The treatment device from Theranica also demonstrated a positive impact on patients who experienced menstrual cramps or pelvic pain.
Data from an observational peer-reviewed study (NCT04600388) suggests that treatment with Theranica’s remote electrical neuromodulation (REN) Nerivio migraine device is safe and effective to treat women who experience menstrually related or pure menstrual migraine.1,2
Nerivio, the first FDA-cleared smartphone-controlled prescription wearable device for the acute treatment of migraine, was evaluated for at least 4 treatment sessions in 91 women aged 18 to 55 years with menstrual migraine. Of that cohort, 74.7% (n = 68) reported that the treatment was at least moderately effective (moderately effective, 37.4%; very effective, 26.4%; extremely effective, 11%) in treating menstrual migraine.
"Menstrual migraine is a significant challenge for traditional migraine treatments,” primary investigator Hida Nierenburg, MD, board-certified neurologist and headache specialist, Nuvance Health, said in a statement.1 “This study provides hope for the many women whose migraine headaches are associated with menstruation. The remote electrical neuromodulation therapy provides patients with a non-pharmaceutical option that is safe and effective. This can be especially important option for women who are taking other medications and may be at risk for drug-drug interactions.”
In total, 45.1% (n = 41) of participants reported satisfaction from REN (slightly satisfied, 33%; extremely satisfied, 12.1%), while 34.1% (n = 31) were neutral, and 20.9% (n= 19) were not satisfied (slightly dissatisfied, 16.5%; not at all satisfied, 4.4%).
A subpopulation of patients (n = 75) indicated they experience menstrual cramps. Out of these 75, 38.7% (n = 29) reported that REN was at least moderately effective (moderately effective, 28%; very effective, 8%; extremely effective, 2.7%) in treating the cramps. The treatment was reported not effective for cramps in 61.3% (n = 46) of the participant population (slightly effective, 29.3%; not effective, 32.2%).
Pelvic pain experienced during menstruation was documented in 41.8% patients (n = 38). Of this cohort, 36.8% (n = 14) reported that REN was at least moderately effective for the pelvic pain (moderately effective, 28.9%; very effective, 2.6%; extremely effective, 5.3%). On the other hand, 63.2% (24 of 38) reported the treatment was not effective in reducing pelvic pain (slightly effective, 28.9%; not effective, 34.2%).
"Migraine is much more prevalent among women than men, especially during their menstruation years,” Liron Rabany, PhD, chief scientist, Theranica, said in a statement.1 “Demonstrating these positive study results specifically for menstrual migraine is therefore highly important in solidifying the key role that remote electrical neuromodulation can have in the therapy toolkit of every woman with migraine.”
All participants reported that the treatment was at least moderately tolerable (moderately tolerable, 8.8%; very tolerable, 20.9%; extremely tolerable, 70.3%). Mild short-term adverse effects were reported in 13.2% of participants (n = 12). They included sore arm for several days after treatment (n = 1), bruise on the arm (n = 1), nausea (n = 2), dizziness (n = 1), drowsiness (n = 1), muscle twitching (n = 3), numbness in the arm during treatment (n = 2), and tingling in the arm and hand (n = 1).
The use of rescue medications following REN treatments was observed in 69 participants during the studied period. Of those, 40.9% (n = 27) had never taken any medications within 2 hours from the treatment onset in any of the REN treatments they have done. Additionally, 66.7% (n = 46) were medication free in at least 75% of the treatments, and 92.8% (n = 64) were medication free in at least 50% of their REN treatments.
Nerivio REN originally gained approval to acutely treat episodic or chronic migraine in patients aged 18 years or older in October 2020, but later received expanded indication to treat adolescents aged 12 years and older in January 2021.