Nidra TOMAC update

[707twitcher]

I have been using the Nidra TOMAC bands for 5 weeks now. So far, I am pretty disappointed. There is some hope that more improvement will occur with continued use, but I'm not holding my breath.

I would describe my underlying RLS symptoms as fairly severe since augmentation kicked in last year. I still get twitchy legs, but I frequently have it in my arms and upper torso - and that just seems so much worse. It's a feeling that makes me want to jump out of my skin (or off a tall building...). Buprenorphine has been completely controlling my RLS symptoms for almost a year, but I keep seeking alternatives or ways to reduce dose in the hopes of reducing side effects (constipation, fatigue and insomnia for me). Because the bands are only meant to be used when you are having symptoms (they actually frequently trigger RLS if you use them when you don't have symptoms), I have reduced my buprenorphne dose - first to .2mg, then to .33mg, from my prior .4mg. I have used the bands when having symptoms at various times - midnight, 5am & naptime are frequent times for me. Roughly half the time, using the bands did bring complete relief for at least several hours. But the relief was enough to see me completely through the night (or nap) only about 25% of the time. The rest of the time I either got up earlier than I would have preferred or I got up and took more buprenorphine.

I also cannot say that my minor reduction in buprenorphine dose means reduced side effects. Probably somewhat, but not dramatically.

I have undoubtedly lost an average of at least one hour's sleep per night while trying the bands out. I'm not sure how much longer I will continue. For now, I'm thinking that I will ultimately revert to my normal buprenorphone dose and keep the bands around for the occasional break-through symptoms or afternoon naps. But I'll stick it out a while longer, hoping that continued usage improves results.

The fact that I have no out-of-pocket cost for the bands (Medicare and supplemental insurance) has made this experiment palatable. I would certainly be upset if I had to pay the $7,500 that they reportedly charge.

Stay tuned....

[Merny5]

Oh I’m so very sorry to read this! I have been eagerly waiting to hear your review. I had thought it might be beneficial since Dr. B said it was promising. I don’t think I’m going to purchase it now. Such a disappointment. Sorry

[707twitcher in reply to Merny5]

If your insurance will cover it, it might still be worth a try for you, especially if your RLS symptoms aren’t too severe. As you’ve probably gathered by now, we all react differently to meds, etc.

[Merny5 in reply to 707twitcher]

No, my insurance won’t pay for it. I filed an appeal with not luck

[ziggypiggy]

Thanks for the update. So when you had breakthrough upper body symptoms, did the bands ever help relieve them?

[707twitcher in reply to ziggypiggy]

Surprisingly the bands did help with arm and torso symptoms - sometimes. I think the more severe the symptoms, the less likely it is that the bands will relieve them.

[Joolsg]

Thanks for reporting back. That's really helpful.

[Spaceclaim]

Thanks for your review. Can you tell what is the difference to a TENS-device placing electrodes nearby the knees? I also don‘t understand why is it so pricey? I doubt it comes with some sensors just modulating electrical pulses going through the skin.

[707twitcher in reply to Spaceclaim]

I don’t know the difference with a TENS unit. I know the Nidra bands focus on the peroneal nerve. Do TENS units also do that?

They likely attempt to justify the price by focusing on the time they spend with each “patient “. They work with your doctor to get a prescription, work with your insurance to get coverage, spend time with you calibrating the bands to the appropriate level of signal, call weekly for a while to check status and answer questions, etc.

[Midnightsewist in reply to 707twitcher]

I am very interested in the Tomac bands but don't live in US so can not get them. I have been following the development and research which went in to them. Maybe that's reflected in the cost. I don't know but I think it was huge. Its definitely a lot of money to pay for a treatment unit and I think its life is around three years.

[Midnightsewist in reply to Midnightsewist]

Hi just to add that all the information on here and all of your experiences are a great help. Thanks for sharing. I have over the years tried various drugs, about 7 years ago was prescribed a few of those DAs. thank god I could not take them, they made me too sleepy and I could not drive. I need to drive as my husband doesn't due to various illnesses. I will read as much as I can about your experiences with medical treatment.

I have tried to get my GP to send me for iron infusion but to no avail. Maybe that is changing. I saw that research by Dr Earley in Johns Hopkins University on Restless legs and other doctors there, I tried to get my dr to read it. Not interested. They had information about the low iron in the brain which was the problem. It was 2017 and maybe 2018. My daughter told me at the time that it takes 8 years for the research to get to primary medical carers. Now I see Mayo clinic and others talking about it. So she was right.

How long will it take for me to get a tomac/nidra band. I have been emailing them for about two years and they say when it reaches EU or UK they will let me know. Seriously thinking of doing research on US to find a Dr or Consultant who would treat me and then a trip to US for an inperson consultation and hopefully a prescription. We have taken no holidays since Italy in 2019 so funds there for trip. I would have to work out how to get the replacement parts. Any info on this gratefully received.

[707twitcher in reply to Midnightsewist]

I would suggest contacting Noctrix to discuss your plans. They generally want you to have a doctor who will give you the Rx. In my case, my GP did. But there is no involvement on the doctor's part after filling out their paperwork for the Rx. So it's not a big commitment on the doctor's part. Perhaps they have worked with doctors who will do tele-health calls or who at least will see an out-of-state visitor and provide the Rx.

It seemed to take a month or two to complete the Rx process, but that included getting insurance approval. I gather you are willing to pay the $7500 since you will have no US insurance? Then another few weeks to line up delivery of the bands and a one hour calibration session. Noctrix contracts with other providers (in my case a sleep clinic located 2 hours away) to perform this calibration. So you may have to plan on two trips here - one to get the Rx and one to get the bands and have them calibrated.

There is an ongoing need to buy "disposables" - pads covering the electric contacts. I think that's $75 per month or so.

Here's the contact info I have:

Bonnie Chan

Patient Access Team

[e-mail]

Tel/Text. [phone]

Fax. [phone]

noctrixhealth.com

Or a general support email:

[e-mail]

Good luck! If you have been getting by with no meds, your RLS must not be too severe. In my experience, that is likely to make you a much better candidate for them than I am (severe symptoms if I don't use buprenorphine).

[707twitcher in reply to Midnightsewist]

I highly doubt that the cost to replace the bands eventually would be nearly as high. A good portion of the cost likely covers their upfront efforts to get participants insurance coverage, line up the Rx, schedule a calibration session when you pick the bands up, and frequent follow-up over the first couple months. None of that effort would be required to get replacements.

[Midnightsewist in reply to 707twitcher]

Thank you for all that. I will talk to them about doctors who might be helpful. Unfortunately my rl are very bad. I’ve tried several medications but after a few weeks the legs get worse. Then I stop taking them. I’m going to try the Gabapentin again. I sleep for an hour then stand or walk for hours. Listen to audible books wandering around. Eventually get back to bed for another hour. I. Take ordinary paracetamol and solpedine which is pc with some codeine. I am going crazy. During the day can fall asleep sitting at table etc. I need a solution. Going to check out your buprenorphine). thanks so much.

[teakabeagle in reply to Spaceclaim]

Apparently it is a novel waveform than TNS has. I didn’t notice much difference between it and using TNS in the same placement. Either way, the effects were not worth the price.

Price is related to the R&as, manufacturing, customer service etc. will probably decrease some in time.

[grandma_of_7]

Hi! I replied to your other post too.

I just had to quit buprenorphine (and before that methadone) due to opioid itch. I definitely know what you mean about those 3 side effects! For now my dr is increasing my gabapentin way too slightly in my opinion, I hope it goes okay, that's what he wants me to try, at least for 10 days. Then maybe Lyrica. I've been using kratom for a few days but I must have skin issues cuz it also caused itchiness. So I'm just going to quit using it.

Anyway, my dr just ordered the Nidra. I'm sure it'll take some time. So it sounds like, at the moment, you are not very satisfied with the darn Nidra. How maddening to have the bands stir up the RLS! I'm on medicare too.

I'm sad because for 3 years now I have almost never had to even think about my RLS thanks to opioids, but now it seems like I'll have to be quite aware of it, assessing what I do or don't need, keeping track, all that. It just seems so labor intensive and like I said I'm just not accustomed to even thinking about it. Bummer.

Thanks.

[707twitcher in reply to grandma_of_7]

Hopefully you have more success than me (so far). I think the fact that the bands trigger symptoms if you use them when you don’t have them may be just a function of their signal to the peroneal nerve being an on/off switch (my take on this- I haven’t seen Noctrix explain what happens). I used the bands several times when I had no symptoms because I was trying to use them daily in order to keep the adjustment process progressing. Continuing the 30 minute session, or starting a second one, did relieve the symptoms it kicked up.

[grandma_of_7 in reply to 707twitcher]

Thanks, and thanks for explaining a little more. Triggering symptoms would be such a pain! Glad that an extra 30 minute session cleared it up. Arghhh this is going to be such an adjustment! Thanks again

[lorri214 in reply to grandma_of_7]

I also have the bands. I have been using the bands for about 2 months. I find them very helpful. I don*Tt put the bands on until the rls starts. Once I put the bands on the rls goes away. Then If my rls comes on again I put the bands back on. I feel they definitely help. If you can get your insurance co. to pay it is worth a try. Good luck. Now I am trying to find a way to get off the methodone. Will discuss that with my doctor next week.

[707twitcher in reply to lorri214]

Since you are in a similar situation as me, can you share what you've been doing with your methadone dosing? Whatever dose you're using now is apparently low enough that you get symptoms occasionally. Have you reduced dose since you started using the Nidra bands? How often do you get symptoms and use the bands - every night? once a week?

My RLS is completely controlled with .4mg of buprenorphine. In order to trigger symptoms so I can use the bands, I have reduced dose to .33mg. At that dose, l get symptoms (usually within 30 minutes of going to sleep) maybe 2 or 3 times a week. Using the Nidra bands then does typically stop my RLS symptoms. But when I lower my dose further so that I can use the bands more regularly (they are supposed to improve performance the more you use them), then I run into problems. At .2mg of buprenorphine, the RLS winds up being too severe for the bands to help with it, or they only help for an hour or two. I'm at the 2 month mark for using Nidra. If I can't reduce my buprenorphine dose further, I won't be continuing with it I think. My opioid side effects don't seem any better at this slightly reduced dose, and using the .33 mg dose means I get woken up with symptoms a couple times a week. That wouldn't happen if I go back to .4mg.

[lorri214 in reply to 707twitcher]

I have been taking 12 mg methodone when using bands. I still get rls during night. When I get rls I turn on bands and rls goes away. The only problem with the bands is they work for 30 minutes then shortly lose their battery and I have to recharge in the middle of night. I usually get more than one rls during the night and I need the bands. So if I can walk around I can get the rls to subside. When the bands are recharged I put them back on when needed. I am supposed to take 15 mg methodone but I am trying to take as little as possible. The past couple of nights I took the 15 mg methodone. I did that last month also. But I keep trying to get off the methodone. I definitely think the bands help. The weirdest and greatest thing happened though. For the past three nights I have not had any rls symptoms. If I had any symptoms they were very slight and passed quickly. I have never went for 3 days without rls. Could the bands have done something even though I did not use them the past 3 nights??? Could it be because on two nights I took 15 mg methodone, but last night i only took 12 mg methodone and still no rls without using bands. All I can say is I will continue to use bands when my rls acts up. I have no idea why the rls stopped the past three days. I will see what happens tonite. I will try taking 10 mg methodone tonight. Fingers crossed.

[lorri214 in reply to lorri214]

Something just dawned on me. This past week I stopped taking omerprazole. I ran out of them. Maybe thats why I did not have rls symptoms??? I read omerprazole can make your rls worse. I am going to check this out. Tonight I will not take the omerprazole and tomorrow I will start again. I have been getting the heartburn symptoms so I need to take it. I will take the tums and see how that works.

[707twitcher in reply to lorri214]

Sue and others here say the only real heartburn medication that doesn’t worsen RLS is Gaviscon Advance. Chewable tablets. I’ve also found that taking a Pepcid in the morning helps without triggering RLS.

[lorri214 in reply to 707twitcher]

Today is the fourth day without the omerprazole and no rls. That is so strange. When I looked up omerprazole it said it can cause rls to be worse. Why didn't any of my drs. know that. I have been taking omerprazole for years. I always had rls. Now I stop taking it and the rls gets better. The drs. should know this and I should not have to be suffering. I plan to tell my dr. about this situation.

[SueJohnson in reply to grandma_of_7]

I may have told you this before but in case I didn't. Increase your gabapentin by 100 mg every couple of days until you find the dose that works for you.

Take it 1 to 2 hours before bedtime as the peak plasma level is 2 hours. If you need more than 600 mg take the extra 4 hours before bedtime as it is not as well absorbed above 600 mg. If you need more than 1200 mg, take the extra 6 hours before bedtime. (You don't need to split the doses with pregabalin (lyrica) if you switch )

According to the Mayo Clinic Updated Algorithm on RLS: "Most RLS patients require 1200 to 1800 mg of gabapentin (200 to 300 mg pregabalin)."

If you take magnesium even in a multivitamin, don't take it within 3 hours of taking gabapentin (it is OK with pregabalin) as it will interfere with the absorption of gabapentin and don't take calcium nor calcium-rich foods within 2 hours for the same reason

If you switch to pregabalin divide the gabapentin dose by 6 to get the equivalent dose.

[Swillet50]

Well I'm in the process of fettingcone in June. Sadctovhearcyoyr experience. I started taking 1 drop methlene blue with 1 tsp dmso at bed and no rls. Fingers crossed!!!