I was sure someone had posted asking for details of progress with the clinical trials for the gloves developed by Peter Tass, but I cant find it now
Anyway, here it is clinicaltrials.gov/study/NC...
Expected start date : April 2025
Expected completion : October 2027
However, the "proof of concept" trial is "not yet recruiting" (15 aug 2024) clinicaltrials.gov/study/NC...
The trial by Synergic seems to have disappeared
it appears that the trial may only be open to early Parkinson patients
Inclusion Criteria:
Ages 18 and older
Idiopathic Parkinson's disease Hoehn and Yahr stage I
Fluent in English
Appropriate social support if required during an off state.
Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes.
Feels comfortable going off PD related medication during in person study visits
Lives in the United States
Hi, when I see you I can't help but, ask how you are and how your gloves are going? Happy mid-August.
I'm doing well thanks Fed. My gloves are victim of "if it ain't broke , don't fix it" so completion of amplitude modulation and the small exciter "mark 5" glove is still "tomorrow" but the gloves are working fine, and I am used to their clutziness.
I am still catching up work, and realise just how much time this project soaked up (productively) - not just the glove research and development but finding 2 2 hour sessions a day for 4 months.
I wouldn't want to be without them!
I'm happy Winnie, were you also able to reduce the medication? Thanks to your help, here in Tuscany, at a research institute, we are also trying to something similar to Tass gloves.
I'm intrigued about helping your research institute. Please keep me informed. Currently I have not reduced my medication, but that is because I am only using the gloves for maybe 2 hours a day, 3 or 4 times a week. I was using the gloves more before, and needed to cut my meds. But I am on fairly low meds anyway and tolerate them well, so I prefer to reduce glove time. It takes 20 seconds to take 2 sinemet but 4 hours to do 4 hours glove time.And it's not all about meds. Nor videos. I didn't get round to using the gloves for 4 days last week, due to one wire breaking, and choosing to tidy up a couple of other pods. This morning I got up early and did a proper 2 hours. Walking the dog, my left arm was swinging, my foot wasn't dragging, I could reach down to let a stone out of my sandel easily. But mostly, yesterday I felt shit and today I feel like a million dollars, and nobody thinks to measure that
Thanks Winnie for information. I'll definitely let you know about the developments.
I too have DIY gloves. In fact we have made 4 pairs, each one a little different than the other. Mostly we have worked on the ease of fit of the tactor / velcro / elastic finger pod.
I started using the gloves April 1, 2024 and saw a lot of improvements in the areas of smell, sleep, voice. ( but not balence and gait). After about 3 months almost inadvertently I reduced my meds. and I am now wearing the gloves "just" 2 hours per day.
But like you mentioned some days are great and some are very bad. This has me concerned so I appreciated your comments.
I raise this question for comment from you and any other reader:
Who with DIY gloves sees this variability in results?
I welcome your comments.
To be fair my fluctuations in well being broadly follow a pattern that if I fail to use the gloves I feel rubbish and if I make the effort to use them I feel much better.What sort of "tactor" are you using, and how would you describe the "volume" setting that you use?
I note that in common with many you get an improved sense of smell, but whilst I can sometimes smell things a bit this hasn't been an obvious glove related improvement.
Hi WinnieThePoo,
Sorry for the slow response. We had guests.
We are using the Buzzah! ( github.com/kriswilk/buzzah ) DIY glove design with LRAs. We have a printing machine so we were able to print the tactor housing. With respect to volume, our Health Unlocked friend , Neosmith who is helping us provided this info about our gloves.
FWIW, the Buzzah algorithm that you use for your gloves has parameters that you can edit to adjust the jitter, aka noisy or not, as well as the mirrored vs non-mirrored and several others. I believe you guys are using the default values which have the jitter set at 23.5%, which Tass mentioned using in a paper, and non-mirrored. I'm using the 23.5% jitter and mirrored.
Our tactor housing is attached with velcro and elastic strap. Ilike them tight.
I'll send some pictures tomorrow.
Report
Thanks for the reply. It would be interesting to see some sort of summary of user results - although it would probably be distorted by lack of participation by those not benefiting and losing interest.
Regarding intensity or volume, I was thinking in terms of a subjective assessment. I try to set my gloves, one finger at a time, at the minimum level I am aware of, or sometimes just a bit louder than that. Peter Tass research clearly points to the potential importance of that - because a low volume will reduce unwanted dispersion to adjacent mechanoreceptors. I think the graph illustrates the much reduced amplitude he believes to be key to improved results.
It is based on a signal which squashes and decompresses pacinian corpuscles in a small zone, by squashing them 0.5mm, and then from that fixed compression increasing and decreasing the compression by 0.035mm. There are 2 points about that. The first is 0.035mm is a tiny amount of movement. It's about 1/3 the thickness of regular photocopier paper.
The 2nd is that it relies on a "jack-hammer" tactor, not a rattling bean can. The 8mm contact needs to move in and out. Not stay in contact and be rattled from inside in an up and down fashion.
It may not matter, but there are lots of aspects of Tass published research, which implies it does.
Just to be clear, I don't think I experience your glove-related variations. As explained to me during the SPARK trial, I experience fluctuations in my underlying PD. But my glove fluctuations are simple. If I use the gloves I benefit. When I don't use them I suffer for it. It's that simple. Trying to reduce the time needed using them, and like any rigid habit broken, then not getting round to using them, or discovering a bit of dodgy soldering has resulted in a faulty glove, which I can't find time to mend, results in a substantial deterioration in my condition. Making the effort to use them, at least 2 hours a day, at least 5 days in 7, keeps me at my current best
It was interesting recently at a village fete meal, to discuss the gloves and my PD with strangers. It was interesting how adamant my wife was of the difference the gloves make. And it was interesting that at 7 years post-diagnosis, they all said they couldn't believe I had PD. Of course, partly this is the frustration that PD is not just about tremoring, stooping and shuffling, but I have to say I was feeling good .
Hi Taranto. I am one of those experiencing such pronounced variations in symptoms as I mentioned in an earlier reply healthunlocked.com/cure-par...
Hi,
thank you for reminding me of your prior response
I am slow in the mornings and don’t hit my stride until the afternoon.
I sleep great; much better than I ever did before. I think that’s why takes me so long to get going in the morning .
I too often stay up all night and go to bed around three in the morning
no question the gloves change things but not everything is better
The wider swing in the symptoms has been reported by some users of the DIY and hacked bhaptics gloves but I have never encountered any such reports among those who used the real Stanford gloves (even those in the Synergic trial). Maybe, we really need the real gloves to get optimum results.
Thank you for posting this. I don't see a sham control for this trial. Am I missing something? This trial won't be completed until late 2027. Without a control group, how does this advance the FDA approval process?
No - they are open label
It looks like subjects act as their own controls - so they undergo actual treatment and “sham” treatment during the study.
That's the Synergic trials - not the Stanford ones. I'm a bit puzzled why the Synergic trials still list as "recruiting" after all this time. The Stanford trials are just further and further away. I'm reminded of when a Spaniard tried to explain to an Irishman what "manana" meant. The Irishman commented "we just don't have anything to convey quite that sense of urgency..."
We could have a scenario in which Synergic has a successful properly controlled trial and they can't sell the device due to patent infringement. Meanwhile, Stanford holds the patent but are not conducting controlled trials that could lead to FDA approval.
I think Stanford cut a deal with Synergic and will allow Synergic to market the glove that they made for Peter (But no changes or upgrades)
This is from Synergic's newsletter:
The current planned device is being investigated as part of our clinical trial. The device
you see in these pictures will be the device commercially available if we are successful
with FDA clearance
Link to their newsletter;
synergicmed.com/storage/app...
Have not dug into what each of the two Synergic trials are. I jus follow the you tube updates from a participant.
Do they truly b live thar they will be completing thee trials by dear end? If successful what would you goes the timing to market would be?
Sorry! My mistake! I love the story!
The two Synergic trials are here:
clinicaltrials.gov/study/NC...
and here:
clinicaltrials.gov/study/NC...
They are still listing as "recruiting" which seems odd given they only needed 30 participants.
The expected primary completion for NCT05881460 keeps moving back, but is currently 29 September - which seems ambitious for a trial that takes 4 months and is still recruiting
does anyone Know what is taking so long to do clinical trials and distribution of the gloves to the public?
it seems for early stage PD?
The shik gentleman in Peter Tass videos looked like in advance stage, right? So. Hopefully it helps advance stage PD too?
yes we do hope it helps advanced stage so I wish that those beyond level 1 could be in the trial
I think it says for early PD?
It does sound like the planned clinical trial will be admitting people with early PD since it says Hoehn and Yahr stage 1
"The modified Hoehn and Yahr scale is as follows : Stage 0: No signs of disease. Stage 1.0: Symptoms are very mild; unilateral involvement only. Stage 1.5: Unilateral and axial involvement. Stage 2: Bilateral involvement without impairment of balance"
Hi all, The OHSU trial is proceeding very slowly. My husband began the OHSU Synergic trial in early July of this year. He was patient 15/30. And because 2 people had already dropped out (for unspecified reasons), he was actually the 13th patient. Unfortunately, the gloves design did not properly fit his hand in that the fingertips were too bulky causing the fingers to be held very widely causing tendonitis after 4 hours of use each day. His hands became discolored and swollen. Sadly he had to drop out of the trial after only 10 days on the advice of a physician who is a family friend and ER doc. The trial people had never seen this "side effect" before. Any glove we purchase in the future will have to allow his fingers to maintain a more natural position that doesn't strain the ligaments or tendons. 4 hours/day is a lot of time wearing these. We felt certain he started with the "sham" protocol based on hearing what the actual gloves pattern sounded like on videos. Consequently I (a 71 year old woman with no experience in this type of thing) decided to make him the homemade gloves (archery glove design) you can find instructions for on YouTube. I built them in about a week of diligent effort. He is now giving those a go for about 2-3 hours/day. It's still early times but we are seeing some hopeful signs of improvement. And his hands are recovered!
You rock! Will look for the YouTube videos.
Do you have a link?
I watched this one first which gave me enough confidence to build them. But you have to watch about four of these videos listed on this site to get the full concept and info. youtu.be/fWtaWdVaFi4?si=I6-...
Thank you! (I though you had your own videos) I'll check those out. I'm close but needed a better finger tip design to make them easy to put on.
I can confirm that 4 hours a day is a long time and the gloves are bulky and restrictive
I spoke to Dr. Tass a couple of weeks ago and he expects to start the trials in September 2024
Hi Anwar how are you? Are you using the gloves?
Hi, how are you? Are you using the gloves?
I have long held the view that "less was more" in vCR and that lower amplitude produced better results. Moreover, I "tune" my gloves using the 4 volume controls, so that I can just detect the vibrations
I was researching an answer to a question in a private message about customisation of vCR therapy and came upon this article I hadn't read previously,
ncbi.nlm.nih.gov/pmc/articl...
the proposal is to use "VTDT" to calibrate intensity. 2 comments were of particular interest
1) sensitivity is lower in PWP than healthy controls (so PWP need vCR louder)
2) sensitivity is (partially) restored in PWP taking ldopa
This suggests my regular personal recalibration of therapy (just detect vibrations) may not be such a daft idea
This is a quote from the article
"We hypothesize that due to vCR treatment, unwanted synaptic connectivity and, hence, abnormally strong interactions between index and middle finger decrease so that sensory input from index and middle finger can be processed in a separated and, thus, more efficient manner.
Effective CR stimulation requires that the overlap of stimulated neuronal sub-populations should not attain higher levels (17, 23, 53). Hence, there might be an intricate relationship between the vibration amplitude used for vCR and treatment outcome.
For instance, the stronger the abnormal synaptic connectivity between neighboring fingers, the smaller the vibration amplitude should be. However, particularly weak vCR may be less effective since the desired vibration phase-locked neuronal activity may occur in only smaller portions of the sensory thalamus and the sensorimotor cortex [see (16, 17)]. Hence, vCR stimulation might be more favorable if delivered at vibration amplitudes adapted to the VTDT results. Accordingly, during the course of vCR treatment the optimal vibration amplitude might need to adapt using VTDT results. However, this remains to be shown, e.g., in a first step by correlating VTDT and therapeutic outcome."
Hi Winnie,
Very good points. The question of finding the right stimulation intensity/ amplitude keeps coming back here (and perhaps needs a separate thread).
I have not yet used proper threshold testing such as by VTDT, but, very subjectively, I do think that the effectiveness of the vCR is substantially affected by the intensity setting:
(1) I think that there is a sweetspot of the intensity where the intensity is generally low, but high enough so that I can distinctly identify which finger was just stimulated. If the intensity is too low, I still have a sense that ‘my fingers got stimulated’, but could not clearly say in what order.
(2) If I do the vCR session at the sweetspot intensity, I feel much better afterwards/ the next day than when the intensity was too low. This observation might align with the hypothesis you quoted from the paper by Pfeifer et al.
(3) The sweetspot is not a precise single value, but lies in a certain range, which I use as upper and lower bounds for the random intensity setting I am using (specifically, I am currently using an intensity range of 5-9, out of a maximum range of up to 255).
(4) The optimal intensity range is not immutable, but depends on the temperature of the fingertips, general state of attention, tiredness, etc. I also find that sensitivity to the stimulation generally becomes larger during the vCR session, so that I sometimes do the second of my 2 x 2hrs sessions at a slightly lower intensity. (Sensitivity also continually increased over the last months.)
yes I am, hopefully will get the next generation of the glove sometime in September according to Dr Tass
Did you get them?
Aspen Neuroscience Trial - Autologous Neuronal Cell Replacement 
Phase 3, the Lighthouse study, Biogen and Denali, LRRK2 inhibitor BIIB122; New clinical trial registeredStem Cells TrialsVibrating Gloves for Parkinson's Disease
ANYONE IN THIS TRIAL: Prothena PASADENA Phase 2 trial? Love to hear what you think - some say most promising PD trial.
