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[/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:
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
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[/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
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
“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.
- See the "Being Reborn" blog in Health Rising's Vagus Nerve Stimulation Resource section
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]
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
- Mount Sinai Beth Israel Hospital
- Pain and Fatigue Study Center - Beth Israel Medical Center
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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