Remote Electrical Neuromodulation (REN) for the Acute Treatment of Menstrual Migraine: a Retrospective Survey Study of Effectiveness and Tolerability

Hida Nierenburg; Liron Rabany; Tamar Lin; Roni Sharon; Dagan Harris; Alon Ironi; Paul Wright; Linus Chuang

doi:10.1007/s40122-021-00276-7

Remote Electrical Neuromodulation (REN) for the Acute Treatment of Menstrual Migraine: a Retrospective Survey Study of Effectiveness and Tolerability

Pain Ther. 2021 Dec;10(2):1245-1253. doi: 10.1007/s40122-021-00276-7. Epub 2021 Jun 17.

Authors

Hida Nierenburg¹, Liron Rabany², Tamar Lin², Roni Sharon³, Dagan Harris², Alon Ironi², Paul Wright⁴, Linus Chuang⁵

Affiliations

¹ Division of Neurology, Nuvance Health, Poughkeepsie, NY, USA. hida.nierenburg@nuvancehealth.org.
² Theranica Bio-Electronics, Netanya, Israel.
³ Headache and Facial Pain, Sheba Medical Center, Ramat Gan, Israel.
⁴ Division of Neurology, Nuvance Health, Poughkeepsie, NY, USA.
⁵ Department of Obstetrics, Gynecology and Reproductive Biology, Danbury Hospital, Nuvance Health, 24 Hospital Avenue, Danbury, CT, 06810, USA.

Abstract

Introduction: Migraine is one of the most prevalent neurological disorders worldwide, and estimations are that 60% of women who suffer from migraines experience attacks that are associated with menstruation. Menstrual migraines are typically more debilitating and less responsive to pharmacological treatment. Remote electrical neuromodulation (REN) is a non-pharmacological abortive treatment of migraine headache. The current study evaluated the self-reported effectiveness and tolerability of REN for the acute treatment of menstrual migraine, via a retrospective structured survey that was sent to adult female REN users.

Methods: Women aged 18-55 years who experience menstrually related or pure menstrual migraine and have completed at least four REN treatments, participated in this retrospective, observational survey study. Participants completed a short online survey assessing effectiveness, satisfaction, and safety outcomes.

Results: Ninety-one participants qualified for the analysis, out of which 74.7% (68/91) reported that the treatment was at least moderately effective (moderately effective 37.4%, very effective 26.4%, extremely effective 11.0%). Additionally, 45.1% (41/91) reported satisfaction from REN (slightly satisfied 33%, extremely satisfied 12.1%), while 34.1% were neutral and 20.9% (19/91) were not satisfied. Lastly, 100% of the participants reported that the treatment is at least moderately tolerable (moderately tolerable 8.8%, very tolerable 20.9%, extremely tolerable 70.3%), and 13.2% (12/91) of respondents reported mild short-term side effects.

Conclusions: Nearly 75% reported that the treatment was at least moderately effective, 45% reported satisfaction, and 100% of the participants reported that the treatment is at least moderately tolerable. Thirteen percent reported mild short-term side effects. REN was thus reported as effective for menstrual migraine by most participants and was very well tolerated. Therefore, REN may provide a safe, non-pharmacological alternative for the acute treatment of menstrual migraine. CLINICALTRIAL.

Gov registration number: NCT04600388.

Keywords: Analgesia; Headache; Menstrual pain; Menstruation; Migraine; Nerivio; REN; Remote electric neuromodulation; Treatment; Women’s health.

Associated data

ClinicalTrials.gov/NCT04600388