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
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'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.
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?
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.
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
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!
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-...
Content on HealthUnlocked does not replace the relationship between you and doctors or other healthcare professionals nor the advice you receive from them.
Never delay seeking advice or dialling emergency services because of something that you have read on HealthUnlocked.