Noninvasive vagus nerve stimulation (nVNS) provided participants with episodic migraine pain reduction or complete pain relief in as little as 30 minutes and for as long as 120 minutes after onset of attack, according to study results published in Neurology.
Researchers of the Prospective Study of nVNS for the Acute Treatment of Migraine (PRESTO; NCT02378844)—a randomized, double-blind, sham-controlled study—evaluated the efficacy, safety, and tolerability of noninvasive vagus nerve stimulation when used as a pain control option for patients with episodic migraine with or without aura. Participants were randomly assigned to either the sham control arm or the noninvasive vagus nerve stimulation treatment arm.
All patients self-administered the stimulations, with the treatment arm using low-voltage electrical signals with a 5-kHz sine wave burst and 24-V peak voltage and the sham arm receiving a low-frequency biphasic signal. Patients were asked to record treatments and results in an electronic diary. This study included a 4-week, double-blind period followed by a 4-week, open-label period.
Of the 120 patients in the treatment arm, 79.2% were female and the average age was 38.8±11 years old. Of the 123 patients in the sham arm, 74% were female and the average age was 39.6±11.8 years old. After the first treated attack, more patients in the treatment arm were pain-free at 30 and 60 minutes when compared with the sham arm (12.7% vs 4.2%, P =.012; 21% vs 10%, P =.023, respectively), and repeated measures indicated that the treatment arm was superior at 30, 60, and 120 minutes (odds ratio 2.3; 95% CI, 1.2–4.4; P =.012).
After the first treated attack, more patients in the treatment arm experienced some pain relief at 120 minutes when compared with the sham arm (40.8% vs 27.6%; P =.03), and the mean percentage pain score reductions were significantly more for the treatment arm at 60 minutes and 120 minutes when compared with the sham arm (−25.4% vs −7.7%, P =.033; −34.8% vs −5.4%, P =.004, respectively).
More patients reported not vomiting 120 minutes after the first treated attack in the treatment arm compared with the sham arm (75% vs 37.5%; P =.315). Bang Blinding Index estimates indicated that the patients were successfully blinded to their protocol. Responses for the nVNS continued into the open-label period, with 26.8% being free from pain and 41.8% finding some pain relief.
Discomfort at the application site and nasopharyngitis were the most common adverse events reported in the treatment arm, and application site erythema and pain, dizziness, flu-like symptoms, and nasopharyngitis were the most common adverse events reported in the sham arm. Overall, 96% reported the device was somewhat or very easy to use, and 60.2% of the treatment arm would recommend the device to family or friends.
The limitations of this study include the fact that the stimulation in the sham arm, although not as powerful as the treatment arm, could have elicited some physiologically active response or a psychobiological placebo effect.
The researchers concluded that the efficacy, safety, and tolerability of nVNS for migraine pain control make this therapeutic approach a clinically relevant treatment option.
This study was supported by electroCore INC, the company that owns gammaCore™, the noninvasive vagus nerve stimulator. Please refer to original reference for a complete list of authors’ disclosures.
Tassorelli C, Grazzi L, de Tommaso M, et al. Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study. 2018;91(4):e364-e373.