Vagus Nerve Stimulation in Fibromyalgia and ME/CFS: A Trial of One

Discussion in 'General' started by Cort, Dec 8, 2016.

  1. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    An Emerging Treatment

    My interest in vagus nerve stimulation was prompted by a number of factors. Fibromyalgia (FM) and/or chronic fatigue syndrome (ME/CFS) studies indicate that reduced heart rate variability - a sign of vagus nerve withdrawal - was not just present in these diseases, but was associated with poor sleep and reduced cognition in them. Other studies indicate that sympathetic nervous system activation - a sign of vagal withdrawal - is common in all the diseases associated with ME/CFS and FM; e.g. irritable bowel syndrome, interstitial cystitis, migraine, and Gulf War Illness. The fact that low heart rate variability is associated with a higher risk of death even in healthy individuals was a bit of an eye-opener as well.

    Vagus-Nerve.jpg
    There was my firm conviction that the "arousal" that has been with me from day one must has its roots in sympathetic nervous system activity. It was a small fibromyalgia study, though, that really piqued my interest. That study - which involved surgically implanting a vagus nerve stimulator in the neck - caused the usually pretty buttoned-down Dr. Ben Natelson to state “The results blew me away. I have never seen an effect as powerful as this.”

    In a year Jean Hasse went from being bedbound and on high doses of opioid painkillers (clearly not working!) to getting her Master's degree and regularly exercising. Many of the FM patients in the small study no longer met the criteria for FM at the end of it. The study was far too small to be definitive but these were extraordinary results. Another remarkable story concerned a woman crippled by a severe case of rheumatoid arthritis who was able to resume her normal activities.

    · Reborn: Reversing Fibromyalgia with Vagus Nerve Stimulation

    Natelson is currently involved in a Gulf War Illness study using a non-invasive ear-attached vagus nerve stimulator (VNS) that he believes may be every bit as powerful as the surgically implanted one. (Interested in being in the study? GWI patients contact Sara Tom in New York: 212-844-6665, stom@chpnet.org.)


    Vagus Nerve Stimulation

    Vagus nerve stimulation isn’t new at all; it's been used for many years in epilepsy. What's new are attempts to use it in other diseases. Clinicaltrials.gov When epileptics reported their pain was diminishing as well as their epilepsy symptoms, researchers began considering it for chronic pain conditions.

    Today Clinicaltrials.gov lists 33 open vagus nerve studies, most of which are testing non-invasive vagus nerve stimulation devices. Invasive and non-invasive vagus nerve stimulators are being trialed in diseases ranging from Crohn's disease to migraine, epilepsy and depression. Attempts are being made to increase gastric motility and reduce inflammation in epilepsy, to reduce pain and migraine in Gulf War Illness, to reduce pain in esophageal disease, lupus, and following operations, and in adolescents with "functional" abdominal pain and/or nausea.

    Chronic pain is clearly a major target of VNS studies. VNS may be effective with chronic pain because it may be able to reduce inflammation, oxidative stress, autonomic nervous system activity, the opioid response, central sensitization, and pain perception. Jean Hasse's underactive vagus nerve may have prevented opioids from working well for her. VNS stimulation also appears to help the nervous system unlearn the "windup" activity that plays such an important role in central sensitization.


    VNS may also be able to reduce neuroinflammation in the brain. A recent mouse study indicated it reduced cytokine levels and microglial activation in the brain. Given all that, it was perhaps no surprise to see a recent review of VNS studies in mood disorders call the results "promising".

    I've never thought the wiredness, arousal, hypervigilance, anxiety or whatever you want to call it that I've associated with ME/CFS was other than something physiological in nature. It was too constant and too difficult to tame for it be otherwise. It seemed to come baked in with my muscle stiffness, racing heart and post-exertional malaise.


    Touchy System

    In Dr. Pocinki's superb 2012 "Dysfunction Junction" article for The Solve ME/CFS Initiative he describes a supremely touchy system which, as Workwell's Staci Stevens has noted, just really doesn't how to behave.

    Pocinki's in-office tests indicate overshoots by both sides of the autonomic nervous system, the SNS and the PNS, occur regularly. Acute stressors can produce a SNS surge followed by an even more excessive parasympathetic rebound that leaves one nauseous, sweating, lightheaded, with diarrhea and more fatigue. If you feel physically jacked up and bothered by small emotional or physical events and then depleted afterwards, this could be the reason.

    Even being in a resting state can be too much for a fragile ANS system which flops around trying to find its mean. Deep breathing should bring on a nice parasympathetic nervous system (PNS) surge but Pocinki found that the initial PNS surge caused a large SNS reaction followed by another PNS surge.

    Chronic stresses, on the other hand, stimulate the sympathetic nervous system (SNS) leaving one feeling "wired and tired" and jittery.

    From fatigue, to exercise problems, gut problems, cognitive problems, sleep, the ANS, which is also an important immune regulator, could affect them all.

    A Trial of One

    So when a very generous person offered to let me try the non-invasive Cerbomed device (available only in Europe), I jumped at it.

    The Cerbomed Device



    The
    Cerbomed device is not available for purchase in the U.S. yet. Cerbomed informed me earlier this year that they expected to get it approved for use this year. It simply consists of a small box which electrodes attach to which then get placed in one's left ear right underneath the fold in the section identified as AVBN in the picture.

    Cerbomed recommended using the device up to 4 hours, but I was told by two people who have tried it that it's very powerful and going too far too fast can really wipe you out. Of the two people I know who have tried it, one is able to exercise for the first time in decades. The other has had some benefit but nothing near that.

    My Trial

    • Day 1: 30 minute session - I noticed a feeling of warmth, fullness and relaxation during the 30 minute first stimulation (at the lowest level); after it ended feelings of mild anxiety (hyperarousal) returned.
    • Day 2: 30 minute session - I noticed a strong feeling of increased relaxation, increased mental clarity and well-being. This time it persisted throughout the day and into next day. I was able to walk further that morning than I can remember without pain. Throughout the day the feelings of increased strength, relaxed muscles and mental clarity persisted - and into the night - when I talked with a friend on a video hangout at about 10 pm...
    • Day 3: the next day I woke again with a feeling of stillness I am really very unacquainted with. Went for another walk (morning is my worst time of day to walk) still feeling more energized.
    • The Next Ten Days: I did the stimulator only for short periods (10 mins/twice a day) during the next week because I was going to give blood for Dr. Naviaux's study. Then three days ago, after I woke up at 3:30 a.m. feeling miserable, I cranked it up (still at the lowest level) for 30 minutes and responded well again. Despite a rather difficult day, my muscles felt relaxed, I had more energy, etc. Two days later remnants of that boost remain.
    Not Representative

    This clinical trial of one is hardly representative because I am hardly representative. I've been diagnosed at one time or the other over the last 30 years with both chronic fatigue syndrome (ME/CFS) and fibromyalgia. My main symptoms are fatigue, post-exertional malaise, chemical sensitivities, cognitive issues, some gut problems and pain. I'm probably much better off than most and am not on any drugs.

    I'm unusual, though, in that I tend to respond very quickly to treatments, build up my energy and then CRASH. For the first 15 years or so I didn't respond to anything. Now I tend to respond rapidly but as my energy builds I get more and more flu-like symptoms.

    Vagus nerve branch - ear (ABVN).PNG
    Typically, and this has happened many times, not long after I start feeling clean bursts of energy, the tendons inside my elbows (oddly enough) start aching, I get fluey and exhausted, my feet start sweating, I get jittery and the energy boosts stop. This has been happening to me for about 20 years. (In a recent discussion Dr. Naviaux proposed why that may be happening. That blog will be up shortly.)

    I'm therefore a bit unusual, plus we all know how incredibly variable responses to treatments are in both fibromyalgia and chronic fatigue syndrome. It took three weeks for the device to start having effects in the other person I know the device worked for. If the device works the effects build over time.

    I don't know if this will work for me. I rather think my typical reaction to energy boosting and relaxing treatments will eventually knock it out. This has been, however, the most powerful response to a treatment that I can remember. It certainly suggests that an under-active vagus nerve plays an important role in my disease. It also suggests that the difficulty concentrating, the "rushing mind", the fatigue and PEM, the stiff, contracted muscles, and the cognitive issues are all of a piece. The whole universe of symptoms associated with being perennially wired and tired are all connected together.

    Device Availability and Other Resources

    The Cerbomed device, which is available only in Europe, at present, is very expensive (@$4000). Both GammaCore and Cerbomed, I believe, are attempting to get their devices licensed in the U.S.

    Two much less expensive ($650 and $280) non-invasive vagus nerve stimulators are available in the U.S. Some studies have been done on one and none on the other. I have no idea if one device is better than the other or not. Check out available vagus nerve stimulators here.

    Check out more resources including blogs and other ways to increase vagus nerve activity in our Vagus Nerve and Vagus Nerve Stimulation Resource section.

    Health Rising's Big (Little) Donation Drive Is On!

    Vagus nerve problems and vagus vagus nerve stimulation are just two of the many possibilities you probably would have never come across if it were not for Health Rising.To put it plainly, Health Rising relies on donors like you to exist. We need little compared to research efforts but we, too, have (very, very modest) salaries, upkeep, server and software costs, etc. to keep with.

    Please keep the information flowing by contributing to Health Rising. $5 recurring donations are our lifeblood; you probably won't even notice them - but I assure you that we will. Find out how you can contribute here.
     
    Last edited: Dec 12, 2016
  2. Remy

    Remy Administrator

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  3. rebar

    rebar Active Member

    I googled the price, it's 3,900 euros.

    WOW, must make cappuccino too.

    I would truly love to try the cerbomed nemos but at over 4000. dollars, I can wait.

    Also, @Remy can you make a technical comparison between the two, is the technology similar?
     
    Last edited: Dec 9, 2016
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  4. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    I would like to know that. The Cerbomed device allows you to deliver differ levels of electrical stimulation to the ear and it has a timer, it tells you if the electrodes are properly inserted and stuff like that but I don't know why it is soooooo expensive.
     
  5. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    The Nervana devices uses headphones while the Cerbomed device uses electrodes. Other than that I don't know. I've been told the technology is pretty simple.

    Perhaps the Cerbomed is more expensive because they're doing studies to gain approval for its use?
     
  6. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    I didn't realize I had a resource for devices - one other one is available in the States. You can find that list here - http://www.healthrising.org/forums/resources/non-invasive-vagus-nerve-stimulating-devices.296/

    I also added a section to the blog on Pocinki's very interesting ANS talk.
     
  7. rebar

    rebar Active Member

  8. Remy

    Remy Administrator

    It seems similar to me...Nervana is an electrode too, but it's connected to headphones so you can time it to music or use it on silent mode. It also targets the vagus nerve through the left ear.

    So...I don't know if they are different or what justifies the price difference, honestly.

     
  9. Prashanti

    Prashanti Member

    I am very interested in this. I have access to the alpha-stim device which you use on the ear lobes and had thought about clipping it on the section of the ear that the vagus stimulators use. However, I am not certain about the type of stimulus it emits. I think I will try it. If I notice anything I will post it.

    I have been using the alpha-stim to check it out and find I have more energy. However, it can make me feel anxious even though I am using it on the lowest intensity. So I can't use it daily. I do notice less pain in the body with the alpha-stim.

    I have talke to several companies of these stimulator devices: alpha-stim, Fisher Wallace, Thync, CES and neurofeedback devices. No one seemed to be able to tell me specifics about the stimulator device's wave forms, etc and why they worked or differed from each other. So I wonder does it matter? Is any type of stimulation effective?

    I have also tried just massaging the area of the ear for the vagus stimulation. It is often quite sore until I have massaged it for several days.
    I've done a little survey with friends asking those with and without digestive issues to massage that section of the ear. So far those with digestive issues have more tenderness or sensitivity on the ear than those that have no digestive issues.
     
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  10. Joya Skye

    Joya Skye Member

    YES! Oh, YES! I have believed that was the solution for several years now! I have known for a long time that this was an ANS problem. I believe everything else is secondary. I have been going nuts like in the POTS article they discuss the ANS and then dismiss it. Because the solution is simple and shouldn't be expensive!

    I think the reason the device to write about is so expensive is just because they can. Sorry, but I am getting cynical about the medical establishment. I have received no help and much condem nation from them.

    When I read the POTS article I thought, well these are all symptoms I have. So, it appears I have all these illnesses. ME, CFS, fibromyalgia, POTS. The symptoms are all pretty much the same to varying degrees and differ from person to person.

    My very first symptom was insomnia, brought on by developmental trauma repeated in a bad marriage and bam, I was sick. I have gone through all sorts of new and repeated symptoms throughout the years, but the insomnia and hyper vigilance has been with me all this time.

    I bought and worked with a stimulation device for two years, but the guys could never find the right settings for it to work. We tried lot of them. I saw the Fisher-Wallace, but it was much more expensive. I don't think it is any better.

    I am so sick of being "wired and tired" all the time! I have managed a lot of the other symptoms, but never that. I take lots of meds to sleep and still barely do. Especially if the EMF's or electricity is too high where I am sleeping. All of this has drained my finances an left me feeling like checking out.

    Oh, I hope one of the less costly instruments will work! I am so grateful for your work, Cort. The articles have sometimes made me feel more hopeless, but this one gave me hope!

    Thank you!
     
    Last edited: Dec 9, 2016
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  11. DebbieK

    DebbieK New Member

    I have tried the Fisher-Wallace stimulator and it didn't work for both myself and my boyfriend(we both have very similar forms of fatigue issues)-was too energizing even at the lowest setting-made our insomnia worse, would get too hyper during the day and then crash. We both reacted pretty much the same to it. But the company was good to their word and refunded our money minus a restocking fee so we were glad we had tried it. Everyone is different and it has some good reviews. I'm very interested in trying a vagus nerve stimulator as well.
     
  12. fdotx

    fdotx Well-Known Member

    Is this product mainly for those who feel wired but tired or could it also work for only fatigue?
     
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  13. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    How long do you use it Prashanti? I'm using the Nemo's device at 0.1 amps (?) - the lowest setting - for from 10 minutes to 30 minutes.

    There are clearly lots of questions to be answered. A POTS study has looked at one; they said they had to create their own device!
     
  14. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Thanks Joya, For me this thing goes right at the wired and tired feeling and everything that comes with it - which my experience with Nemos suggests is mostly everything!

    I hope you can find something that works...
     
  15. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    I don't know. The stimulators are being tried in a wide variety of illnesses for different things such as pain and gut issues. It's helped people with FM who are in pain - I don't know if they are wired and tired as well.
     
  16. rebar

    rebar Active Member

    I look forward to hearing about your experience Remy.
     
  17. Nita

    Nita Member

    I wonder how this is different from a $30 TENS Unit with electrodes that one can buy for muscle nerve stimulation on Amazon?
     
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  18. rebar

    rebar Active Member

    Last edited: Dec 10, 2016
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  19. Paw

    Paw Well-Known Member

    Remy, I can't wait to hear your reportage re your Christmas present.

    Cort, thanks for the thorough write-up, not only on your experiences with the Cerbomed, but also your general profile. You say you're atypical, but you might as well be describing me in almost every detail. (My achy tendons during PEM are more in the shoulders and hips than the elbows -- making it almost impossible to sleep on my side.)

    I have been diagnosed with autonomic neuropathy (as well as small-fiber and peripheral), and I've long suspected that's the key to all my problems -- sleep, blood pressure, gut, RLS, burning pain, energy production, etc.

    Every once in awhile, maybe after a particularly good night's sleep, I feel a rare form of energy coursing through my entire body, into my muscles, tendons, cells, etc. It seems to me what human energy naturally ought to be. It makes me feel strong, relaxed, and mentally clear. It is pleasurable to live inside my body.

    Instead, my usual energy feels like simple adrenaline, or "stress" (even if I'm not "stressed out" about anything). It's short-lived, leaves me wiped out after a couple of hours, and never seems to get to the cells in my body. I am capable of fully relaxing, but only into an awareness of a constant low-level burning and aching. Stimulants merely exaggerate that pattern. If I don't lie down and rest -- if I push through with something -- then a total "flu state" follows. Regular exercise is systemically helpful, but comes with high levels of joint, muscular, and myofascial pain.

    How wonderful it would be to activate that elusive cellular-level energy with a $300 device!
     
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  20. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Yes, indeed. Those feelings of being strong, relaxed and mentally clear are what I associate with the Nemos device and indeed all things that have worked - at least temporarily - for me.
     
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