New FDA approved therapy (fingers crossed!)

[JustVisiting23]

Dear fellow RLS sufferers:

My Kaiser doc informed me that there is a new device just coming to market for RLS. It has been approved by the FDA for mod-severe RLS, and is currently available in three states, CA being one. The machine is called the NXT 100 ToMAC, and it is somewhat similar to TENS. I don't know much more about this, but there was a brief mention in a news feed recently. I will be trying to get insurance to cover it, but I will likely be unsuccessful, and thus will have to spend $7,500.00 for the device. Because my RLS is severe and has ruined my life (via both the disease and the medication), I will have to find a way to pay for this. However, before I do, I am hoping that someone out there has some more information, or a more informed opinion, or perhaps has even used the device. Should you want to contact the company, their phone number is: [phone]. Sure would be amazing if this works.

[Madlegs1]

At that price, I can't see it being too popular?

Maybe Amazon will take it on?

[grassgree]

The device is still in clinical trials, but should be "available soon" in the US. You can read about it here; nidrarls.com/. Dr. Buchfuhrer directed the research and development. I don't know how long it will take to get insurance companies to help pay for it, but $7,500 is a bargain if it gives you your life back. There is a form to fill out on the website if you want more info--scroll down to the bottom. They might have a patient assistance program to help pay for it. Or they might tell you how you can get connected to a doctor to prescribe it.

[JustVisiting23 in reply to grassgree]

For those interested, it is currently available and patients are being fitted to be able to start treatment

[SueJohnson]

Do you know what the states are besides CA? Not surprising that is one of them since Dr. B is involved. I seriously doubt that any insurance would cover that high a price. And that is pretty expensive to try when it might not help. But if you are willing go for it and let us know your experience.

[Merny5]

Dr Buchfurer informed me that California is the only state that has the Nidra available while Massachusetts and Ohio are “almost there” He also indicated that any Dr. can write a script but the problem is that there needs to be a calibration center for the device. Where did you get that price tag! Yikes. I asked the company, Notrix Health if insurance would cover it and they told me that they are currently working with the insurance companies. I never did get a price.

[Elisse3]

Fingers crossed for you that your and others insurance will cover it. The relaxas pad fell by the way side because of the price of it and peoples insurance wouldn’t cover it

[RLSLearner]

Go Fund Me page?

[DCM556]

For that much, hopefully the company would include at least a 30 day money back guarantee on it working. That would suggest a good product and give you time to see if it works for you without losing that much if it doesn't work for you.

[JustVisiting23 in reply to DCM556]

I spoke with one of the scientists involved in developing the machine and he informed me it has a 45 day full refund policy

[DicCarlson]

So, this has been brought up before. Kinda fascinating - from their website: "Nidra gently stimulates a nerve on the side of each leg, which sends signals to the spinal cord. The spinal cord activates the muscles of the lower legs to mimic the sensation of movement. Muscle activation alleviates the discomfort caused by RLS, reducing symptoms and improving sleep."

It appears that the device mimics the patient getting up and walking around, yet staying in bed. I'm reminded of an RLS sufferer who got relief by pressing his feet on a footboard of a bed - similar strategy.

nidrarls.com/

[JustVisiting23 in reply to DicCarlson]

Yes, that is the mechanism of action as I understand it. The device won’t address the cause of RLS, but is designed for symptom relief. I think I’m going to give it a try.

[Eryl]

No device can undo the metabolic damage that gives rise to RLS. Any device is just a masking tool for the symptoms. Don't waste your money.

[grassgree in reply to Eryl]

Well, maybe it is just so much smoke, but researchers reported that all participants were better off two years after discontinuing the device. Symptoms got worse when they stopped, but so far, all participants were in a better place than where they started. There is not enough data to be sure yet, but sounds like there is reason for cautious optimism.

[Eryl in reply to grassgree]

The participants probably noticed the sumptoms more without the device but that does not mean that the symptoms increased when they stopped using the device

[grassgree in reply to Eryl]

If I understood the report, none of the participants suffered withdrawal such as what happens after using DAs. Symptoms reverted, but not all the way back to where they were when they started the trial.

[teakabeagle]

I participated in the clinical trial. Overall , it was helpful in only certain circumstances for me. If I did a session before bed,before symptoms started I could go 2-3 hour longer before it started. Once the RLS started, I did not get any relief from it. Once I got up and walked around to calm it down and did a session, I could get another 1-2 hours before it started up again. Normally , it would start up within minutes of lying down. I found that worthwhile, but

I found the battery life too short to be useful. You could get two, sessions a night. Because I have symptoms all night, wasn’t enough. I was told they didn’t want more than two sessions . I didn’t find the stimulation was consistent, but that probably has more to do with external factors like skin impedance.

I don’t know that I’d pay 7500 for it unless it had longer battery life

[grassgree in reply to teakabeagle]

Thanks for posting. I read that trial participants had refractory RLS, i.e. drugs had failed them. Was that true for you? Did you discontinue the trial or complete it?