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

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.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
REN’s principle of operation. a Schematic illustration of the principle of operation of REN (modified with permission from Yarnitsky et al. [17]; Headache). The device stimulates C and Aδ noxious sensory fibers of the upper arm above their depolarization threshold yet below the perceived pain threshold. The noxious information reaches the brainstem through the ascending pain pathway (black). This information activates the descending pain inhibitory pathway (green), involving the brainstem pain regulation center (which includes the PAG, RVM, and SRD), which inhibit incoming messages of pain in the trigeminal cervical complex (TCC) that occur during a headache of a migraine attack (red). PAG periaqueductal gray, RVM rostral ventromedial medulla, SRD subnucleus reticularis dorsalis, TCC trigeminal cervical complex. b An image of the device as it is worn on the arm during treatment
Fig. 2
Fig. 2
Disposition chart

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