Abstract Details

The CEFALY device is a non-invasive neuromodulation treatment which stimulates the bilateral supraorbital nerves to provide pain relief by targeting the trigeminal nerve.    

To study external trigeminal nerve stimulation (e-TNS) for the acute treatment of migraine.

We conducted a randomized, double blind, sham-controlled, multicenter study at 10 sites in the United States. A total of 538 adults with 2-8 migraine headache days per month were randomized to active or sham stimulation. The primary endpoints for the study were pain freedom at 2 hours and freedom from the MBS at 2 hours. The secondary endpoints were pain relief at 2 hours, absence of all most bothersome migraine-associated symptoms (MBSs) at 2 hours, acute medication use within 24 hours after treatment, sustained pain freedom at 24 hours and sustained pain relief at 24 hours.

Active stimulation was superior to sham stimulation in achieving pain freedom at 2 hours with a therapeutic gain of 7.2% (25.5% versus 18.3%, p=0.043). MBS freedom at 2 hours was also higher in the active stimulation group compared to the sham group (56.4% versus 42.3%, p= 0.001). In regard to secondary outcomes, 69.5% of the active group compared to 55.2% of the sham group experienced pain relief at 2 hours (p=.001). Sustained pain freedom at 24 hours was higher in the active stimulation group compared to the sham group (59% versus 44%, p=0.039) and sustained pain relief at 24 hours was higher in the active group versus the sham group (45.9% versus 34.4% p=0.006). Absence of all MBSs at 2 hours was greater in the active group versus the sham group (42.5% versus 34.1%, p=0.044.

External trigeminal nerve stimulation with the CEFALY device was found to be superior to a sham device in providing pain freedom and freedom from the MBS at 2 hours.