Temporal Analysis of Remote Electric Neuromodulation for The Prevention of Migraine

Abstract

Aim: To evaluate the onset, magnitude and persistence of efficacy of remote electrical neuromodulation (REN) compared with placebo for the preventive treatment of migraine. Materials & methods: Analysis was conducted on data from a prospective, double-blind, placebo-controlled clinical trial, which assessed the efficacy of REN for the prevention of migraine. The number of monthly migraine days (MMD) per group was calculated in 2-week intervals and compared between the groups. Results: Differences between the active (N = 95) and placebo (N = 84) groups reached significance at 2 weeks: therapeutic gain 0.84 MMD; p = 0.036. 4 weeks gain 1.59 MMD; p = 0.025, 6 weeks gain 2.27 MMD; p < 0.001, 8 weeks gain 2.68 MMD; p < 0.001. Conclusion: REN provides rapid and consistent efficacy in preventive treatment of migraine.

Keywords::

• headache
• migraine
• neuromodulation
• nerivio
• prevention
• prophylaxis
• remote electric neuromodulation
• REN
• treatment
• timing

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.tandfonline.com/doi/suppl/10.2217/pmt-2023-0039

Financial & competeing interests disclosure

The study was funded by Theranica Bio Electronics LTD. AM Blumenfeld: speaker bureau/ advisory board – Abbvie, Allergan, Aeon, Biohaven, Lilly, Impel, Collagium, Amgen, Lundbeck, Theranica, Axsone, Revance. L Rabany, A Stark-Inbar, D Harris and A Ironi are Thranica employees. They receive a salary and hold stock options. AM Harrriott: Science Committee American Academy of Neurology, Board of Directors of the American Headache Society, Board of Directors American Migraine Foundation, Board of Directors Headache Cooperative of New England, Scientific Advisory Board for Theranica, Authorship agreement Abbvie, Received study drug for research from Praxis Inc. RB Halker Singh: Royalties – Oxford University Press, Editorial services – Current Neurology and Neuroscience Reports, Headache Journal. 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 number 20210751) 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

Data will be shared upon request from the authors.

Additional information

Funding

The study was funded by Theranica Bio Electronics LTD. AM Blumenfeld: speaker bureau/ advisory board – Abbvie, Allergan, Aeon, Biohaven, Lilly, Impel, Collagium, Amgen, Lundbeck, Theranica, Axsone, Revance. L Rabany, A Stark-Inbar, D Harris and A Ironi are Thranica employees. They receive a salary and hold stock options. AM Harrriott: Science Committee American Academy of Neurology, Board of Directors of the American Headache Society, Board of Directors American Migraine Foundation, Board of Directors Headache Cooperative of New England, Scientific Advisory Board for Theranica, Authorship agreement Abbvie, Received study drug for research from Praxis Inc. RB Halker Singh: Royalties – Oxford University Press, Editorial services – Current Neurology and Neuroscience Reports, Headache Journal. 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.