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Vagus Nerve Stimulation
I have watched it. I don't recommend it for several reasons.
The presenter is an OT who has had several short bouts of PVFS/ME lasting from a few months to a current bout of over a year severe, now mild and back at work. She has tried lots of different treatments, including nutrients, probiotics, meditation, therapy, etc. and a very expensive instrument that you clip on a specific part of the ear to stimulate the vagus nerve. She is enthusiastic about all the different treatments, claiming they all helped her.
She builds in lots of caveats that she is not a scientist and is not doing research, then proceeds to try to invent hypotheses based on a superficial view of Naviaux cell danger response hypothesis and ANS overstimulation, and talks about the role of the vagus nerve in the ANS (autonomic nervous system) with lots of fancy diagrams.
The rest of the talk seems to me like a sales pitch for the vagal stimulation instrument which costs over $1000. She says it's had marked effects on various symptoms for her, and 5 other people tried it and agreed to share their responses to some fatigue and symptom questionnaires. She shows graphs of their responses, which are very unconvincing that there was any significant effect, with two out of the 5 having no effect or getting worse, and the other three having slight effects.
She ends by repeating that this is not scientific research, and research is needed.
So to me, it's an unscientific sales pitch or personal anecdote, I can't decide which.
The presenter is an OT who has had several short bouts of PVFS/ME lasting from a few months to a current bout of over a year severe, now mild and back at work. She has tried lots of different treatments, including nutrients, probiotics, meditation, therapy, etc. and a very expensive instrument that you clip on a specific part of the ear to stimulate the vagus nerve. She is enthusiastic about all the different treatments, claiming they all helped her.
She builds in lots of caveats that she is not a scientist and is not doing research, then proceeds to try to invent hypotheses based on a superficial view of Naviaux cell danger response hypothesis and ANS overstimulation, and talks about the role of the vagus nerve in the ANS (autonomic nervous system) with lots of fancy diagrams.
The rest of the talk seems to me like a sales pitch for the vagal stimulation instrument which costs over $1000. She says it's had marked effects on various symptoms for her, and 5 other people tried it and agreed to share their responses to some fatigue and symptom questionnaires. She shows graphs of their responses, which are very unconvincing that there was any significant effect, with two out of the 5 having no effect or getting worse, and the other three having slight effects.
She ends by repeating that this is not scientific research, and research is needed.
So to me, it's an unscientific sales pitch or personal anecdote, I can't decide which.
Snowdrop
Senior Member (Voting Rights)
I find it hard to imagine being severe and having the energy to attempt so many types of therapy.
I appreciate all the caveats but it always seems to my reading that these are more about anticipating criticism than any real belief that the hypothesis might not be true.
We seem to be wired for wanting to solve/understand things yet at the same time lack an appreciation for the need for mastery of necessary knowledge. I've certainly been guilty of this.
I appreciate all the caveats but it always seems to my reading that these are more about anticipating criticism than any real belief that the hypothesis might not be true.
We seem to be wired for wanting to solve/understand things yet at the same time lack an appreciation for the need for mastery of necessary knowledge. I've certainly been guilty of this.
Penelope McMillan
Established Member (Voting Rights)
It's a personal anecdote. Right now, the increasingly large group of local people who are experimenting with TVNS (Transcutaneous Vagus Nerve Stimulation) are working on use of TENS machines for the same purpose, at a hugely smaller cost. It is a pitch for TVNS, not for the Parasym. There are still some kinks in the TENS approach, as the machines are not designed for this purpose. For me, one great advantage of the Parasym is that it is extremely easy to use the settings, because they are designed for TVNS.
The five people in the original group are all still using the Parasym and reporting increasing benefits. Given that for tinnitus, TVNS takes months for full effect, it seems reasonable that TVNS for ME may also demonstrate effects over time. (I have yet to use the tinnitus treatment - the literature suggests that TVNS can be curative for tinnitus, so it's on my to-do list.)
Interestingly, as the size of the experimenting group has expanded, the range of symptoms reported as being affected in a helpful way has increased.
One of the reasons the size of the experimenting group has increased is because people can literally see the difference in those of us using the Parasym. Apparently we "look better". I have also had occasional comments from people outside the ME community, for example, "I can see in your face that you're doing something different. What is it?" (from a researcher) or "I watched you get up from that chair. You're more agile. What's going on with your health?" (from a fellow health advocate).
For me personally, the biggest difference has come with finding my own effective dose, which is much higher than I have found in any TVNS or VNS literature for any condition. I use my Parasym three times a day, for an hour each time. The setting I use is designed to increase parasympathetic nervous system activation, and thus also to reduce sympathetic system activation.
Overall, for me, the Parasym has dampened all my symptoms. This does mean that when I choose to, I have more capacity to be active, which is a danger as I still get the PEM. Having said that, the PEM is less distressing because the symptoms remain less severe.
The dampened symptoms mean that resting has actually become more restful, which is a massive daily benefit to me.
I feel that in the longer term I should experience greater benefits, directly and/or indirectly. Even something as simple as sleeping better, surely will have a positive effect over time. (Except for nights when I have pushed myself into PEM, I am sleeping in longer stretches of time instead of waking frequently; and I feel as though I have a better quality of sleep.)
The research in other conditions indicates that for TVNS the only reported side effect is irritation at the site of connection for some people. Certainly, the ear clip is annoying. But I've become used to it. (Parasym offers "hard" and "soft" ear clips. We've been very clear that anyone with ME or Fibro ought to be sent the soft clip - they seem to be getting the message.) Compared to the way pwME so often struggle to tolerate drugs, this therapy feels low risk. And not one of my specialists has indicated any concern that the TVNS might interact with my current prescription drugs.
I would add that for use in ME, there needs to be a caution that just because you can do more, this does not mean that it is necessarily safe for you to do more.
How to summarise my experience? My life is much, much more comfortable. I have experienced significant reductions in some symptoms. I do not feel as though the underlying issue of limited total capacity has been affected, yet I consider there is perhaps some potential for improved capacity in the longer term.
Thanks, @Penelope McMillan. That's very interesting. Is there a properly registered scientific clinical trial?
David Kem at the University of Oklahoma appears to have plans to launch a well-controlled trial on the use of a TENS device in the treatment of POTS and to see if it affects production of alpha-adrenergic receptor autoantibodies.
https://clinicaltrials.gov/ct2/show/NCT03930914
I know POTS is not ME, but they bear some similarities to each other.
https://clinicaltrials.gov/ct2/show/NCT03930914
I know POTS is not ME, but they bear some similarities to each other.
Penelope McMillan
Established Member (Voting Rights)
We have yet to get a researcher interested in supervising a formal trial. We are working on it!
In the meantime, our experiences should be very useful in study design, as researchers need to select settings and doses for trial.
Penelope McMillan
Established Member (Voting Rights)
Thanks for that. I have emailed Katlyn.
Many of us with ME have POTS and I have certainly noticed changes since using the Parasym. My heart rate escalates more slowly and my safe upright time is longer.
It is extremely unlikely that they plan to trial the three hours a day that I have found to be optimal for me.
Penelope McMillan
Established Member (Voting Rights)
Regardless of the hypothesis, those of us using TVNS love it.
I have just had a phone call from someone wanting help to set up her new device, after dropping her original one down the loo.
She was very keen to describe to me those symptoms that had become worse again during her two weeks without TVNS. She emphasised her communication skills, sleep, and clarity of thought.
She compared the money she spent on a Parasym to the money she spends on supplements - she considers her Parasym to be unquestionably effective and good value for money.
The knowledge we are acquiring through experimentation will hopefully be helpful to researchers who set up formal trials.
What we can assert with some authority is that the people in our experimenting group would not give up their TVNS without a fight. Every person appreciates the small but significant changes it has brought to their life.
Penelope McMillan
Established Member (Voting Rights)
It's worth noting that the Parasym is not available everywhere. So it will be helpful if the TENS approach can be sorted out.
In the UK you can only get a Parasym with a prescription, which I doubt includes use for ME. The price structure for a prescribed Parasym in the UK is different, too.
And in North America, FDA approval is still pending.
In the UK you can only get a Parasym with a prescription, which I doubt includes use for ME. The price structure for a prescribed Parasym in the UK is different, too.
And in North America, FDA approval is still pending.
Sly Saint
Senior Member (Voting Rights)
according to their website you can buy one online for £599 from UK.
Can't see any restriction re prescription.
eta: you can also rent one for £39.99 pm
Rain
Senior Member (Voting Rights)
@Penelope McMillan have any of you tried the new device from Cerbomed called VITOS? The price is significally lower than NEMOS. (I assume that will change as soon as it is officially considered a Migraine treatment device.)
Penelope McMillan
Established Member (Voting Rights)
Not that I am aware of.
The problem, as far as I can tell from the web, it that both Nemos and Vitos are preset for specifically epilepsy and migraine. They are at 25Hz and 1Hz.
We are using 20Hz.
With the Parasym, I can use a variety of settings.
For example, the tinnitus setting is very different from our parasympathetic setting.
Also, the 1Hz for migraine, for example, is based on a study that used 1Hz. If future studies trial different settings and find them to be superior, the gadget appears not to be programmable by the user.
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I would be curious to find out whether this ‘treatment’ produces a placebo effect, hence it would be important in the study design that there is randomized recruitment, with a sham treatment arm. We do know that such trials are expensive and patients purchasing their own devices would already show allegiance or inclination to treatment effectiveness, so it would seem essential that the device is provided.
In the end, we need biomarkers and researchers may well be looking at that instead of treatments trials that are not likely to show big effects compared to placebo.
In the end, we need biomarkers and researchers may well be looking at that instead of treatments trials that are not likely to show big effects compared to placebo.
Penelope McMillan
Established Member (Voting Rights)
Placebo in other conditions has been carried out by placing the clip on the ear lobe rather than the tragus, which assumes that the trial participant is unaware of correct clip placement. As TVNS becomes better known, this placebo approach may no longer be workable, which will complicate studies.
In terms of expense, compared to experimental drugs, TVNS is not expensive. I've been in drug studies for other conditions and the Parasym is dirt cheap in comparison. That alone doesn't make a formal study cheap, of course.
(I discovered recently that my government subsidised asthma meds are worth more than $AUD20K pa. The Parasym at a one-off cost of $AUD1,200 is very cheap.)
Perhaps the comments of people who have known me for years, but who had no idea that I was trialing a new treatment, could be considered a form of blind measure. It is clear that I look and move differently.
Also, although neither blind nor objective, people in our experimental group are reporting effects that were entirely unanticipated. For example, several women have independently reported a decrease in urinary incontinence.
In other conditions, objective outcome measures for TVNS have included brain imaging that has shown neuromodulation. Given that our experimental group is in South Australia, where studies have shown identifiable differences between the brains of people with ME/CFS (CCC) and those with MS, depression or healthy controls, we are keen to get more brain imaging researchers involved in new studies anyway. It is too late to do before and after TVNS use on our group, but it could be done for others. And some of our group do have historical research brain scans for comparison. Real time observation of neural activity under TVNS can be done, of course, although observations tend to be complex (see for example, https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0207281).
Our small experimental group is only using measures that people in the group already use, such as heart rate and heart rate variability. These measures aren't blind, of course, but they are objective. Edit: also sleep measures, of course.
In terms of not showing big effects, I would personally describe the effects for me as huge.
On one occasion, I stood at an event for twenty minutes. That was after sitting up for about forty minutes! My usual standing limit, on a good day and after lying down, is ten minutes. Medication got me from zero up to ten minutes; TVNS has lifted that significantly.
Another big effect was on my visual tolerance. I could not tolerate moving images that were were not "natural", such as titles or animations. They caused me pain, dizziness and nausea. Since TVNS, this has improved so much that I am watching animated films. (From 'Frozen' to 'A Scanner Darkly', I feel as though I am back in the cultural reference mainstream!)
I know that Andrea's video and the testimony of people like myself seem almost evangelistic. We have a highly distressing and disabling condition for which there are no approved treatments. None of us are claiming that TVNS has cured or will cure our ME. But we are claiming that it has changed our lives and that we would hate to be without this therapy. We want others to know that it is available and we want researchers to take an interest. It has taken a long time for LDN to move from peer supported experimentation to formal evaluation. We don't want to wait that long.
Interesting what you say about being able to stand for longer @Penelope McMillan. That piqued my interest as I struggle to stand for 10 minutes. I saw what you said about just because you can do more it doesn’t necessarily mean it’s a good idea. Did you get PEM after standing for 20 minutes?
Penelope McMillan
Established Member (Voting Rights)
Yes, I get the same PEM as if I had struggled to do whatever I have done, in terms of when it hits, how severe the PEM is, and how long it takes to resolve. So yesterday I made the same mistake, too much standing around at an event instead of always sitting with my feet up (I carry a footstool for my feet). It's so much harder to be careful when I feel OK! Later last night I felt dreadful, today I am flat, and I fully expect tomorrow to be rough.
However, the PEM symptoms are not as strong. It's hard to explain, as I am still definitely in PEM. But for example, I am less likely to have that feeling of an icy burn on my skin, I have a much lower sense of being wired, the tinnitus won't be as extreme, etc. I still feel depleted and struggle to do anything. It is PEM. But it's a bit more comfortable than I would historically have expected.
I hope that makes sense?
Yes I think it does. I have gradual onset ME that goes between mild and moderate so I have better and worse spells where my limits seem to vary and PEM can be less bad sometimes. And yes it can be almost more difficult to keep things steady when you’re having a better day and you end up going way too far over limits.
I have just come across a related article in medium.com about the vagus nerve, which mentions a 2016 paper reviewing the research on the Vagus Nerve. I can't access the full paper and wondered if anyone had access to the full article?
The article also has a link to American Headache Society article on FDA approval for a VNS device)
I recently watched Dr Michael vanElzakeer talk about the role that the Vagus nerve might play in ME, so I was interested to see what else is here in s4me on VNS. And found this thread.
I appreciate @Penelope McMillan that you have explained how VNS has helped you, but also not reduced the PEM. Still, improvements to daily life.
I see that Dr vanElzakker suggests in his Q&A video (thread here) that VNS has caused migraines in some pwME, so obviously some care is needed.
fyi The video that this thread was initiated for is no longer available. Perhaps this is where it has been moved to? i.e. under Andrea Parker's own youtube account.
The article also has a link to American Headache Society article on FDA approval for a VNS device)
I recently watched Dr Michael vanElzakeer talk about the role that the Vagus nerve might play in ME, so I was interested to see what else is here in s4me on VNS. And found this thread.
I appreciate @Penelope McMillan that you have explained how VNS has helped you, but also not reduced the PEM. Still, improvements to daily life.
I see that Dr vanElzakker suggests in his Q&A video (thread here) that VNS has caused migraines in some pwME, so obviously some care is needed.
fyi The video that this thread was initiated for is no longer available. Perhaps this is where it has been moved to? i.e. under Andrea Parker's own youtube account.