9 - Remote electrical neuromodulation for acute treatment of migraine in people with chronic migraine: a pooled analysis of efficacy and safety
Brian Grosberg1, Tamar Lin2, Maya Vizel2, Jack Schim3, Christopher O’Carroll4, Hida Nierenburg5, Paul Wright5
1Hartford Healthcare Headache Center, Hartford, CT, USA. 2Theranica Bio-Electronics, Netanya, Israel. 3The Neurology Center of Southern California, Carlsbad, CA, USA. 4Hoag Neuroscience Institute, Newport Beach, CA, USA. 5Nuvance Health, Poughkeepsie, NY, USA
Purpose Remote electrical neuromodulation (REN) is a novel acute treatment for migraine headaches. The REN device (Nerivio®, Theranica Bio-Electronics LTD., Israel) is FDA-authorized for acute treatment of migraine in adults who do not have chronic migraine. REN has been studied in two studies for acute treatment in patients impacted by chronic migraine. The objective of this pooled analysis was to evaluate the efficacy and safety of Nerivio in this population. Methods Both trials were open-label, single-arm studies in adults aged 18–75 years who met the ICHD-3 criteria for chronic migraine, and included a 4-week treatment phase in which they were asked to treat their headaches with the device. Pain severity levels, associated symptoms and functional disability were recorded at treatment initiation, as well as 2- and 24-hours post-treatment.Efficacy endpoints included pain relief, pain-free, disappearance of associated symptoms, and improvement in function at 2 hours post-treatment. Sustained pain responses at 24 hours and within-subjects consistency were also assessed. Results A total of 168 participants were enrolled in both trials, of which 129 participants were included in the efficacy analyses. Pain relief and pain-freedom at 2 hours were achieved by 56.6% (73/129) and 22.5% (29/129) of participants, respectively. Pain relief response was sustained at 24 hours in 75.4% (43/57) of participants. Nausea, photophobia, and phonophobia disappeared at 2 hours in 57.1% (30/58), 39.8% (39/98), and 45.7% (37/81) of participants, respectively. 53.2% (33/62) of participants experienced improvement in functional ability at 2 hours. Furthermore, 62.1% (80/129) achieved pain relief at 2 hours in at least half of their treated migraine headaches. Two device-related adverse events were reported. Conclusions REN provides clinically meaningful relief of migraine pain and associated symptoms, offering a safe and effective non-pharmacological alternative for acute treatment in patients with chronic migraine.