Does GammaCore Treat Migraine?

Does GammaCore Treat Migraine?

This is an article by Britt Talley Daniel MD, member of the American Academy of Neurology, the American Headache Society, migraine textbook author and blogger.

 General statement.  Migraine is a genetic condition that is inherited through your DNA.  The genes that transmit migraine have been found and published in the medical literature.  Migraine occurs in 25 % of women and 6 % of men.  For women migraine is their most common chronic medical problem and more prevalent than diabetes, heart disease, or arthritis.  Migraine is the fifth most common cause of disability worldwide in men and women and causes a large amount of clinical and economic burden.

Migraine causes more than a million ER visits every year.  An attack of migraine according to the International Classification of Headache Disorders 3 lasts 4-72 hours and is called episodic migraine if it occurs less than 14 days per month, or chronic migraine if there are more than 15 headache days a month, 8 of which have migraine features.

Emergency Room

Emergency Room

Although many medications are used for treatment of migraine, including the triptans, which are the best and most successful drugs, an estimated 3 million patients are dissatisfied with the current available treatment options.

 Does GammaCore Treat Migraine?  Yes, the FDA  has approved GammaCore nVNS (vagus nerve stimulator) for acute treatment of migraine headache, saying it was “safe and effective.”  Some adults felt relief as quickly as 30 minutes.  Almost half of patients had little to almost no pain within 2 hours.  GammaCore (nVNS) provided relief for more than 50% of attacks for many migraine patients.  The majority of patients who were pain-free at 2 hours remained pain-free for 48 hours.  GammaCore is effective for patients who have failed traditional oral or injectable medications such as triptans.  GammaCore treatment for migraine avoids medication side effects.

 Related Questions

1. What are the side effects of using GammaCore?

GammaCore treated patients did not have any serious treatment related side effects.  Most of the reported side effects were mild, only occurring during the use of the device, and went away after each treatment.  The most common side effects were discomfort and redness at the application site, dizziness, and a tingling feeling where the device was applied in the neck.

GammaCore has been shown to be safe and effective across a range of migraine populations in both the United States and Europe.  Different treatment strategies have been evaluated showing good clinical, safety, and quality of life outcomes at various treatment study times.

2. How does GammaCore (nVNS) work?

GammaCore is a vagus nerve stimulator.  The vagus nerve is one of the largest nerves in the parasympathetic division of the autonomic nervous system.  GammaCore activates the vagus nerve by mild electrical stimulation.  GammaCore therapy is not indicated for children; pregnant women; or patients with active implantable medical devices.

It is also not indicated for patients with carotid atherosclerosis, hypertension, bradycardia/tachycardia, or those with a metallic device.  It shouldn’t be used in patients with a stent, bone plate, or bone screw near the neck. It also shouldn't be used at the same time as the use of a mobile phone or other portable electronic device.

GammaCore Device

GammaCore Device

3. What is the function of the vagus nerve?

The vagus nerve connects the medulla of the brain stem with various target organs in the body.  One of the most well know functions of the vagus nerve is to cause the cells in the lining of the stomach to secrete acid to aid digestion.  The vagus nerve helps regulate pain.  The vagus nerve shuts off inflammation in the body and migraine is an inflammatory medical condition.  Vagus nerve stimulators are also used to treat depression and epilepsy.

The vagus nerve has the longest course of all the cranial nerves, extending from the medulla to the abdomen. Its name is derived from the Latin “vagary” which means “wandering.”  The vagus nerve originates from the medulla of the brainstem to neurons in the stomach, the upper and lower bowel, the bladder, and all the sexual organs.

Vagus Nerve

Vagus Nerve

4. Electrical treatment.  This discussion of previous treatment options for migraine leads into a new electrical stimulator, drug free method of treating migraine—the GammaCore, nVNS, vagus nerve stimulator.

GammaCore, produces a proprietary low-voltage electrical signal comprising a 5 kHz sine wave burst lasting for 1 millisecond (5 sine waves, each lasting 200 microseconds). Such bursts repeated once every 40 milliseconds (25 Hz) generating a 24 V peak voltage and 60 mA peak output current.  

The device is placed vertically below the chin and stimulations are made  until the patient notices contraction of the lower lip on the treated side, indicating location of stimulation over the vagus nerve.

5. Clinical results.  A prospective double-blind, sham-controlled studies of nVNS for the acute treatment of migraine was performed, (PRESTO), and the noninvasive neurostimulation for the prevention of chronic migraine (EVENT) trial were performed.

PRESTO included 243 patients with episodic migraine.  More members receiving nVNS were pain free at 30 minutes (12.7%) than those receiving a sham treatment (4.2%; P = .01). There was also a greater percentage of the nVNS group who were pain free at 60 minutes (21% vs 10%, respectively; P= .02).

"The PRESTO data suggests that GammaCore was rapidly effective, well-tolerated, and practical for the acute treatment of episodic migraine," principal investigator, Cristina Tassorelli, MD, director of the Headache Science Center at the C. Mondino National Neurological Institute, Pavia, Italy, in a press announcement released in 2017.

In the EVENT study, 59 chronic patients with migraine for prevention treatment formed the study population (GammaCore, n=30 vs sham, n=29).  Persistent prophylactic GammaCore use was associated with continued reductions in the number of headache days.

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Britt Talley Daniel MD