Acute migraine therapy with external trigeminal neurostimulation (ACME): A randomized controlled trial.

ABSTRACT:

Objective

To assess the safety and efficacy of external trigeminal nerve stimulation for acute pain relief during migraine attacks with or without aura via a sham-controlled trial.

Methods

This was a double-blind, randomized, sham-controlled study conducted across three headache centers in the United States. Adult patients who were experiencing an acute migraine attack with or without aura were recruited on site and randomly assigned 1:1 to receive either verum or sham external trigeminal nerve stimulation treatment (CEFALY Technology) for 1 hour. Pain intensity was scored using a visual analogue scale (0 = no pain to 10 = maximum pain). The primary outcome measure was the mean change in pain intensity at 1 hour compared to baseline.

Results

A total of 109 participant

SUBMITTER: Chou DE 

PROVIDER: S-EPMC6348457 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature