Stanford Glove trial: I was sure someone... - Cure Parkinson's

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Stanford Glove trial

WinnieThePoo profile image
26 Replies

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

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WinnieThePoo profile image
WinnieThePoo
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26 Replies
Boscoejean profile image
Boscoejean

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

Fed1000 profile image
Fed1000

Hi, when I see you I can't help but, ask how you are and how your gloves are going? Happy mid-August.

WinnieThePoo profile image
WinnieThePoo in reply to Fed1000

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!

Fed1000 profile image
Fed1000 in reply to WinnieThePoo

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.

Parkie123 profile image
Parkie123

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?

WinnieThePoo profile image
WinnieThePoo in reply to Parkie123

No - they are open label

Shorebird profile image
Shorebird in reply to Parkie123

It looks like subjects act as their own controls - so they undergo actual treatment and “sham” treatment during the study.

WinnieThePoo profile image
WinnieThePoo in reply to Shorebird

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..."

Parkie123 profile image
Parkie123 in reply to WinnieThePoo

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.

Shorebird profile image
Shorebird in reply to WinnieThePoo

Sorry! My mistake! I love the story!

Neurosmith profile image
Neurosmith

The two Synergic trials are here:

clinicaltrials.gov/study/NC...

and here:

clinicaltrials.gov/study/NC...

WinnieThePoo profile image
WinnieThePoo in reply to Neurosmith

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

TL500 profile image
TL500

does anyone Know what is taking so long to do clinical trials and distribution of the gloves to the public?

TL500 profile image
TL500

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?

Boscoejean profile image
Boscoejean in reply to TL500

yes we do hope it helps advanced stage so I wish that those beyond level 1 could be in the trial

TL500 profile image
TL500 in reply to Boscoejean

I think it says for early PD?

Boscoejean profile image
Boscoejean in reply to TL500

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"

threezees profile image
threezees

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!

busters_dad profile image
busters_dad in reply to threezees

You rock! Will look for the YouTube videos.

busters_dad profile image
busters_dad in reply to threezees

Do you have a link?

threezees profile image
threezees in reply to busters_dad

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-...

busters_dad profile image
busters_dad in reply to threezees

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.

threezees profile image
threezees in reply to busters_dad

youtu.be/fWtaWdVaFi4?si=I6-...

WinnieThePoo profile image
WinnieThePoo in reply to threezees

I can confirm that 4 hours a day is a long time and the gloves are bulky and restrictive

Ksbhutani12 profile image
Ksbhutani12

I spoke to Dr. Tass a couple of weeks ago and he expects to start the trials in September 2024

Fed1000 profile image
Fed1000

Hi, how are you? Are you using the gloves?

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