The vagus nerve stimulator known as gammaCore, which creators said was the first such noninvasive hand-held treatment, provided relief for the pain linked to migraines and episodic cluster headaches in adults, according to findings presented at the American Academy of Neurology Annual Meeting.
“GammaCore is used by applying a conductive gel to the stimulation surfaces of the device and placing it on the neck,” Peter Staats, MD, MBA, chief medical officer of electroCore, manufacturer of gammaCore, told Healio Family Medicine.
“The patient then delivers a gentle, 2-minute stimulation, which activates the vagus nerve... It is the first neuromodulation applied at the neck for the acute treatment of pain associated with migraines in adults and episodic cluster headaches and provides patients with an effective option to treat as needed, without potential side effects associated with commonly prescribed drugs,” he said.
GammaCore has FDA clearance based on the PRESTO clinical trial. This multicenter, double-blind, randomized, sham-controlled trial evaluated the efficacy, safety and tolerability of the treatment in 243 patients with episodic migraine.
According to the company, gammaCore performed better than placebo for the first migraine attack at 30 minutes (12.7% vs. 4.2%; P = .012) and 60 minutes (21% vs. 10%; P = .023), and barely missed significance at 120 minutes (30.4% vs. 19.7%; P =.067).
In addition, post hoc repeated-measures analyses determined gammaCore was better than placebo through 120 minutes (OR = 2.3; 95% CI, 1.2-4.4) and in secondary endpoints of pain relief at 120 minutes (40.8% vs. 27.6%; P = .03) and mean percent pain reduction (34.8% vs. 5.4%; P =.004), which is based on post hoc analyses.
The therapy may have other potential uses, Staats said in the interview.
“ElectroCore is conducting clinical trials and will be working to secure regulatory release for additional future indications. We have identified an extensive number of conditions that may respond to noninvasive vagus nerve stimulator, including migraine prevention as well as treatment for posttraumatic headache and acute migraines in adolescents,” he said. “We are also in the early stages of investigating gammaCore in patients with Sjögren’s disease and rheumatoid arthritis.” – by Janel Miller
Staats is an employee of electroCore.