Vibrating Gloves for Parkinson's Disease

[Canddy]

For those of you interested in the FDA approval timeline for the vibrating gloves that pop up in various posts on this forum, I emailed Synergic Medical Technologies (they worked with Dr. Peter Tass at UCSF) regarding FDA approval of this medical device.

Here is the response:

The gloves are not yet cleared by FDA. We are running a pivotal trial at OHSU in the Portland, Oregon area and hope to use data from that for our submission to FDA late next year. I think it is likely to be 2025 before we have clearance to market the devices.

I will add your name and email to our distribution list for additional information as it becomes available.

Barbara Gaston, PhD

General Manager, Synergic Vibrotactile Division

Synergic Medical Technologies

Fingers crossed that the gloves actually become available to patients in late 2025/2026!

There are two studies on clinicaltrials.gov listed for Synergic Medical Technologies and both are recruiting:

clinicaltrials.gov/study/NC...

clinicaltrials.gov/study/NC...

[Ed-shakes]

talking about that, I’ve heard Jimmy Choi on this podcast talking about how he got a significant 30 points improvement on his PD symptoms thanks to the gloves:

spotify.link/edXkq0JJEDb

[Usufruct in reply to Ed-shakes]

I was disapointed in that Podcast as he mentioned the gloves spurred him on to do another Ninja Warrior yet none of the moderators asked any questions on the gloves or his 30 percent improvement on the movement tests.

[Gymsack]

I meet all the criteria except one.

to participate you must be close to the location where the company is so that you can go there regularly for evaluation.

test one is in Eugen , Oregon , USA

the other is in Portland Oregon

They are starting the recruitings stage, I expect that you might see some results late 2024 and some gloves on your hands , maybe in 2026.

[Dneezb in reply to Gymsack]

hi,I suppose Tennessee is too far for the trials! However I am interested in these gloves as they look most promising for freezing which i am doing constantly. Any update of when these will be available for the public? I presume you have to purchase them after they get FDA approval?

Any idea how I can get in touch with them? I have emailed several times but not heard anything back from them.

[MBAnderson]

Thanks.

Rats. Only in Eugene and Portland, OR

[Boscoejean in reply to MBAnderson]

I have been communicating with Synergic for months in hopes that my husband could be in this trial when it finally happens and I have received some emails from Synergic but none indicating that they will be inviting him to participate. According to their emails we on their list. We live close to Portland, Oregon so we meet the criteria. It would not be a major deal for us to go to Eugene either (2 hours away)This makes me wonder if this research is ever actually going to happen. We could have signed up to be in the trial at Stanford but the idea of the travel involved in that is more than we feel up to at this time.

[Canddy in reply to Boscoejean]

did you try to contact Oregon Health and Science directly?

Dr. Jeff Kraakevik: Phone [phone]; email: [e-mail]

or

Jaquie Ellison: Phone [phone]; email: [e-mail]

[Boscoejean in reply to Canddy]

Thank you. I will do that.

[Boscoejean in reply to Boscoejean]

it looks like one of the clinical trials ends December of this year which makes me think that this is the information for the people who have or are already getting the gloves in Eugene, Oregon and it seems very likely that this study has been filled even though it says recruiting in the listing. I really dislike the way they changed the clinical trials web site just because the old format was easier to read and understand

[Canddy in reply to Boscoejean]

I agree with you - I too dislike the changes they made to clinicaltrials.gov

[eschneid]

Thanks Candy,

I got the same info yesterday, same woman. as well. Too far for me and do not feel like spending the winter in Oregon this year.....bummer

[Canddy in reply to eschneid]

Oregon is too far for me as well - hopefully they will be fast at recruiting patients...

[Boscoejean]

If any of you are contacted by them I would like to hear about it

[WinnieThePoo]

I know both trials show their status as "recruiting" but I am pretty sure they are full (based on posts a couple of months back by others.

[Taranto98]

Would it be possible to get added to the mailing list as well?

[Canddy in reply to Taranto98]

Taranto98 - here is the website for the company I contacted:

synergicmed.com/

They have a place where you can sign up for the newsletter and also an option to contact them directly.

[Taranto98]

I forgot to thank you. So here is a belated thank you.