Gulf War Illness Vagus Nerve Trial Could Pave Way for Fibromyalgia

Cort

Founder of Health Rising and Phoenix Rising
Staff member
[fright]
Natelson_Benjamin_11.jpg
[/fright]Dr. Benjamin Natelson is a pretty conservative guy; he's known to be a careful researcher but even he had trouble controlling his enthusiasm at the results of his and Dr. Lange's small vagus nerve stimulator fibromyalgia trial. Natelson has been studying and treating fibromyalgia and chronic fatigue syndrome for many years - he'd even lead an NIH sponsored ME/CFS research center at one poinit - but he'd never come across anything like this:
“The results blew me away. I have never seen an effect as powerful as this.” Dr. Benjamin Natelson
One participant's story bears the repeating:
A former high school science teacher, Hasse’s journey with FM/ME/CFS began when she experienced knee pain during pregnancy. The pain spread to her ankles, then to her hips, then into her smaller joints and finally everywhere including her skin. She couldn’t move or experience touch without pain, had severe brain-fog, and was diagnosed with irritable bowel syndrome. She ended up leaving her job and was bed bound most of the time.

Cymbalta didn’t help. Lyrica did but also caused her to gain a lot of weight. Relaxation techniques including tai-chi helped keep her calmer but didn’t substantially reduce her pain. Tramadol helped but she was up to 16 tramadol a day prior to the VNS.

Jean went from being bedmbound to attending graduate school and going back to work over a year. About half the patients in the study had a similar result.
That study was published FIVE long years ago. If any study deserved a follow up it was that one, but the NH - looking only for studies that elucidate "mechanisms of action", turned down Natelson's application for an expanded study. Natelson was stumped - he had a potentially superb treatment for a difficult to treat disease but no way to pay for a clinical trial.

When a Department of Defense grant opportunity asking for "novel treatments" for Gulf War Illness (GWI) - a disease with similar symptoms as fibromyalgia - Natelson was ready. He applied and got a grant to do the study. That means that GWI patients will get the first shot at non-invasive vagus nerve stimulation in the U.S., and truth be told, after being ill for decades, if anyone deserves it they do.

If the GWI study goes well, Natelson will try and circle back to do a fibromyalgia study That's, the same strategy Dr. Klimas has used to great effect with ME/CFS; first she proved something in GWI and then uses her GWI findings to help her get ME/CFS grants.

None Invasive Stimulator

[fleft]
Vagus-Nerve.jpg
[/fleft]The other 'breakthrough" in this story involves the development of a non-invasive vagus nerve stimulator. Natelson used a surgically implanted stimulator which runs a cool 20K - if you can find someone to put it in - i n the first FM study. Vagus nerve stimulators that you clip to your earlobe or put on your neck, however, have been available in Europe for awhile, and are coming to the U.S.

Dr. Natelson believes these stimulators may be as effective as surgically implanted stimulators - and would be, of course, much cheaper. The company producing the stimulator has applied for FDA approval in the U.S. If it's successful it will be the first device of this type approved in the U.S.

The GWI trial simply involves placing the device (or a sham device) against one's neck six times a day for 120 seconds for ten weeks. All participants will use both the real and sham devices. The study will assess body-wide pain and headache/migraine.

This device has already been shown to be effective against migraine, where in an interesting twist, it became more effective the longer one used it. After six months migraine sufferers experienced an average reduction of eight fewer migraine days a month. About 40% of the patients in the trial experienced a 50% reduction or more in the frequency of their migraine attacks.

GWI, FM, ME/CFS studies have also shown that reduced parasympathetic nervous system activation (think vagus nerve) and increased sympathetic nervous system activation (SNS) (fight/flight) is present, and its been tied to increased pain, poor sleep and poor cogntion.

If you have GWI the reason to enroll in the study - a possible breakthrough in your health - is obvious. If you have FM/ME/CFS the reason to spread this as far and wide as possible is in order to get the next VNS fibromyalgia study going as quickly as possible. Dr. Natelson is only researcher I know of who is doing vagus nerve stimulator studies in FM/ME/CFS.

It took Dr. Natelson a year to get approval for this study but the hardest part is often patient recruitment. Let's get this study filled as quickly as possible. It's taking place in three centers in New York City and New Jersey.

Study Locations

New Jersey
  • East Orange Veterans Administration Medical Center
New York
  • Mount Sinai Beth Israel Hospital
  • Pain and Fatigue Study Center - Beth Israel Medical Center
Contact:


Diana Vu, BA
212-844-6747 dvu@chpnet.org

Brain Imaging Study

Dr. Natelson is also beginning a Gulf War Illness brain imagining study which he believes may produce a biomarker. In this study Natelson will use brain imagining to analyze the chemistry of GWI and healthy veterans brains. He believes the study will produce an immune biomarker. He will also assess the levels of inflammation in the brain using a new brain imaging technique.

Contact:
Benjamin H Natelson, MD:
212-844-6665 bnatelson@chpnet.org
 
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Issie

Well-Known Member
Sounds promising. Years ago my sis checked into getting one, it wasn't covered by insurance because it would have been considered off label or research. Would be great if we could get the external device. Sign me up.

Years ago, I researched GWS. So much of it fits with me. But I didn't go to war. But I was exposed to lots of toxic chemicals in the air, pesticides and vaccines that I reacted to. Makes one think......

Issie
 

Lemnia

Member
[fright]View attachment 1993 [/fright]Dr. Benjamin Natelson is a pretty conservative guy; he's known to be a careful researcher but even he had trouble controlling his enthusiasm at the results of his and Dr. Lange's small vagus nerve stimulator fibromyalgia trial. Natelson has been studying and treating fibromyalgia and chronic fatigue syndrome for many years - he'd even lead an NIH sponsored ME/CFS research center at one poinit - but he'd never come across anything like this:


One participant's story bears the repeating:

That study was published FIVE long years ago. If any study deserved a follow up it was that one, but the NH - looking only for studies that elucidate "mechanisms of action", turned down Natelson's application for an expanded study. Natelson was stumped - he had a potentially superb treatment for a difficult to treat disease but no way to pay for a clinical trial.

When a Department of Defense grant opportunity asking for "novel treatments" for Gulf War Illness (GWI) - a disease with similar symptoms as fibromyalgia - Natelson was ready. He applied and got a grant to do the study. That means that GWI patients will get the first shot at non-invasive vagus nerve stimulation in the U.S., and truth be told, after being ill for decades, if anyone deserves it they do.

If the GWI study goes well, Natelson will try and circle back to do a fibromyalgia study That's, the same strategy Dr. Klimas has used to great effect with ME/CFS; first she proved something in GWI and then uses her GWI findings to help her get ME/CFS grants.

None Invasive Stimulator

[fleft]View attachment 1991 [/fleft]The other 'breakthrough" in this story involves the development of a non-invasive vagus nerve stimulator. Natelson used a surgically implanted stimulator which runs a cool 20K - if you can find someone to put it in - i n the first FM study. Vagus nerve stimulators that you clip to your earlobe or put on your neck, however, have been available in Europe for awhile, and are coming to the U.S.

Dr. Natelson believes these stimulators may be as effective as surgically implanted stimulators - and would be, of course, much cheaper. The company producing the stimulator has applied for FDA approval in the U.S. If it's successful it will be the first device of this type approved in the U.S.

The GWI trial simply involves placing the device (or a sham device) against one's neck six times a day for 120 seconds for ten weeks. All participants will use both the real and sham devices. The study will assess body-wide pain and headache/migraine.

This device has already been shown to be effective against migraine, where in an interesting twist, it became more effective the longer one used it. After six months migraine sufferers experienced an average reduction of eight fewer migraine days a month. About 40% of the patients in the trial experienced a 50% reduction or more in the frequency of their migraine attacks.

GWI, FM, ME/CFS studies have also shown that reduced parasympathetic nervous system activation (think vagus nerve) and increased sympathetic nervous system activation (SNS) (fight/flight) is present, and its been tied to increased pain, poor sleep and poor cogntion.

If you have GWI the reason to enroll in the study - a possible breakthrough in your health - is obvious. If you have FM/ME/CFS the reason to spread this as far and wide as possible is in order to get the next VNS fibromyalgia study going as quickly as possible. Dr. Natelson is only researcher I know of who is doing vagus nerve stimulator studies in FM/ME/CFS.

It took Dr. Natelson a year to get approval for this study but the hardest part is often patient recruitment. Let's get this study filled as quickly as possible. It's taking place in three centers in New York City and New Jersey.

Study Locations

New Jersey
  • East Orange Veterans Administration Medical Center
New York
  • Mount Sinai Beth Israel Hospital
  • Pain and Fatigue Study Center - Beth Israel Medical Center
Contact:
Benjamin H Natelson, MD:
212-844-6665 bnatelson@chpnet.org

Diana Vu, BA
212-844-6747 dvu@chpnet.org

Brain Imaging Study

Dr. Natelson is also beginning a Gulf War Illness brain imagining study which he believes may produce a biomarker. In this study Natelson will use brain imagining to analyze the chemistry of GWI and healthy veterans brains. He believes the study will produce an immune biomarker. He will also assess the levels of inflammation in the brain using a new brain imaging technique.

Contact:
Benjamin H Natelson, MD:
212-844-6665 bnatelson@chpnet.org
Really interesting. I'm in Europe, does anyone know who supplies it and the name it goes by? I'd be interested in trying it.
 

cherubim

Well-Known Member
Is there any way to "simulate" the device Dr. Natelson used - such as a TENS/ micro current machine?
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
Me too given my chemical sensitivities.
Sounds promising. Years ago my sis checked into getting one, it wasn't covered by insurance because it would have been considered off label or research. Would be great if we could get the external device. Sign me up.

Years ago, I researched GWS. So much of it fits with me. But I didn't go to war. But I was exposed to lots of toxic chemicals in the air, pesticides and vaccines that I reacted to. Makes one think......

Issie
 

Lesleyb96

New Member
My chiropractor does a type of chiropractic called quantum neurology. It is supposed to stimulate the vagus nerve. First time I had it done I felt comatose and had a million of other symptoms, but it along with some of their other chiropractic techniques have helped me. It's called the Neurolgic relief center in Fayetteville Arkansas. People come from all over, it has really been helpful to folks with Rsd. I know other chiropractors across the United States practice it so may be worth checking out....
 
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Cort

Founder of Health Rising and Phoenix Rising
Staff member
Some people think so....There's a post on it in our Vagus Nerve Resource Section -http://www.healthrising.org/forums/resources/categories/vagus-nerve-and-vagus-nerve-stimulation.179/
My chiropractor does a type of chiropractic called quantum neurology. It is supposed to stimulate the vagus nerve. First time I had it done I felt comatose and had a million of other symptoms, but it along with some of their other chiropractic techniques have helped me. It's called the Neurolgic relief center in Fayetteville Arkansas. People come from all over, it has really been helpful to folks with Rsd. I know other chiropractors across the United States practice it so may be worth checking out....
 
In addition to FM ME/CFS and the terrible migraines I began having soon after getting sick, I've had some problems with Trigeminal Neuralgia a/k/a today as Facial Pain. It makes the trigeminal nerve a very scary thing to mess with - the lightning pain it can emit will bring you to your knees - so I'm wondering if anyone is aware of any studies done with these units on TN patients?
 

cherubim

Well-Known Member
It's ElectroCore - http://www.electrocore.com/

They told me they hope to have approval in the U.S. in a couple of months.
Thank you Cort - that's very interesting. I'm going to read it through. It is probably a micro current they use - if I get it right, with low amps - similar to the body's own. I was looking into those therapies. There is someone who makes a device that is already being marketed in the US - forget the name though - it may come up on a search.
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
Ouch! According to ElectroCore the device has been helpful in cluster headache as well which I believe causes truly horrific pain...Check out their site for more information on that.

http://www.electrocore.com/news-events

You can find a 2014 interview with ElectroCore President here - http://www.medgadget.com/2014/05/vagus-nerve-stimulation-for-the-masses-interview-with-electrocore-ceo-j-p-errico.html

He states;

GammaCore uses the body’s own neural pathways to carry our nVNS therapy, which some refer to as an “electroceutical”, directly to the areas in the brain that release the endogenous chemicals many drug therapies try to modulate. SSRIs, SNRIs, and GABA analogues are some of the largest classes of drugs on the market, and they are designed to alter brain chemistry, and specifically serotonin, GABA, and norepinephrine (also known as noradrenalin). nVNS modulates these same neurotransmitters, but does so without requiring the patient’s liver, kidneys, and other organs to be exposed to foreign chemicals.

Surgically implanted vagus nerve stimulaters have been so effective that.....


In fact, I believe that the only reason that this therapy option hasn’t climbed the continuum of care from a last resort to front line therapy is the cost and requirement for surgery. GammaCore offers the best of both worlds, the same underlying mechanism of action, without the requirement for surgery and the astronomical cost. In terms of putting it in the hands of patients, I can only say that it takes less time to train a patient to use gammaCore than it takes to train a person to use inhaled medications, and with over 500,000 doses administered to date, we haven’t found any device related adverse events.
In addition to FM ME/CFS and the terrible migraines I began having soon after getting sick, I've had some problems with Trigeminal Neuralgia a/k/a today as Facial Pain. It makes the trigeminal nerve a very scary thing to mess with - the lightning pain it can emit will bring you to your knees - so I'm wondering if anyone is aware of any studies done with these units on TN patients?
 

cherubim

Well-Known Member
The device looks just like the electric stimulators they sell on eBay for wrinkles. I wonder if one could use one of them - if they bought a device with the right amps. It might be a way of trying it sooner and cheaper. I read that the 'micro current' is the same as the body. Then there is TENS, IF, and EMS. Of course one would have to use caution.
 

cherubim

Well-Known Member
Ouch! According to ElectroCore the device has been helpful in cluster headache as well which I believe causes truly horrific pain...Check out their site for more information on that.

http://www.electrocore.com/news-events

You can find a 2014 interview with ElectroCore President here - http://www.medgadget.com/2014/05/vagus-nerve-stimulation-for-the-masses-interview-with-electrocore-ceo-j-p-errico.html

He states;




Surgically implanted vagus nerve stimulaters have been so effective that.....
Any nerve pain is bad - I know those 'electric-shocks' and 'knife-stabs'. I've been doing rounds of ALA - maybe you can try that for the Trigeminal Nerve pain. I was going to try the R-ALA but Andrew Cutler states only to use the ALA.
 

Katie

Active Member
It's ElectroCore - http://www.electrocore.com/

They told me they hope to have approval in the U.S. in a couple of months.
I just signed up for their newsletter. I'd love to try it out. The cheaper kind that is.
I have to get back to my own style of vagal stimulation: laying on a rug with lower legs on a chair. I've gotten out of the habit of doing this everyday and I'm not feeling well at all. It's so easy to fall out of doing these small things that do seem to help, even a bit.
 

Issie

Well-Known Member
I just signed up for their newsletter. I'd love to try it out. The cheaper kind that is.
I have to get back to my own style of vagal stimulation: laying on a rug with lower legs on a chair. I've gotten out of the habit of doing this everyday and I'm not feeling well at all. It's so easy to fall out of doing these small things that do seem to help, even a bit.
This looks the same to me. Also has 4 settings......Wonder what strength is needed?
https://www.amazon.com/gp/aw/d/B0108AUG0U/ref=pd_aw_sbs_194_of_10?ie=UTF8&psc=1&refRID=QTYVD0VH7N5PH89P2W8T
 

cherubim

Well-Known Member
Any nerve pain is pretty nasty. I've been doing rounds of ALA - maybe you can try that for the Trigeminal Nerve pain.
That's exactly what I meant. I looked into every therapy I could and was looking into micro current. I have to see if I bookmarked anything good I found. I recall reading the amps have to be very low - to match those of the body. I read something about it helping ATP and energy also. I ended up buying an InTENSity - that has all of the various stimulators - TENS/ IF/ EMS including micro current. It runs off a plug, so you don't have to keep replacing batteries. I looked on the ElectroCore site Cort posted on the device, and I couldn't find anything about the amps in the device. If anyone finds it, can you post it?

I set the unit I have for micro current and have it on my Vagus Nerve to try it out. Micro current is so low, you don't feel it. I don't know how long it would take to see results. I have to buy new pads - these keep falling off.

There have to be multiple ways to stimulate the vagus nerve. Sometimes the cost of a device necessitate finding inexpensive ways to do the same thing.
 
Really interesting. I'm in Europe, does anyone know who supplies it and the name it goes by? I'd be interested in trying it.
I think you are right, GammaCore looks like the best EU device (I've wanted one for two years, not available in all EU countries or the US). I have a Liss and a Cefaly but PoNS and GammaCore look like the devices to watch. There is also NEMOS in the EU, approved for Epilepsy. Liss hasn't helped me (except with POTS, but it is overstimulating to the SNS I find) and Cefaly has helped migraines and possibly a little pain, but I feel intuitively more optimistic about VNS with GammaCore and neuromodulation with the PoNS.
 
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That's exactly what I meant. I looked into every therapy I could and was looking into micro current. I have to see if I bookmarked anything good I found. I recall reading the amps have to be very low - to match those of the body. I read something about it helping ATP and energy also. I ended up buying an InTENSity - that has all of the various stimulators - TENS/ IF/ EMS including micro current. It runs off a plug, so you don't have to keep replacing batteries. I looked on the ElectroCore site Cort posted on the device, and I couldn't find anything about the amps in the device. If anyone finds it, can you post it?

I set the unit I have for micro current and have it on my Vagus Nerve to try it out. Micro current is so low, you don't feel it. I don't know how long it would take to see results. I have to buy new pads - these keep falling off.

There have to be multiple ways to stimulate the vagus nerve. Sometimes the cost of a device necessitate finding inexpensive ways to do the same thing.
I read that VNS should occur on the left side of the neck to avoid any heart issues. This is the reason I have not tried to self hack my vagus nerve with my Tens or Liss. There is one report of death I read from auricular acupuncture to stimulate the VN (might have been the right ear, I can't remember).
 
Surgically implanted vagus nerve stimulaters have been so effective that.....[/QUOTE]
In addition to FM ME/CFS and the terrible migraines I began having soon after getting sick, I've had some problems with Trigeminal Neuralgia a/k/a today as Facial Pain. It makes the trigeminal nerve a very scary thing to mess with - the lightning pain it can emit will bring you to your knees - so I'm wondering if anyone is aware of any studies done with these units on TN patients?
//www.electrocore.com/news-events

I have severe migraines and trigeminal pain and have had good luck with the Cefaly, an FDA approved trigeminal nerve stimulator.
 
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