title: Non-invasive vagus nerve stimulation for acute treatment of high-frequency and chronic migraine: an open-label study.
abstract: BACKGROUND
  The treatment of migraine headache is challenging given the lack of a standardized approach to care, unsatisfactory response rates, and medication overuse. Neuromodulation therapy has gained interest as an alternative to pharmacologic therapy for primary headache disorders. This study investigated the effects of non-invasive vagus nerve stimulation (nVNS) in patients with high-frequency episodic migraine (HFEM) and chronic migraine (CM).
  
  
  RESULTS
  In this open-label, single-arm, multicenter study, patients with HFEM or CM self-treated up to 3 consecutive mild or moderate migraine attacks that occurred during a 2-week period by delivering two 120-s doses of nVNS at 3-min intervals to the right cervical branch of the vagus nerve. Of the 50 migraineurs enrolled (CM/HFEM: 36/14), 48 treated 131 attacks. The proportion of patients reporting pain relief, defined as a ≥50% reduction in visual analog scale (VAS) score, was 56.3% at 1 h and 64.6% at 2 h. Of these patients, 35.4% and 39.6% achieved pain-free status (VAS = 0) at 1 and 2 h, respectively. When all attacks (N = 131) were considered, the pain-relief rate was 38.2% at 1 h and 51.1% at 2 h, whereas the pain-free rate was 17.6% at 1 h and 22.9% at 2 h. Treatment with nVNS was safe and well tolerated.
  
  
  CONCLUSIONS
  Non-invasive vagus nerve stimulation may be effective as acute treatment for HFEM or CM and may help to reduce medication overuse and medication-associated adverse events.
authors.affiliation: Headache and Pain Unit, Department of Neurological Motor and Sensorial Sciences, IRCCS San Raffaele Pisana, Via della Pisana 235, 00163, Rome, Italy, piero.barbanti@sanraffaele.it.
authors.forename: Piero
authors.initials: P
authors.lastname: Barbanti
authors.forename: Licia
authors.initials: L
authors.lastname: Grazzi
authors.forename: Gabriella
authors.initials: G
authors.lastname: Egeo
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Padovan
authors.forename: Eric
authors.initials: E
authors.lastname: Liebler
authors.forename: Gennaro
authors.initials: G
authors.lastname: Bussone
mesh_terms: D000328:Adult; D002908:Chronic Disease; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000175:diagnosis* / Q000628:therapy*; D010147:Pain Measurement / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome; D055536:Vagus Nerve Stimulation / Q000379:methods*