Has anyone tried the Parasym transcutaneous vagal nerve stimulation device (tVNS)?
Info at Parasym.co
It’s still awaiting FDA approval here in the US, but is apparently cleared for use in England (where it was developed), as well as in Europe and other countries.
Dr. Hugh Calkins, my new EP at Johns Hopkins, heard about it at the big heart rhythm conference in May where they presented a paper on a trial done here at the University of Oklahoma so he was very open to the idea of me trying it, when I brought in this article that a friend sent me:
Parasym has no idea when they will get FDA approval, so I’ve been trying to figure out if there’s any way I can get relatives in Germany to help me get it (unfortunately, FDA rules prohibit bringing or mailing it into the country, even by an individual). I’m still working on it, and researching other, similar devices, but I’d really like to hear anyone’s experience who has tried this specific device that has had such amazing results in this trial.
Thanks, as always, for your insights!
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hartbeast
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We've certainly heard and talked about this tVNS device on the forum, but as far as we are aware it's still under trial here. Certainly no one so far has mentioned having access to it.
Thanks jeanjeannie - yes, my EP and I are certainly excited! In my case, I have no other health issues, other than the stroke I had which informed me I had Afib. And there seems to be a significant vagal connection to my episodes (gut, heart, brain, jaw - they all set each other off!) so I’m hopeful it could really be helpful for me. I couldn’t find anything about this device on the AF forum, only in tinnitus and fibromyalgia and a couple of other places on HealthUnlocked. So I am happy to hear it’s been under discussion. I can confirm that it is now available in England and Europe, at least according to the Parasym.co website. You lucky folks in England can even rent it for 40 pounds a month (3 month minimum rolling contract) so you can see if it does you any good before you sink the full 600 pounds into it. I’m envious when I read about some of you getting together for a cup of tea in a lovely English garden somewhere (or so my imagination has it) – now you could pass around the Parasym device and see if it helps!
That's a lovely image you have, but we usually get together in a nice hotel in the heart of a city.
If I thought for one minute that this device would restore my heart to normal sinus rhythm I'd buy it, but as I'm unsure - I wont! I hope someone here will and then feed back whether it works or not.
As you know we have recently talked about this. Has anybody been advised of it,'s availibility here by medical practitioners? Surely it wouldnt be on sale here if it weren't approved.
I talked to Parasym and they said it was approved in UK and EU. I’m not familiar with how your health system works, so I’m not sure if “approved” means available through the national health or just that you are free to spend the money and buy it yourself. I was still surprised when my EP at Johns Hopkins was excited for me to try it – although he wouldn’t go so far as to sign the FDA special permissions form that said he would oversee my treatment. But when I saw him, I thought I had figured out a workaround and he wanted to see me in eight weeks to find out if it did any good for me. Apparently a former student of his headed up the study at the University of Oklahoma, and there was quite a buzz about it at the big international heart rhythm conference in May. (And I like your handle, lion heart!)
Very useful information, thank you. I intend to rent one for a period. Do you know whether one uses it daily as a preventative or only when one has an attack?
In the study, participants used it for an hour a day for the entire length of the trial. My understanding is that the device tones the parasympathetic vagal system through this extended use, which makes it more able to respond. This limits the automatic fight or flight response of the sympathetic vagal system which can trigger an episode. But because relatively little is known about the vagal system, I’m guessing they don’t really know exactly why it works. But it’s fascinating to me that the subcutaneous vagal stimulation devices that have been used for a number of years have been so effective with epilepsy, tinnitus, fibromyalgia, etc. I couldn’t find information on subcutaneous devices used for afib, yet these trial results for the transcutaneous Parasym seem pretty astounding. I don’t know if all afib suffers have such strong vagal connections to their episodes, but I sure seem to! Looking forward to hearing about your experience - I would review the protocol used for the study (in the link) to consider the best way to use the device, especially since it sounds like they won’t specifically recommend it for a fib yet.
I became aware of possible Vagal connections when I suffered afib following swollen stomach after evening meal. The theory that it could of been vagus nerve problem has been around for some time perhaps triggered by lack of the right bacteria in the stomach. I also tale pro biotics and a magnesium supplement. I am always looking for answers as I don't like the idea of drugs and ablation for the rest of my life. So, I am hopeful.
I look forward to read your posts as you will be starting the "test" before me.
When you think about how wildly divergent any particular medication’s effectiveness is (just follow a conversation thread about any of the anti-arrhythmics on this forum - or even ablation) as it varies from person to person, the results they got in the Parasym trial are so much better than what passes for success in a prescription trial...
I've been reading about various ways to stimulate the vagus nerve, and the Parasym device sounds very promising. If it was available here (in Canada), I'd buy it.
I am seriously looking at purchasing this! They will not send to us or to Canada but we have friends in Mexico too, so that may be an option. This is something I am very willing to try.
WOW ! Ive been reading from your link and .... WOW. I would definitely sign up for that clinical trial.. Still reading and loving all of what Im reading. Thank you for this link.
I would too! I asked Parasym if there were any upcoming US trials and the said no, alas. But I plan to get in touch with the University of Oklahoma team and see what I can learn.
What would the difference be between the Parasym transcutaneous vagal nerve stimulation device, and a TENS unit (get the ear clips) which is sold everywhere?
My understanding is that the TENS device won’t do at all the same thing. There are specific wavelengths and other science-y things I haven’t researched but that I’ve been told would make a big difference.
Was tempted by the Parasym rental option, but wanted more evidence of benefits. So bought the earclips for my TENS unit 2 weeks ago. Missed using it a few days this week. Hasn't helped so far, but I am having my worst spell of flutter, about 135 bpm for 2 weeks. Had similar twice in July, that were converted with cardioversions. My EP says that there is no point in trying them anymore as I will always revert. So I am now on a list for an urgent pace and ablate.
So sorry to hear you’re having such a bad couple of weeks, vhnyc. As I said in my reply to Bambi65, I don’t think the tens unit is comparable. My first impulse was to life hack with the ear clip and tens unit, and I was told that wouldn’t do the trick. Wishing you all the best with your pace and ablate.
I transposed your handle and thought you were in NYC, vhync - But now I’m guessing you’re on the other side of the pond, since you have access to the rental option. I’m so curious to hear if it might help someone outside that study. The numbers looked so good…
So after reading your post and following the link, I've just ordered the Parasym device for rental. I have persistent AF and am waiting for a cardioversion but I also suffer from tinnitus and digestion issues so I figure if it helps any one of these things it's got to be worth a try. Will let you know how I get on!
I contacted them about using for svt/Afib and got the following response...
Thank you for reaching out and for your interest.
We have just completed a study which demonstrated the beneficial effects of the Parasym in patients with AF, however our device is not approved for sale for this use case yet and for cardiac conditions. If you would like to register for updates on this application, please complete this form. For your safety, we do recommend consulting your physician.
Hmm that's interesting. I had to fill in lots of information when ordering and cited AF but they still accepted my order. I did mention tinnitus as well though so maybe they accepted it on this basis. They may not be approved for this use but unless there's any risk, which there doesn't seem to be, I think I'm still prepared to give it a go. Seems to me that the worst case scenario is it does nothing and I've wasted £130....
That IS interesting. But I guess this is how these things work. However, just like medications, don’t physicians sometimes prescribe for “off label use“? And then, eventually, enough studies are done that they approve it for the additional off label use.
Did they say they wouldn’t rent it to you, or just that you had to get a doctor’s ok? Or that you have to claim to have tinnitus (or another approved condition) in order to get it?
No they didn’t say anymore than what’s in the email pasted. I’ve got my yearly cardiology appointment on 2nd September. I’ll ask him then what his thoughts are about me trying it out.
Looking forward to hearing any feedback with any that are trying it.
OMG.... I have been really investigating this study and a few others that talk about vagal nerve stimulation for Afib. There have been many ways to stimulate this almighty nerve. Here are a few that came up:
Massaging the throat, putting face into ice water, taking a very cold shower, being submerged into ice water, humming, deep slow breathing, Pulsed Electromagnetic Field (PEMF) therapy, gargling, tongue depressors stimulate the gag reflex (gag reflexes are like doing push-ups for the vagus nerve while gargling and singing loudly are like doing sprints.) Traditional acupuncture, and Chewing Gum. But my favorite of all was from a medical journal........
CAse RepoRT
Clinical Medicine Insights: Case Reports 2010:3 51
Instantly converting Atrial Fibrillation into sinus Rhythm by a Digital Rectal exam on a 29-year-Old Male
Cheng-Huai Ruan New York Hospital Medical Center of Queens/Weil Cornell Medical College Affiliated Hospital, Department of Internal Medicine, Flushing, NY, UsA. Corresponding author email: chr9062@nyp.org
Abstract: Vagal maneuvers cause increase in vagal tone, which has been shown to slow many types supraventricular tachycardia, such as atrial fibrillation (AF). However, the conversion of AF to sinus rhythm is usually not associated with vagal manuvers. Thus, AF is classically treated with medication and electrical cardioversion. Here, we present a 29-year-old male with no cardiovascular history and a low atherosclerotic risk profile who developed AF which converted into sinus rhythm immediately after a digital rectal exam. The patient remained asymptomatic after a 3-month follow-up. This implies that the digital rectal exam can be considered as an
additional attempt to convert AF to sinus rhythm in AF patients.
Keywords: atrial fibrillation, AF, sinus rhythm, vagal
Ok, I dont know about the rest of you but Im really thinking about getting the Parasym transcutaneous vagal nerve stimulation device (tVNS), more than ever!
We all have options. Thought everyone could use a good laugh today.
Yes, so many different ways to activate the parasympathetic vagal system, but I hadn’t heard that one yet! 😂
I also found a terrific book called accessing the healing of the vagus nerve, by Stanley Rosenberg, that gives several very simple exercises ( involving head and I movements, mostly) to activate the ventral vagal system (connected to Steven Porges’ work on the polyvagal theory of the vagus nerve).
My Parasym device arrived today but I've been at a wedding all day so no chance to use it! I'll start tomorrow. I think I'll definitely give it a go first before taking the digital rectal exam route lol
Yes, just try the one you got today. If it dosent work you will always have the rectal route available. Either way... Let us know. curious minds want to know.
How often are you in Afib, how long does it last, take medicine to control rate or frequency? Just wanted to know how your machine will be validated for your afib. Cant wait to hear how it goes.
Hi Bambi, I'm in permanent af, once it goes it goes and I have to get a cardioversion. I know as soon as it's gone out of sinus. My cardiologist wrote a letter which gives a brief history and recommends cardioversion, which I carry with me and present at a&e. Normally what happens is I take flecainide first and if (when) that doesn't work, I go to a&e and they generally just give me a cardioversion. Unfortunately for me this happened 23rd June, I was cardioverted and then it went again 3rd July. Obviously as it was too soon after the last one they wouldn't do it again, so I'm now in the ridiculously long waiting list for the arrhythmia clinic, I'm told it'll be October! I'm on bisoprolol 2.5mg, and I have hypertension as well. I might as well tell you I'm a 55 year old male (Dave!) living in the UK - East Midlands.
If I'm honest I really don't know what to expect from the Parasym device, I find it hard to believe it'll cardiovert me, but even if it goes some way to alleviating the symptoms e.g. reducing my heart rate or the shortness of breath then it's got to be worth it
what is a & e, ? Ive seen this many times and thinking it may be an emergency room at a hospital? So yall have to wait to get to see your doctor? Well I sure hope this machine will work for you. Please let me know what it does for you. Fingers crossed
Sorry yes, emergency dept. or accident and emergency as we call it. So I'm now in the waiting list for a cardioversion. Our NHS is a fantastic institution in many ways but it's over burdened and under funded. I'm hooked up as I type, the tingling is really unpleasant when it kicks in but ok when you dial it back down
i truly hope this works for you. If you like I can send you a rectal Thermometer as "back up" or maybe just go to you doc and have him check your prostate .. LOL
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