This only includes a summary and I don't have time to see if a full text is available anywhere free.
The report is dated 7Sep23 so its the latest news around. If I study "tomacs" for the next 10 years I might even be able to understand it.
Sounds like good news but it might be very ambitious. It will certainly be a fair time until it hits the pharmacy shelves.
I don’t have access to the article either. It looks like an editorial. Discussing the sorry state of affairs in the RLS world.
This was discussed on the form awhile back but I can't find it. These are my notes on it:NTX100 tomac system is prescription and similar to therapulse - Tonic Motor Activation - FDA approved coming out this fall 2023 The prescription therapy includes a pair of devices worn on the lower legs that electrically activate the peroneal nerves bilaterally to produce tonic, sustained muscle activation to suppress symptoms of RLS- It looks very promising but no cost was listed.
It won't allow patient access sadly.Off to look up TOMACS.
academic.oup.com/sleep/adva...
This link seems to work and shows the full article. It is a device, as SueJohnson advises, delivering pulses to the lower legs.
I'll see if I can find cost. Maybe the manufacturers will let several members of this forum trial it.
empr.com/home/news/medical-...
FDA has approved the device in the USA, so presumably, people will be able to buy it with a prescription from their doctor. I remember restifixx foot pads could only be purchased with a prescription.
Enquiries to this company will presumably reveal the price.
The device got FDA approval in the spring but I don't think it's available to the general public yet. The company (Notrix Health) is still doing a limited rollout. You can write them at info@noctrixhealth.com and get on their list.
The longer article indicates that study participants not only found their condition improved, but the longer they used the device the more improvement they got. So far, the study only tracks 2 years of use, but during that time, most participants' sleep continued to improve. If they quit the device, their RLS got worse, but did not go back to their previous baseline. That is, there were no withdrawal symptoms and there seemed to sustained improvement. I will paraphrase badly, but they seemed to theorize that poor sleep sets a vicious cycle in motion, and that "neural plasticity" over time might confer a permanent benefit. They aren't sure. But so far the device is helping. Dr. B at Stanford is part of this company.
Also, you can write TOMAC in the search bar to find the original discussions. Thanks, Graham, for posting this article. I don't know how long it will be before the device will be available for everyone, and they haven't set a price. But hey, long term studies are important, right? The decision to go forward shouldn't be too fast.
Hi Graham, I have just made a separate post on a TOMAC device as i thought it might get lost if i post it here in reply.
From memory i believe you're also in Australia, so some of the information might be of particular interest to you.
This sounds amazing and the participation of Dr Buchfuhrer (if that is correct) gives it real credibility. Perhaps EARLS could organise a bulk order at a special price. I havent even heard what the price and availability is yet so its a bit pie in the sky.
If someone ordered a number of units it might speed up setting up mass manufacture so it will be affordable to all for less than the annual cost of medication - perhaps. Great risks but the reward is worth dreaming about.
BBGGG wrote to Notrix Health and got an answer from the Clinical Research Coordinator, Lisa Armstrong, (lisa@noctrixhealth.com). She said that if you let them know where you live in the US, she would provide a name of the closest provider.
Yes--it's Dr. Buchfuhrer who is involved with the company. Thanks for spelling it.
I was told it is rolling out in only a few states at the moment and that I would be notified when it was becoming available near me via email
Hi Graham,
I have been in contact with the company about availability here in Australia. They are really concentrating on the US market first then UK/Europe. I said i would be happy to help set up trials here in Australia if that is what they need for the TGA but as a medical device I dont think they should need it. I will keep in contact with them and see where I get. It will work for some people but not everyone.
there is always hope !
They will need a hefty price to cover all their investment into development so I will start saving now. I was trying to think of ways to spread the cost but if you need 4 hours per day its pretty difficult. You would have to be next door neighbors. Something like a public library that was open for 24 hours and you could read books while you cure.
I think I will just start saving !
There are possibilities like what if you spent 24 hours on the machine for one whole day per week? And the negative What if it only helps 20% of patients when its out of the trials and in the real world.
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