Newly approved treatment for RLS

[grassgree]

A physician in the family sent me this link for a device that has just been approved by the FDA;

Prescription Device Cleared for Patients With Drug-Resistant Restless Legs Syndrome

empr.com/home/news/medical-...

"The device suppresses RLS symptoms by activating the peroneal nerves bilaterally using high-frequency, low-level electrical stimulation to produce tonic, sustained muscle activation. Using the Clinician App, a prescriber can calibrate therapy output specific to the patient. The user-interface on the device allows patients to start or stop stimulation, adjust intensity, and read battery status."

You can read more about it at the link above. I don't know whether to be hopeful or skeptical, but thought you'd like to know. Please post a message if you've asked your doctor about it.

[Madlegs1]

Looks similar to the Therapulse device.

Main problem with that seems to be weakness of the velcro straps.

This looks a bit more robust.

[ChrisColumbus]

This got some interest on here nearly 3 years ago when it got FDA Breakthrough Device designation. If there's been any more recent mention here I've missed it. Prescription only in the US, and I can't see anything about it here in the UK: Noctrix Health's website is singularly uninformative!

[grassgree in reply to ChrisColumbus]

Wow, three years ago? I wonder what's been going on in the interim. Maybe it's cost prohibitive and the insurance companies won't pick it up? Maybe it's not working as well as hoped.

[ChrisColumbus in reply to grassgree]

FDA approval came after a clinical trial carried out on 133 participants in 7 US states: it ran from May 2021 to March 2022, and was marked completed the following month. I don't know whether it's abnormal for FDA approval to take a year from completion of trials - but I suspect it's routine!

[grassgree in reply to ChrisColumbus]

I don't think a year is abnormal. The FDA takes its time, then they might ask for clarification or more information, and that might require the developer to run more tests. I found a bit more information, including this quote from Dr. B;

"As someone that has treated thousands of RLS patients, authored many of the clinical guidelines and multiple books and articles on managing RLS, I see tremendous potential in having this new therapy in our clinical arsenal. Use of this device could prevent the need for up-titration of dopaminergic agonists in patients with worsening symptoms caused by dopamine drug induced augmentation," said Mark Buchfuhrer, MD, Clinical Associate Professor at Stanford University School of Medicine.

You can read more here;

kron4.com/business/press-re...

Apparently the principal investor is also the Medical Director of the Ohio Sleep Medicine Institute; Asim Roy, MD. That seems positive.

Now to see if the insurance companies will go for it. I guess that's why it's designated only for refractory RLS. Pills are so much cheaper!

[rls-ottawa in reply to ChrisColumbus]

The FDA has cleared the NTX100 Tonic Motor Activation System for the treatment of medication-refractory moderate to severe RLS

[ChrisColumbus in reply to rls-ottawa]

Yes, that's the blurb in the MPR piece.

The FDA stated they "granted marketing authorization.....to reduce the symptoms of primary moderate-severe Restless Legs Syndrome (RLS) and improve sleep quality among drug-resistant RLS patients."

[SueJohnson]

I'd be interested in what it costs without insurance. Please let us know. Also if you get it let us know how well it works.

[grassgree in reply to SueJohnson]

Yep. If the developer announces a program to get it directly from the company, I’ll post the info. A prescription would be needed, and I’m just guessing that the physician would want training and familiarity with the device before he or she prescribes. So it will be a while. But it’s good to have hope.

[FLfish in reply to grassgree]

interested and following 😃

[RCHD]

does it work?

[ChrisColumbus in reply to RCHD]

That was the point of the clinical trial that led to the marketing approval: it reportedly found 'statistically significant improvement in RLS symptoms' and 'improvements in sleep quality' with 'No significant adverse events'.Of course, whether these 'improvements' are worth whatever it will cost, whether that cost will be covered by medical insurance, whether/when it will see the light of day outside the US....

[ChrisColumbus in reply to RCHD]

And as quoted above, DrB feels it has "tremendous potential"

[LanaCSR]

I am definitely interested in following this...😊

[WideBody]

Yes, absolutely please keep us updated. I am very interested. Thanks for posting.

[Tanker1]

I wonder if it works for periodic limb movement disorder? And could one sleep with it on?

[coldfeet7 in reply to Tanker1]

That was my thought! My PLMS is a much bigger issue than the RLS which is mild during the evening, especially if I steer clear of sweets.

[RLSgirl]

I'd be interested in trying this. I can't find any info on the cost.

Since it's prescription only i guess I'll reach out to my Doctor and ask him about it.

[Merny5]

I’m definitely interested. I am going to speak to my neurologist about it when I see her in June. The fact that Dr. B indicates it is promising, gives me some hope. I think all of us have spent way too much money on products that don’t help.Thank you so much for sharing this with us.

[Inallfairness]

Me too,Very interested in this,please keep us all posted ..👍🙂

[grassgree in reply to Inallfairness]

Definitely.

[Opie__]

Following

[Tailwind53]

Following here too.

[glosrunner]

Hallo Grassgree. Interesting Post. I would be interested in this if it becomes available, too.