Remote Electrical Neuromodulation for the Acute Treatment of Chronic Migraine (2007)

Objective: This study aimed to assess the safety and effectiveness of remote electrical neuromodulation (REN) in people with chronic migraine. Background: 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. Design/Methods: 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. Results: 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. Conclusions: 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. Disclosure: Dr. Grosberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Dr. Grosberg has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck . Dr. Grosberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theranica. Dr. Grosberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan. Dr. Grosberg has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen. Dr. Grosberg has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Theranica . Dr. Grosberg has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biohaven. Dr. Grosberg has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Allergan. Dr. Grosberg has received stock or an ownership interest from Theranica. The institution of Dr. Grosberg has received research support from Theranica. The institution of Dr. Grosberg has received research support from Electrocore. The institution of Dr. Grosberg has received research support from Dr. Reddy. The institution of Dr. Grosberg has received research support from Migraine Research Foundation. Dr. Grosberg has received publishing royalties from a publication relating to health care. Tamar Lin has received personal compensation for serving as an employee of Theranica Bio-Electronics. Maya Vizel has received personal compensation for serving as an employee of Theranica Bio-Electronics. Dr. Schim has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Aeon, Allergan, Amgen, Biohaven, electroCore, Impel, Lilly, Lundbeck, Novartis, Promius, Revance, Teva, Upsher-Smith. Dr. Schim has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Allergan, Amgen, Biohaven, electroCore, Lilly, Lundbeck, Novartis, Promius, Teva, Theranica, Upsher-Smith.