What is it? The gammaCore SapphireTM (nVNS)  is a hand-held device that the patient uses to stimulate the vagus nerve in the neck.  The vagus nerve is an important highway of communication between the body and the brain and plays an important role in regulating pain.

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. The gammaCore delivers a 2-minute, gentle electrical stimulation that activates the vagus nerve. gammaCore is self-administered and the patient can increase or decrease the stimulation intensity to a comfortable level.

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.

Treating a migraine attack

In the PRESTO study which evaluated using gammaCore to treat migraine attacks, 48% of patients had little to no migraine pain within 2 hours after first use for more than 50% of all treated headaches. (Tassorelli C, Grazzi L, de Tommaso M, et al. Noninvasive vagus nerve stimulation as acute therapy for migraine: the randomized PRESTO study. Neurology. 2018;91(4):364-e373.)

Are there side-effects?

People experience few side-effects.  Reported side effects, such as application site discomfort/irritation (rash), are often mild and typically resolve shortly after the stimulation is complete. Some people may experience some dizziness. Overall gammaCore is a safe and well-tolerated non-drug treatment.

How much does gammaCore 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 gammaCore covered by insurance companies?

gammaCore is not covered by public payers (May 2021). Coverage by private payers needs to be explored.

Where can I get more information?

gammaCore Sapphire is now available through a Canadian distributor named RSK Medical Inc. (Markham, ON).  They can be reached via www.generalinquiry@rskmedical.com or 1-905-399-8303.  Please see www.gammacoreCanada.com or www.rskmedical.com for further product and therapy related details.

July 7, 2021