A 1-hour treatment with external trigeminal nerve stimulation (e-TNS) was found to alleviate pain in individuals with migraine without aura, according to a study published in Cephalalgia.
In the first double-blind randomized sham-controlled trial evaluating the safety and efficacy of e-TNS for the acute treatment of migraine with and without aura, 99 patients were treated with verum (n=47) or sham (n=52) e-TNS for 1 hour. The trial named ACME (Acute treatment of Migraine with External trigeminal nerve stimulation; ClinicalTrials.gov identifier: NCT02590939), was conducted at 3 headache centers in the United States between February 2016 and March 2017. Patients were asked to rate pain intensity using an 11-point visual analogue scale at baseline, immediately after the 1-hour acute treatment phase, and at 2 hours and 24 hours post-treatment. Neurostimulation was administered via the e-TNS CEFALY device.
Mean change in pain score at 1 hour compared with baseline was decreased in patients treated with both verum and sham stimulation (P <.0001), but participants in the verum vs sham group reported greater levels of pain reduction (-59% vs -30%, respectively). The treatment efficacy remained significant in a post hoc analysis (P <.0001). Mean pain score reduction was higher in the verum vs sham group at 2 hours (-50% vs -32%, respectively; P =.026) and at 24 hours (-57% vs -40%, respectively; P =.037) compared with baseline levels.
The researchers acknowledge small sample size and clinical setting for the trial as potential limitations.
”e-TNS is safe and well tolerated, offering migraine patients a non-invasive, acute treatment option that lacks the systemic side effects associated with conventional migraine medications,” concluded the study authors.
This study was supported by CEFALY Technology. Please refer to reference for a complete list of authors’ disclosures.
Chou DE, Shnayderman Yugrakh M, Winegarner D, Rowe V, Kuruvilla D, Schoenen J. Acute migraine therapy with external trigeminal neurostimulation (ACME): A randomized controlled trial [published online November 17, 2018]. Cephalalgia. doi:10.1177/0333102418811573