Abstract
Background:
Methods: Participants with migraine with or without aura were eligible for an open-label, single-arm, multiple-attack study. Up to four migraine attacks were treated with two 90-second doses, at 15-minute intervals delivered to the right cervical branch of the vagus nerve within a six-week time period. Subjects were asked to self-treat at moderate or severe pain, or after 20 minutes of mild pain.
Results: Of 30 enrolled patients (25 females, five males, median age 39), two treated no attacks, and one treated aura only, leaving a Full Analysis Set of 27 treating 80 attacks with pain. An adverse event was reported in 13 patients, notably: neck twitching (n= 1), raspy voice (n= 1) and redness at the device site (n= 1). No unanticipated, serious or severe adverse events were reported. The pain-free rate at two hours was four of 19 (21%) for the first treated attack with a moderate or severe headache at baseline. For all moderate or severe attacks at baseline, the pain-free rate was 12/54 (22%).
Conclusions: nVNS may be an effective and well-tolerated acute treatment for migraine in certain patients.
Original language | English (US) |
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Pages (from-to) | 986-993 |
Number of pages | 8 |
Journal | Cephalalgia |
Volume | 34 |
Issue number | 12 |
DOIs | |
State | Published - Oct 27 2014 |
Keywords
- Migraine
- acute treatment
- neuromodulation
- vagus nerve
ASJC Scopus subject areas
- Clinical Neurology