PHILADELPHIA — Combined stimulation of the occipital and trigeminal nerves using a non-invasive stimulation device was found to be effective for the acute treatment of migraine, according to study results presented at the 61st Annual Scientific Meeting of the American Headache Society, held July 11 to 14 in Philadelphia, Pennsylvania.
A total of 55 patients with episodic or chronic migraine were randomly assigned to treat their migraine with a non-invasive occipital and trigeminal nerve stimulation or sham device. Participants were asked to self-administer treatment with the head-worn device soon after migraine onset for a period of one hour. The device was designed to stimulate the 6 branches of the occipital and trigeminal nerves. The study’s primary end point was the change in visual analogue scale score (VAS) one hour after treatment compared with baseline. The VAS was recorded prior to treatment, as well as 1, 2, and 24 hours after treatment.
Pain intensity was reduced in patients using the stimulation vs sham device 1, 2, and 24 hours after treatment (1 hour: group difference, 41%; P =.0002; 2 hours: 33%; P =.03; 24 hours: 36%; P =.02). The percentage of patients indicating a ≥50% pain reduction was greater in patients using the active vs the sham device at 1 hour (67% vs 20%, respectively; P =.001), 2 hours (67% vs 32%, respectively; P =.02), and 24 hours (78% vs 48%, respectively; P =.04) after treatment. A greater percentage of participants using the active vs sham device and who reported severe to moderate pain intensity at baseline reported being pain-free 2 hours after treatment (43% vs 11%, respectively; P =.02). The percentage of patients with severe or moderate baseline pain who reported having mild or no pain at 1 and 2 hours was also greater in participants using the active vs the sham device (1 hour:66.7% vs 26.32%, respectively; P =.01; 2 hours: 76.19% vs 31.58%, respectively; P =.01).
“We hypothesize that the synergistic neuromodulatory effect elicited by concurrent activation of the occipital and trigeminal neural pathways contributes to the superior therapeutic results shown in this study,” noted the study authors.
Schenker E. First non-invasive combined occipital and trigeminal nerve stimulation digital therapeutics system for treatment of migraine: a randomized, sham-controlled, double-blind clinical trial. Presented at: 61st Annual Scientific Meeting of the American Headache Society, July 11-14, 2019, Philadelphia, Pennsylvania. Abstract 681163.