To my email addressed to Peter Tass Lab of Stanford, Jessica Yankulova Kalinova, his collaborator, replies like this: "thank you for your email, unfortunately, the gloves will not be on the market at least until we get FDA approval which could take a couple of years".
Vibrotactile gloves.: To my email addressed... - Cure Parkinson's
Vibrotactile gloves.
It’s not a drug so why FDA approval? If it works they should just get on with it unless they’re using the time for further development purposes.
Medical device.
if it works I don’t think people would care if it has been classified as a medical device or not. If it is a “gadget” that would be fine by me. Perhaps you can charge more for a medical device?
We're talking about something that sends signals to the brain in order to treat PD. You can call it a tomato and its still going to be a medical device.It really isnt as simple as saying that it "works" or that it doesnt. What are the side effects and how likely are they to occur and in whom? What happens when someone without PD straps into it? Theres a billion other questions that need answering.
Actually what it does isn't so different from one of thesefruugo.fr/2pcs-electric-sho...
It's the intended use, eligibility for treatment paid by medical insurance, and the fact that stanford isn't a joke shop that create the need for fda approval. Stanford have a 2021 patent on the device (on the use of more than one electrical stimulation in a defined pattern therapeutically).
So whilst you could try to build a DIY version for own use, nobody else can sell a device commercially. If covid-19 doesn't interfere with the trials again it should "only" take a couple of years. It's much quicker than drugs.
Here is the complete equipment! Stanford also bought it here.
"Treatment of Neurological Diseases: Dr. Tass reports of use of vibrotactile stimulation to apply Coordinated Reset Stimulation (CRS), which has been shown to cause long-lasting reduction of pathological synchronization in parkinsonian monkeys. researchgate.net/publicatio...