What is it?

The gammaCore 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.  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.  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 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 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.

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 or 1-905-399-8303.  Please see www.gammacoreCanada.com or 

www.rskmedical.com 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 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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