Tonic Motor Activation (TOMAC)

There have been a couple of posts on TOMAC devices recently.

I've just dug out an email I wrote in June this year to the company making one such device - Noctrix Health. Here's Noctrix Health's reply..

"The FDA has recently allowed us to start marketing and distributing our wearable medical device that is intended to reduce symptoms of primary moderate-severe Restless Legs Syndrome and to improve sleep quality in adults refractory to medications.

With the FDA granting us the ability to start distributing our product, we are currently building up our inventory to support demand and will provide updates on the availability of the product to patients and physicians.

We expect to start a limited launch of product release ONLY in certain U.S. geographies later this summer. We are not allowed to sell in countries other than the U.S. currently. We greatly appreciate your patience as we continue to work to make our technology available to those that need it most. We have added you to our list of patients to stay in contact with as new developments arise and as our Noctrix product becomes more available."

**Here are the specific questions i asked Noctrix Health:

1. Does the TOMAC System treat Periodic Limb Movement Disorder?

We have only studied our device in treating RLS

2. Are there any plans to have the TOMAC System approved by the Australian Therapeutic Goods Administration (equivalent to the US FDA)?

Currently we are concentrating in the US. This may change as we grow and scale.

3. Is it possible to purchase a device privately? I'm in Australia.

We are only allowed to sell in the US currently. Do you ever travel to the US?

4. Is it possible to receive a copy of the outcome of the trial which resulted in FDA approval of the TOMAC System?

Thank you for your inquiry regarding our clinical trial data. The results of our randomized controlled trial, which was the basis of our FDA De Novo grant, are currently under review for publication in a journal. When the results are publicly available, we will share a link to the paper on our website. Until that time, the publication of our pilot trial results, which was the basis of our FDA Breakthrough Designation Grant, can be found here. You can also learn more about the mechanisms of action that govern our device in the publication found here. Please do not hesitate to contact us if you have any further questions about the studies or our device.

[Joolsg]

Thanks Amrob. There is a similar device available here in the UK called therapulse.I think there are a few posts about it and some people say it helps.

healthunlocked.com/rlsuk/po...

I've read some reviews, and most say it helps. It's sad to read so many are taking dopamine agonists though.

uk.trustpilot.com/review/th...

[Hidden in reply to Joolsg]

Thanks for that information Jools. I've just had a look at the Therapulse device and i'm wondering what the actual difference is between that and the Noctrix (TOMAC) device for example. The former refers to vibration therapy whereas the latter refers to neurostimulation therapy, although the Therapulse couldalso be considered a neurostimulation device. The differences in terminology make it difficult to establish the difference, if any, between them.

[Hidden in reply to Joolsg]

Might have to consider trying this.

[BoldMove]

Please keep us updated. What I'd like to find is a pad I can lay out that emits a steady massage.

[Eryl]

Any device will only mask the sensations that give rise to RLS not alter the causes of the sensations which I believe is inflammation of the nerves in the legs which makes them hypersensitive.

[RLSLearner in reply to Eryl]

Most theories look more at transport of iron into the brain, maybe the spinal cord and then affecting various neurotransmitters such as Adenosine and Dopamine. Maybe if it is something in the spinal cord then stimulation to the nerve in the leg may cause a change back in the spinal cord. But I agree it is not likely to be a cure. But if medications are not agreeing or available to a person and they get a decent night sleep with this, then someone will kiss their feet.

[Eryl in reply to RLSLearner]

I have completely eliminated my RLS just by changing my diet to avoid inflammatory foods.

[RLSLearner in reply to Eryl]

I 100% agree that should be the basis (for all health issue, or just wellness) - but how many people really commit to that even with all they go through.

[Eryl in reply to RLSLearner]

To easy to buy another gadget or pop another pill.

[Baz33 in reply to Eryl]

You're lucky , this is not the case with me

[Eryl in reply to Baz33]

Have you really tried?

[RLSgirl]

I also saw this and am interested in trying it. but it seems to not be available yet. they also told me they would let me know when it is available for my doctor to prescribe.