This study aimed to assess the safety and effectiveness of remote electrical neuromodulation (REN) in people with chronic migraine.

REN (Nerivio^®, Theranica Bio-Electronics LTD., Israel) is an acute treatment for migraine. Results from several studies in patients with episodic migraine suggest that REN is an effective and safe acute treatment of migraine. In addition, a recent pilot study provided initial support that REN is effective in patients with chronic migraine, but additional data is needed to establish the effectiveness of REN in this population.

In this open-label, single-arm study, patients with chronic migraine treated their headaches with the device for 4 weeks following a 4-week run-in phase. Pain levels, associated symptoms and functional disability were recorded at treatment initiation, 2 hours after the treatment and 24 hours after the treatment.

One hundred and twenty-six subjects were enrolled into the study, of which 91 subjects had an evaluable treatment with REN. Pain relief and pain disappearance at 2 hours were achieved by 59.3% (54/91) and 20.9% (19/91) of subjects, respectively. Sustained pain relief at 24 hours was observed in 73.3% (33/45) of subjects. The findings of the study show that REN has a favorable effect on nausea, photophobia, and phonophobia, and improves functional ability. One device-related adverse event was reported.

REN treatments results in the relief of migraine headaches and associated symptoms, thus, offering a drug-free acute treatment option for people with chronic migraine.