Navigating the world of migraine treatments? Learn about the gammaCore Sapphire™ device, a non-invasive vagal nerve stimulator designed to treat and prevent migraines. This article explores how the handheld gammaCore device works, its effectiveness, and its potential side effects, providing valuable insights into this innovative migraine therapy.
What is it?
The gammaCore SapphireTM (nVNS) is a handheld device that the patient uses to stimulate the vagus nerve in the neck. The vagus nerve is a communication pathway between the body and the brain and plays an important role in regulating pain.
How is it used?
The device is placed against the side of the neck on the side on which the patient has the most headache. The gammaCore device delivers a 2-minute, gentle electrical stimulation that activates the vagus nerve. It is self-administered, and the patient can adjust 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 recommended that patients stimulate just one side of the neck with 2 two-minute stimulations, starting at pain onset. These sessions can be repeated every 20 minutes if there is 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 waking.
Does it work?
Treating a migraine attack
It is effective for some but not all individuals. In a clinical trial involving 243 people with migraine, half received the real stimulation, and half received a “fake” stimulation (placebo). Results showed that 30.4% of those receiving the real stimulation were pain-free two hours later, compared to 19.7% in the placebo group. Additionally, 40.8% of those receiving the real stimulation had their headache reduced to mild headache or no headache after two hours, compared to 27.6% in the placebo group.
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.
Migraine prevention
In a recent study with 113 participants (which has not been fully published), 45% of those receiving the real stimulation experienced a reduction of 50% or more in the number of migraine days they had per month, compared to 27% in the placebo group.
Are there side effects?
Side effects are minimal. 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 considered a safe and well-tolerated non-drug treatment.
Is gammaCore covered by insurance companies?
gammaCore is not covered by public payers. Coverage by private insurers may vary and should be explored, though it cannot be guaranteed.
Where can I get more information?
gammaCore Sapphire is available in Canada through RSK Medical Inc. For further details about the product and therapy, visit www.gammacoreCanada.com.
References
- 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.
- 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.
- 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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