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GammaCore Sapphire Device for Non-Invasive Vagal Nerve Stimulation and Migraine

What is it?

The GammaCore

<span style="font-weight: 400;">gammaCore is the first non-invasive, hand-held medical device applied at the neck that acutely treats the pain associated with episodic cluster headache in adult patients through the transmission of a mild electrical stimulation to the vagus nerve through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with standard of care.</span><i><span style="font-weight: 400;">Reference: gammaCore®,</span></i> <i><span style="font-weight: 400;">https://www.electrocore.com/news/gammacore-the-first-non-invasive-vagus-nerve-stimulator-applied-at-the-neck-now-available-for-adult-patients-in-the-u-s/</span></i><i><span style="font-weight: 400;">, </span></i><span style="font-weight: 400;">july 2</span><span style="font-weight: 400;">nd</span><span style="font-weight: 400;">,2019</span>
" >gammaCore [1] Sapphire device is a hand-held device that the patient uses to stimulate the vagus nerve in the neck. 

How is it used? 

The device is held against the side of the neck on the side on which the patient has the most headache, and electrical current stimulates the vagus nerve through the skin.

What can it be used for?

It can be used to treat individual migraine attacks [2].  For this, it is now recommended that patients stimulate just one side of the neck with 2 two-minute stimulations, starting at pain onset.  These can be repeated in 20 minutes if there has been no improvement.

It can also be used for migraine prevention [3].  For this, it is recommended to use 2 two-minute stimulations on one side only and do this three times a day.  Stimulation should always be on the same side, and the first stimulation should be done within one hour of awakening.

Does it work?

Treating a Migraine

<span style="font-weight: 400;">A migraine is a powerful headache that often happens with nausea, vomiting, and sensitivity to light. Migraines can last from 4 hours to 3 days, and sometimes longer.Most people start having migraine headaches between ages 10 and 40. But many women find that their migraines improve or disappear after age 50.</span><i><span style="font-weight: 400;">Référence : webmd.com, </span></i><i><span style="font-weight: 400;">https://www.webmd.com/migraines-headaches/migraines-headaches-migraines#1</span></i><i><span style="font-weight: 400;">  consulted on july 4</span></i><i><span style="font-weight: 400;">th</span></i><i><span style="font-weight: 400;">,2019.</span></i>
" >migraine [4] attack

It works for some people but not everybody.  In a clinical research trial with 243 people with migraine, half got the real stimulation, and half received a “fake” stimulation (placebo).  30.4 % of people who received the real stimulation were pain-free two hours later, while only 19.7 % of people who got the fake stimulation were pain free.

40.8 % of people who got the real stimulation had their headaches reduced to mild headache or no headache by two hours, while 27.6 % of those who received the fake stimulation were reduced to mild or no headache.

Migraine

<span style="font-weight: 400;">A migraine is a powerful headache that often happens with nausea, vomiting, and sensitivity to light. Migraines can last from 4 hours to 3 days, and sometimes longer.Most people start having migraine headaches between ages 10 and 40. But many women find that their migraines improve or disappear after age 50.</span><i><span style="font-weight: 400;">Référence : webmd.com, </span></i><i><span style="font-weight: 400;">https://www.webmd.com/migraines-headaches/migraines-headaches-migraines#1</span></i><i><span style="font-weight: 400;">  consulted on july 4</span></i><i><span style="font-weight: 400;">th</span></i><i><span style="font-weight: 400;">,2019.</span></i>
" >Migraine [4] prevention

In the most recent study, with 113 people, which has not been fully published yet, 45% of patients who received the real stimulation had a reduction of 50% or more in the number of migraine days they had per month.  This compared to 27% of people who received the “fake” stimulation.

Are there side-effects?

People experience few side-effects.  Discomfort and rash at the place where the stimulator is applied has been reported, and Dizziness

<span style="font-weight: 400;">Dizziness is a term used to describe a range of sensations, such as feeling faint, woozy, weak or unsteady. Dizziness that creates the false sense that you or your surroundings are spinning or moving is called vertigo.</span><i><span style="font-weight: 400;">Reference : By Mayo Clinic Staff,</span></i> <i><span style="font-weight: 400;">https://www.mayoclinic.org/diseases-conditions/dizziness/symptoms-causes/syc-20371787</span></i><i><span style="font-weight: 400;"> , </span></i><span style="font-weight: 400;">july 1</span><span style="font-weight: 400;">st</span><span style="font-weight: 400;">,2019</span>
" >dizziness [5].

How much does Gamma Core cost?

The cost of the 31 day Starter Kit is $655. CDN (up to 30 stimulations of 2 minutes per day).  The 93 day starter kit is $1,365 CDN.

Is Gamma Core covered by insurance companies?

Gamma Core is not covered by public payers (May 2021). Coverage by private payers needs to be explored, but cannot be guaranteed.

Where can I get more information?

 The Sapphire system is now available through a Canadian distributor named RSK Medical Inc. (Markham, ON).  They can be reached via generalinquiry@rskmedical.com [6] or 1-905-399-8303.  Please see www.gammacoreCanada.com [7] or 

www.rskmedical.com [8] for further product and therapy related details.

REFERENCES

1.         Diener HC, Goadsby PJ, Ashina M, Al-Karagholi MA, Sinclair A, Mitsikostas D, et al. Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment [9] of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial. Cephalalgia. 2019;39(12):1475-87.

2.         Tassorelli C, Grazzi L, de Tommaso M, Pierangeli G, Martelletti P, Rainero I, et al. Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study. Neurology. 2018;91(4):e364-e73.

3.         Johnson RL, Wilson CG. A review of vagus nerve stimulation as a therapeutic intervention. J Inflamm Res. 2018;11:203-13.

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