One-hour treatment with external trigeminal nerve stimulation resulted in significant headache pain relief compared to sham stimulation and was well tolerated, according to a recent double-blind, randomized, sham-controlled study conducted across 3 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 for 1 hour. Pain intensity was scored using a visual analog scale. Researchers found:
- One hundred and six patients were randomized and included in the intention-to-treat analysis (verum: n=52; sham: n=54).
- The primary outcome measure was significantly more reduced in the verum group than in the sham group: −3.46 ± 2.32 vs −1.78 ± 1.89, or −59% vs −30%.
- With regards to migraine subgroups, there was a significant difference in pain reduction between verum and sham for “migraine without aura” attacks.
- For “migraine with aura” attacks, pain reduction was numerically greater for verum vs sham, but did not reach significance: mean visual analog scale reduction at 1 hour was −4.3 ± 1.8 for the verum group vs −2.6 ± 1.9 for the sham group.
Chou DE, Yugrakh MS, Winegarner D, Rowe V, Kuruvilla D, Schoenen. Acute migraine therapy with external trigeminal neurostimulation (ACME): A randomized controlled trial. [Published online ahead of print November 17, 2018]. Cephalalgia. doi:10.1177%2F0333102418811573.