Safety and efficacy of remote electrical neuromodulation for the acute treatment of chronic migraine: an open-label study

Abstract

Introduction: Remote electrical neuromodulation (REN) is an acute treatment of migraine. The results from several studies in patients with episodic migraine suggest that REN is an effective and safe acute treatment of migraine. A recent pilot study provided initial support that REN is effective in patients with chronic migraine as well.

Objectives: The current study aimed to validate and provide further evidence for the safety and efficacy of REN in a large sample of patients impacted by chronic migraine.

Methods: In this open-label, single-arm study, patients with chronic migraine treated their headaches with the REN device (Nerivio, Theranica Bio-Electronics Ltd, Israel) for 4 weeks. Participants used an electronic diary to record their symptoms at treatment initiation, 2 hours after treatment, and 24 hours after treatment. The primary end point was the percentage of subjects who achieved pain relief at 2 hours posttreatment. Secondary end points included pain freedom and improvement of associated symptoms and functional disability.

Results: One hundred 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 modified intent-to-treat subjects, respectively (with worst-case sensitivity analysis indicating 54.5% and 19.2%, respectively). Sustained pain relief at 24 hours was observed in 64.4% (29/45) of those who achieved pain relief at 2 hours (with worst-case sensitivity analysis indicating 45.6%). 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: Remote electrical neuromodulation treatments results in the relief of migraine headaches and associated symptoms, thus offering a drug-free acute treatment option for people with chronic migraine.

Trial registration: ClinicalTrials.gov NCT04194008.

Keywords: Conditioned pain modulation; Medication overuse headache; Nerivio; Nonpharmacological; REN.

Conflict of interest statement

B. Grosberg has received book royalties or website access from Wiley and Medlink Neurology; has received research funds directly to his institution from Theranica, electroCore, Dr. Reddy, Migraine Research Foundation, and Neurolief; and is on the Medical Advisory Board of the Migraine Research Foundation, Amgen, Alder, Eli Lilly, Theranica, Neurolief, Lifegraph, Biohaven Pharmaceuticals, and Allergan. C. P. O'Carroll has served as speaker for Lilly, Biohaven, Teva, Amgen, and Allergan. T. Lin, M. Vizel, D. Harris, and A. Ironi are employees of Theranica. J. Schim has been a consultant for Aeon, Allergan, Amgen, Biohaven, electroCore, Impel, Lilly, Lundbeck, Novartis, Promius, Revance, Teva, and Upsher-Smith; has received research funds to his institution from Aeon, Allergan, Amgen, electroCore, Lilly, Lundbeck, Satsuma, Teva, and Zosano; and has served as a speaker for Allergan, Amgen, Biohaven, electroCore, Lilly, Lundbeck, Novartis, Promius, Teva, and Upsher-Smith. The remaining author has no conflicts of interest to declare. This work was supported by Theranica Bio-Electronics LtdTD.Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.

Figures

Figure 1.

Disposition of participants.

Figure 2.

Pain results. The percentage of subjects experiencing pain relief at 2 hours in the test treatment (left), and the percentage of subjects experiencing pain relief at 2 hours in at least half of the treatments (right). The error bars represent 95% confidence intervals. mITT, modified intent to treat.