Noninvasive Neurostimulator Shows Efficacy in Episodic Migraine

LOS ANGELES—Noninvasive vagus nerve stimulation (nVNS) is a rapidly effective, well-tolerated, and practical option for the acute treatment of episodic migraine, according to the results of PRESTO, a multicenter, randomized, sham-controlled, double-blind trial presented at the 70th Annual Meeting of the American Academy of Neurology. “There are multiple options for nVNS in the acute treatment of migraine,” said Cristina Tassorelli, MD, PhD, Professor of Neurology at the University of Pavia and Director of the Headache Science Centre at the Casimiro Mondino National Neurological Institute of Pavia in Italy. “It can be used alone because it is effective, it can be used in combination with drugs because we do not expect any significant interactions, and it is also indicated in patients who have developed medication overuse.”

Cristina Tassorelli, MD, PhD

Neuromodulation for Migraine

The aim of the PRESTO trial was to evaluate the efficacy, safety, and tolerability of gammaCore, an nVNS device, for the acute treatment of migraine. The handheld gammaCore device is already FDA cleared for the acute treatment of pain associated with episodic cluster headache and migraine headache in adults. PRESTO was the trial that supported the FDA clearance of gammaCore for migraine.

Following an observational period of four weeks, patients enrolled in PRESTO were randomized to nVNS or sham stimulation for four weeks or until five attacks were treated. Following this period, patients entered the open-label period for another four weeks or five additional attacks.

Low-intensity current, which induced a tingling sensation on the skin that was similar to the sensation of the active stimulation, was used for the sham stimulation. Patients were instructed to treat their attack early with two two-minute stimulations, one for each side of the neck. At 15 minutes, patients assessed the intensity of their pain. If pain was still present, another set of two stimulations was self-administered. A second assessment of pain occurred at 120 minutes, with the possibility of administering another stimulation. Rescue medication use before 120 minutes was considered to indicate treatment failure.