am also puzzled by this "Right To Try" law ? Does that only apply to medications and Cancer or terminal conditions? How constitutional is it if you made it available for only certain conditions?.
In general I'm not a huge fan of trying things in Phase I. I think the FDA generally gets things right by requiring two successful trials on primary endpoints that are relevant to patients and clinicians and an extensive analysis of adverse events. I appreciate the role of the advisory committee and the public briefing documents before a final decision is made.
Put another way I'm glad I did not try experimental drugs for ASIOs, for checkpoint inhibitor combo products by NKTR for cancers that showed early promise, for complement inhibitors for IgA nephropathy, and the list goes on and on of products that showed early promise (esp in cancer) but ultimately failed miserably in late stage trials, in some case with serious side effects.
Well, Peter Tass has mentioned that he moved to the US and Stanford (around 2017) to speed up the commercial development of his research. He had previously started a company in Germany to develop devices for coordinated reset in the context of tinnitus which I think has folded in the meantime.
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