Robert A. Bonakdar, MD FAAFP FACN
Director of Pain Management
Scripps Center for Integrative Medicine
Scripps Center for Integrative Medicine
San Diego, California
Megan Sweeney, MA, MPH
Doctoral Student
Loma Linda University, School of Behavioral Health
Redondo Beach, California
A 34 y.o. G1P0 female at 28-weeks gestation was referred by her primary care physician for worsening migraine status. She described her first migraine at the age of 15. Long-term patterns included 4-6 days of migraine without aura typically associated with her menstrual cycle. She typically treated these acutely with acetaminophen and NSAIDS. She had previously attempted sumatriptan but discontinued due to intolerance.
The patient experienced her first pregnancy-related migraine at week 16. Migraine episodes increased and by 22 weeks, she was experiencing 1-2 severe migraines (9/10 severity) per week that lasted 3-4 days each with light sensitivity and mental fatigue. The patient tried increasing hydration, acetaminophen, topical peppermint and acupuncture without notable reduction in migraine symptoms. Labs (e.g., Vitamin D and B12) and vitals were within normal limits. Medications and supplements included acetaminophen, a prenatal vitamin, vitamin D and omega-3 supplement as well as occasional ginger and chamomile tea.
Methods:
During the evaluation, the patient completed The Migraine Disability Assessment (MIDAS), which showed a total score of 47 indicating severe disability:
Over the last 90 days:
Days of missed work/school: 5
Days of reduced productivity at work/school: 10
Days unable to do household work: 10
Days reduced productivity with household work:10
Days of missed family, social or leisure activities: 12
Days with a headache? 20
Average pain level with headaches? 9/10
After review of potential treatment options, the patient started the Nerivio Remote Electrical Neuromodulation (REN) device. The patient received instructions on the REN device, which is worn on the upper arm for 45 minute-treatments. These signals trigger an endogenous analgesic mechanism known as conditioned pain modulation. The device was cleared as the first first smartphone-controlled acute migraine-relief wearable device in 2019 and is now indicated in prevention and treatment of migraine in adults and children age 8 and above and has undergone safety monitoring for pregnant individuals with episodic migraine.
Prescription for Use: Due to the nearly daily frequency of patient’s migraine, the patient was instructed to use the device both as a scheduled preventative treatment every other day as well as acutely for any migraine attacks.
Results:
After 2 uses of the device, patient noted an improvement in the severity and duration of her migraine episodes. She also began using the device acutely and was able to abort or significantly reduce the progression of her migraine episodes. She did not require acetaminophen or other agents and was able to rely exclusively on the device for migraine management during pregnancy. Of note, during this time, patient did not initiate any new interventions.
In a follow up of her MIDAS questionnaire after one month of use, patient scored a 5 (minimal to no interference) and noted 2 headaches over the last month with an average severity of 2/10. The patient also noted less associated symptoms including light sensitivity and cognitive symptoms. Patient also offered a comment during a follow up interview: "Once I was pregnant, my options got even smaller. I was so desperate to find relief. Since I started using Nerivio, I haven't needed medications in over a month. It's brought me so much peace and even a relaxing sensation when I wear it. I can still move, stay active, and feel like myself again. I know pregnancy can make women nervous to try something new, but this was worth it ... knowing I have some control over the pain."
Conclusions/Implications for future research and/or clinical care:
Conclusions: This case study provides patient-centered details regarding the efficacy of REN for the management of migraine and associated symptoms during pregnancy. As migraine during pregnancy is common and this therapy has been previously evaluated for safety, clinicians should consider its use as a first-line therapy. The device appeared to have increasing benefit based on frequency of use, which should be considered especially in high burden migraine scenarios. The use of REN in this scenario would benefit from a randomized trial to confirm safety and benefit for migraine and to provide additional controlled data for clinicians to confidentially consider recommending for migraine treatment during pregnancy.
References:
Peretz A, Stark-Inbar A, Harris D, Tamir S, Shmuely S, Ironi A, Halpern A, Chuang L, Riggins N. Safety of remote electrical neuromodulation for acute migraine treatment in pregnant women: A retrospective controlled survey-study. Headache. 2023 Jul-Aug;63(7):968-970.
Synowiec A, Stark-Inbar A, Weinstein M, Ironi A, Mauskop A. One-Year Consistent Safety, Utilization, and Efficacy Assessment of Remote Electrical Neuromodulation (REN) for Migraine Treatment. Adv Ther. 2024 Jan;41(1):170-181.
Smirnoff L, Bravo M, Hyppolite T. Neuromodulation for Headache Management in Pregnancy. Curr Pain Headache Rep. 2025 Jan 7;29(1):14. doi: 10.1007/s11916-024-01344-1.