The prevalence of migraine among women is highest during reproductive years. Expert consensus suggests that devices are relatively safe for use in pregnancy, thus neuromodulation devices are prescribed during pregnancy by headache specialists in clinical practice; however, there are no treatments specifically approved nor investigated for the treatment of migraine in pregnant women, creating a great unmet need.
The remote electrical neuromodulation (REN) device (Nerivio®) is a drug-free, non-invasive, wearable, battery-operated stimulation device, wirelessly controlled by a smartphone application, worn on the upper arm for 45-min treatments. It is Food and Drug Administration–cleared for the acute and/or preventive treatment of migraine with or without aura for episodic and chronic migraine patients aged 12 years and older. While REN is not contraindicated in pregnancy, a precaution mentions that it had not been tested during pregnancy.
A new study, with our own Dr. Audrey Halpern as a coauthor, was recently published in the Headache journal: Safety of remote electrical neuromodulation (REN) for acute migraine treatment in pregnant women: a retrospective controlled survey-study.
The controlled study consisted of a retrospective survey of women with migraine between 18 – 45 years of age who were pregnant during the study period. Participants in the REN (Nerivio) group (59 women) used Nerivio for at least 3 treatments during the study pregnancy period,
While participants in the control group (81 women) treated with various standard care treatments during pregnancy, except for Nerivio.
The study found no statistically significant differences in the following outcomes between pregnant women who used the REN device during pregnancy to treat their migraine, compared to those who did not use the device during this period: gestational age at delivery, baby’s birth weight, miscarriage rate, stillbirth rate, preterm birth rate, birth defects rate, baby meeting developmental milestones 3 months after birth, and rate of emergency room or urgent care visits
Results indicated that the REN device is a safe treatment of migraine during pregnancy, not increasing the risk for adverse pregnancy outcomes, and therefore offering a much-needed non-pharmacological alternative for women with migraine during pregnancy.
A link to this study can be found here: https://headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.14586
By:Alice Wong, NP