On January 29, 2018, the FDA approved gammaCORE, a hand-held, non-invasive, vagus nerve stimulator (nVNS) for the treatment of migraine pain in adults. The device was first approved in April 2017 for the treatment of episodic cluster headache pain in adults.
Results from the PRESTO study, a randomized, multicenter prospective study of nVNS for the acute treatment of migraine, were instrumental in the expanded indication. A total of 243 people with episodic migraine were included in the study; 123 received nVNS and 120 received sham (placebo) treatment. A significantly greater proportion of people receiving nVNS were pain free at 30 minutes (12.7%) versus those receiving sham treatment (4.2%; P=0.01) and at 60 minutes (21% versus 10% respectively; P=0.02). Between-group differences at 120 minutes missed statistical significance, (30.4% nVNS vs 19.7% sham; P=0.07), but a post-hoc repeated-measures test was performed to examine inconsistency between the 120-minute findings and the 30- and 60-minute findings and did show significance.
The manufacturer, electroCORE LLC, reports that the device will be commercially available for the treatment of migraine pain in adults in the second quarter of 2018. It’s important to note that the safety and efficacy of gammaCORE have not been been confirmed for the acute treatment of chronic cluster headache or for preventative treatment of chronic or episodic cluster headache or migraine. The device also is not indicated for use in children, pregnant women, people with active implantable medical devices, people with conditions like carotid atherosclerosis, hypertension, or bradycardia/tachycardia, or people with a metallic device near the neck. The gammaCORE device also should not be used at the same time that a person is using his or her mobile phone or other portable electronic device.