“The results blew me away. I have never seen an effect as powerful as this.” Dr. Benjamin Natelson

The ‘vagus nerve’ is actually a bundle of different sized nerves. Aptly called the “wanderer”, the tenth and longest cranial nerve enters the brain at the medulla and extends down into the chest cavity and into the abdomen. Eighty percent of the nerve is devoted to relaying information from the body to the brain.

The autonomic nervous system’s Yin to the sympathetic nervous system’s Yang, the vagus nerve regulates the parasympathetic nervous system. It affects everything from the swallowing to digestion to speaking to blood pressure.

Reduced heart rate variability (HRV) findings suggest an underactive vagus nerve may not be keeping the sympathetic nervous system (fight/flight system) under control in chronic fatigue syndrome (ME/CFS) and fibromyalgia (FM). Reduced HRV has been associated with increased pain, cognitive problems and poor sleep in FM and/or ME/CFS. Estrogen, interestingly, appears to accomplish it’s anti-pain functions via the vagus nerve.

Stimulating Health?

Could stimulating the vagus nerve turn down the flight/fight response in fibromyalgia and reduce pain, improve cognition and sleep? Perhaps. Right now VNS usually requires a surgical procedure to implant an electrode in the neck that’s connected to a battery near the collarbone. That’s no small order, but then again treatment resistant fibromyalgia is no laughing matter either.

Most brain stimulation techniques (ECT, rTMS, tDCS) stimulate the brain from the top down but vagus nerve stimulation (VNS) stimulates it from the bottom up. VNS stimulates the cranial nerves in the brain stem that connect directly to the limbic cortex and the monaminergic nuclei. These regions of the brain regulate mood, emotion and autonomic nervous system functioning among others.

VNS upregulates the activity of serotoninergic and noradrenergic neurons in the brain, which generate neurotransmitters (serotonin and noradrenaline). When stimulated in this manner these neurotransmitters are believed to turn on pain inhibiting pathways in the brain.

VNS has been approved in epilepsy and treatment resistant depression. Encouraged by epilepsy and migraine studies suggesting VNS could reduce migraines (common in ME/CFS and FM) and pain, in 2010 a neurologist, Dr. Natelson, decided it was time to give it a try in FM.

The results of his small phase I/II vagus nerve stimulation trial in FM were positive. We didn’t know how positive though, until recently, when Dr. Natelson talked about the study in a two-part radio interview with Dr. Paul Christo.

The Patient

First Dr. Christo introduced a woman, Jean Hasse, with a severe case of fibromyalgia and ME/CFS who’d been in the study. 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 described a fairly touchy surgery done by a neurosurgeon in 2008. The stimulator was turned on about a week after the surgery. Every time it went on (every ten minutes) her neck muscles tightened and she coughed. It took her about six weeks to adjust to the stimulator and the side effects have almost all disappeared.

Her brain fog started disappearing first. Her short term memory problems disappeared. Next the severe radiating joint and nerve pain began to disappear. It happened gradually; by a year later she felt she had been “reborn”.

She still has pain; she’s still taking Lyrica and tramadol but before the surgery she was taking 350mgs. of Lyrica – now she’s on 75. She was 16 tramadol a day and now she’s taking two. She was able to go back to school and get a master’s degree and is now working. She’s also hiking and exercising.

She said for those in pain – not to give up hope.

The Study

Pain Med. 2011 Sep;12(9):1406-13. doi: 10.1111/j.1526-4637.2011.01203.x. Epub 2011 Aug 3. Safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase I/II proof of concept trial. Lange G1, Janal MN, Maniker A, Fitzgibbons J, Fobler M, Cook D, Natelson BH.

Dr. Natelson is no spring chicken. He’s been treating FM and ME/CFS for a long time. He said “The results blew me away. I have never seen an effect as powerful as this.”

By the end of the trial five of the eleven fibromyalgia patients no longer met the criteria for FM. The biggest improvement occurred during the first three months, but improvement, interestingly and encouragingly, tended to increase over time.

The trial was not placebo controlled or randomized but Natelson argued, it was unlikely the improvement were due to a placebo effect for three reasons: patients tended to continue to improve over time, more patients tended to respond over time and placebo effects rarely last a year.

Natelson said about half of the patients in the person trial had similar, life-changing results to Jean’s.

The Catch

The catch is the cost. Vagus nervous stimulation is approved for epilepsy but not for pain. Even though it’s approved for depression insurance companies won’t pay for it. It would probably cost you a cool 30-40K to get one implanted on your own.

Other options are being developed, though. Gammacore’s transcutaneous vagus nerve stimulator worn on the ear is being investigated in Europe. A UK trial is investigating its effectiveness in irritable bowel syndrome. An multicenter European trial for migraine will begin soon. It’s available in the U.S. only for research at the moment.

Nemos has produced an earphone stimulator approved in Europe for epilepsy. It’s conducting a trial in the U.S. for chronic pelvic pain syndrome.

TENS units can be used to stimulate the vagus nerve via the ear. Check out a description of how to prepare them in the Resource section of the Health Rising Forums.

Thus far, transcutaneous vagus nerve stimulators have been effective in tinnitus, in reducing sympathetic nervous system activity, in reducing depression, in improving cognition. It’s a growing field.

Wrapup

Vagus nerve stimulation was stunningly helpful for about half the FM patients in Dr. Natelson’s study. While the patient interviewed by Dr. Christo was not pain free, the VNS allowed her to move from being bedridden to return to work, and hike and exercise, and largely to lead a normal life. She said you’d have to hold me down and tear it out of me to have her give it up.

The fly in the ointment with VNS is availability and cost. The procedure is very expensive and is not covered by insurance. Despite the success of Natelson’s trial, clinicaltrials.gov does not list followup trials.

Cheaper alternatives in the form of transcutaneous vagal nerve stimulators for the ear have been developed and are being tested. Some are available in Europe and some studies are underway in the U.S. Transcutaneous VNS may be not be available for many at the moment but it’s a developing technology and if it’s as effective as the surgical procedure is, it will show up at some point. This is a treatment option to keep an eye on.

Stay tuned…

Contact Dr. Natelson for future studies here.

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