"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.
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grassgree
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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!
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.
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!
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.
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."
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.
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....
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.
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