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Abstract
Aim: The current study compared the effectiveness of remote electrical neuromodulation (REN) to that of standard-care medications for acute treatments of migraine, using a within-subjects design. Materials&methods:Post-hoc within-subject analysis was performed on data from 78 adult chronic migraine patients who participated in a clinical trial with REN, on four end points: single-treatment pain relief, single-treatment pain freedom, consistency of pain relief and consistency of pain freedom. Results: No statistical differences were found between REN and the tested medications, in any of the effectiveness outcomes: single-treatment pain relief p = 0.056, single-treatment pain freedom p = 0.532, consistency of pain relief p = 0.369, consistency of pain freedom p = 1.00. Conclusion: The results suggest that REN may provide an effective non-pharmacological alternative for standard care abortive medications in individuals impacted by chronic migraine.
Plain language summary
Due to the high frequency of headaches, patients impacted by chronic migraine are struggling with poor quality of life, as well as elevated risk of medication overuse headache (which might cause migraine chronification). Thus, there is a need for non-pharmacological migraine treatments that are both effective and well tolerated.
Remote electrical neuromodulation (REN) is a non-pharmacological abortive migraine treatment, which is US FDA cleared for adults and adolescents with episodic or chronic migraine. The current study compared the effectiveness of REN to that of standard-care medications (i.e., over-the-counter medications and triptans), using data from 78 individuals with chronic migraine who participated in a clinical trial. During the study, each participant treated their attacks with their preferred medication for the first 4 weeks, and then treated their attacks with REN (only) for the following four weeks. The participants rated their pain level prior to each treatment, and 2 h after the beginning of the treatment. The results indicate no statistical difference between the effectiveness of REN and standard care medications and suggest that REN may provide an effective non-pharmacological alternative for standard care abortive medications, for individuals with chronic migraine.
Financial&competing interests disclosure
B Grosberg has received honoraria from Medlink Neurology, from Wiley for book royalities, from Amgen, Lundbeck, Eli Lilly, Theranica, Biohaven Pharmaceuticals, Abbvie, Pfizer and Linpharm for serving in medical advisory. B Grosberg has received research funds directly to institution from Theranica, Eli Lilly and the Migraine Research Foundation. TR Smith has served as an advisor/consultant at Alder/Lundbeck, Amgen, Allergan/Abbvie, Biohaven, Impel Neuropharma, Lilly, Neurolief, Nocira, Teva, Theranica and Vorso/ Nesos in the last 24 months. TR Smith served as a speaker for Amgen, Allergan/Abbvie, Biohaven and Lilly and has provided clinical trial support for Aeon Pharmaceuticals, Alder/Lundbeck, Amgen, Allergan/Abbvie, Biohaven, Boehringer Ingelheim, Charleston Labs, Electrocore, Eliem Pharmaceuticals, Impel Neuropharma, Lilly, Pfizer, Nocira, Novartis, Novo Nordisk, Satsuma, Teva, Theranica, Vorso/Nesos. TR Smith holds stock in United Health Group, and serves as a Board of Directors member (unpaid volunteer work for a non profit organization) in the National Headache Foundation. L Rabany, M Vizel, A Ironi, D Harris, and A Stark-Inbar are employees of Theranica, and receive a salary and stock options. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.
Ethical conduct of research
The clinical trial from which the presented dataset is taken was approved by Western Institutional Review Board ([WIRB]; approval no.: 20192678) and was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all the participants prior to the start of that study.
Data sharing statement
The authors certify that this manuscript reports original data from a clinical trial (NCT04194008). Data will be available for scientific purposes upon request from the corresponding author via email, including raw data and Mc’Nemar tables.