New device: NXT 100 ToMAC

[IzzyKoshi]

Dear Friends:
My dr. informed me that the FDA has just approved a TENS-like device (it is NOT a TENS unit) for mod-severe RLS. It is currently available in three states, CA being one. I am hopeful someone is a new user, or knows a bit more about the device and supporting research. The company's phone number is: (415) 680-8984. I, like many of you, am suspicious as to new RLS treatments, considering how treatment-resistant this condition is. However, my doc, who is a movement specialist, did recommend that I try this device, and she will write a prescription. We'll see!

[Rustsmith]

I am not a user, but have seen the information from their clinical trials and have spoken with one of their representatives. It appears to be very useful for the treatment of moderate level RLS that is confined to the legs.

If you are interested, Dr Buchfuhrer (Los Angeles area) is running a clinical trial on the post-marketing, long term effeciveness of the device. You can find out more at: https://classic.clinicaltrials.gov/ct2/ ... w=2&rank=3

I tried to sign up for the clinical trial, but was turned down because my RLS is too severe. That is a common situation with clinical trials. Most do not want patients with severe RLS because they want to be able to demonstrate significant improvement using the IRLSSG rating scale and even if their product works for severe RLS, the numerical improvement would probably not be as significant as it is for those with mild to moderate RLS.

[gsurpur]

Hi, My sleep specialist prescribed me this device as I live in California, unfortunately my insurance denied it.
To buy on our own, its $6000.00 including the accessories. I do not know why my request was denied!

[ViewsAskew]

Hi, My sleep specialist prescribed me this device as I live in California, unfortunately my insurance denied it.
To buy on our own, its $6000.00 including the accessories. I do not know why my request was denied!

OUCH! That is a lot of money. How frustrating that they denied it.

[Lissa496]

Hi all,
Do you know if your insurance pays for this device, will they cut your medication back? Will they continue to pay for both? I would love to try and put in for this with my doctor but if it doesn't work would hate to lose my medications!

Also, has anyone tried the TheraPulse that is similar to this one out of England? It doesn't cost as much but seems to be similar. Here is the link https://therapulse.co.uk/?gad_source=1& ... fvEALw_wcB

Thanks all,
Lissa

[ViewsAskew]

Hi all,
Do you know if your insurance pays for this device, will they cut your medication back? Will they continue to pay for both? I would love to try and put in for this with my doctor but if it doesn't work would hate to lose my medications!

Also, has anyone tried the TheraPulse that is similar to this one out of England? It doesn't cost as much but seems to be similar. Here is the link https://therapulse.co.uk/?gad_source=1& ... fvEALw_wcB

Thanks all,
Lissa

No idea, Lissa. Wish I did. I haven't looked at the TheraPulse - I'll try to later this week.

[badnights]

What it seems to me is this:
Therapulse uses vibration.
TOMAC uses electrical stimulation.

The Therapulse reminds me of a Russian device called the Vitafon that uses sound waves to generate vibration. The vibration of the Therapulse supposedly activates muscles.

The TOMAC is more like a TENS in that it uses electrical stimulation. That stimulation is supposed to activate a particular nerve (the peroneal), which will activate a muscle. I can't tell if those leg cuffs are like electrodes, does anyone know?

[Lissa496]

Thanks for looking into this for us! As a tens machine works for me, it just doesn't stay on long enough and I get tangled in it. It would be nice to have a device that doesn't have all the wires.

Does anyone know if it helps the thigh and the calves at the same time? I usually put one lead on my thigh and the other on my calve.

Thanks ~ Lissa

[badnights]

I don't know, but I am always leery when I see devices that target the feet or lower legs and profess to interrupt sensory signals travelling to the brain. What about sensory signals arising from the upper legs, the arms? It's possible these devices work but the manufacturers don't understand how they work, and perhaps they work in some other way that can affect sensations in the upper legs. I don't know. If only they were cheap enough to try.

[frickets]

Noctrix Nidra Device (TOMAC) – the real deal or snake oil? I’ve been following and posting conversations regarding dopamine agonists (DAs), augmentation, opioids and such for years. I’m currently recovering from a horrible years-long DA augmentation and pramipexole detox. I’m hopeful for a nonpharmacological solution, but very pessimistic. My RLS has been so bad, and detox left me with my own form of PTSD, that it’s hard for me to imagine such a magical device could work.

The worst of my RLS symptoms came near the end of detox, ran through my legs and arms 24 hours a day, and only allowed an hour or two of broken sleep a day – sometimes NONE. I built up methadone and later switched to buprenorphine, while reducing pramipexole from 2MG+ daily to 0.25MG.

Post detox efforts my current condition is pretty good (best in a few years), but I am still struggling to zero out pramipexole. I’m getting 8 hours of good sleep, and my symptoms are very light to non-existent - limited to my legs and evenings only. Getting off the last small dose of pramipexole has been very difficult, but I’m committed to doing it as I fear it will eventually fail me again.

My fairly new-to-me neurologist, who specializes in movement disorders, is recommending that I consider the Nidra device. I’ve been reading about the various trials/studies that suggest it’s possible – presumably ethical sources such as the NIH. The availability of this device is very limited, and only recently became available in my state. I haven’t seen a lot of experiences shared within this community yet. I’m considering looking into its affordability and effectiveness. Any new updates in this space? As always, much appreciated. Thanks

[Rustsmith]

It is still new enough that there haven't been many here that have actually have the device except for a few that were involved in the clinical trials.

First, it isn't cheap, which is to be expected for a device that had to go through both development and extensive clinical trials in order to receive FDA approval for treating RLS.

Second, I had a chance to speak with one of their reps the sleep medicine conference where it was introduced (I also go to read their research posters that were results and not sales pitch). The rep that I spoke with said that it is probably a device that is best suited for those with mild to moderate and maybe low severe levels of RLS but that it would likely not be as effective for those with severe to very severe RLS. Further, because it is worn just below the knee, it would not be as effective for those whose RLS is in their hands, arms or torso. But he said that it had helped reduce some of those symptoms in a few in the trials.

It wasn't something that sounded worthwhile for me personally since my RLS is currently well controlled by meds, but it would be something that I might consider trying if I lose control, especially if I could get a device to try and return if it didn't work.

[badnights]

I agree with Steve that it's not likely to resolve your symptoms completely, especially since at this point you're not even over the pramipexole experience yet (brace for more bad symptoms during the final withdrawal, but remember, you can do it, because you've already done similar).

Even so, I think it would be a good thing to try. It should - in theory - reduce symptoms, even if it doesn't eliminate them. Anything that reduces symptoms, and especially, reduces them non-pharmacologically, is good. The less symptoms, the less meds we need.

I would try it in a heartbeat but that $7000 price tag is a bit of a show-stopper at this point.... maybe not if other people are able to try and post positive results, then at least I would be more sure that I would not be throwing the money into the wind. I'm watching this with you, @frickets

[ViewsAskew]

I wonder if Medicare will cover the cost for those of us in the US over 65?

[ViewsAskew]

Ah - I did a search and found the answer myself:

https://www.prnewswire.com/news-release ... 24898.html

Yes, Medicare in the US will pay for this given certain codes are used.

[frickets]

Following up on my (frickets) post above - "Noctrix Nidra Device (TOMAC) – the real deal or snake oil?"

After considerable thought, I contacted my neurologist and declined to pursue Nidra at this time. Apprehension over its effectiveness with extreme cases, the short money-back trial period, memories of the horrible detox I went through a few months ago, the fact that I’m currently doing well with medications, the inevitable battle with insurance and the large expense of my co-insurance responsibilities – all weighed on my decision. My doctor replied with understanding and offered a few points for future consideration:

- “The major studies included patients with at least moderate RLS (IRLS score >15). Also, two of the main trials ran for 4 weeks and 8 weeks, respectively. “
- “Since this just launched in [our state], I have not yet received any insurance decisions and thus cannot comment on how difficult it will be to get.”
- “Insights from some of my colleagues in CA suggest that Nidra can be a powerful adjunct to oral medications, including in cases of severe RLS managed with opioids.”

Still, I am going to pass on this option until my condition worsens or more supporting real-world evidence becomes available.

Forward we stumble! Thanks all.