Real-World Study Demonstrates Efficacy and Safety of Remote Electrical Neuromodulation for Adolescents with Migraine

According to an analysis of results from a real-world evidence (RWE) study, adolescents with migraine who used the remote electrical neuromodulation (REN) device Nerivio (Theranica, Bridgewater, NJ) at least 10 times in 1 month experienced a significant month-to-month decrease in monthly migraine treatment days (MMTD) for the subsequent 2 months. Participants also showed improved secondary endpoints for efficacy, with no serious or systemic adverse events (AEs). In 2019, the Food and Drug Administration (FDA) authorized Theranica to market Neurivio following its de novo classification, and in 2022, the FDA expanded the indication of the device for the treatment of acute migraine in adolescents.

The study was a prospective RWE analysis (NCT05769322) which included 83 adolescents aged 12-17 years who were frequent users of Neurivio between 2021 and 2023. Frequent use was defined as ≥10 MMTD in 1 28-day month and ≥3 MMTDs in each 2 of the consecutive 28-day months. MMTD was used as a proxy for monthly migraine days (MMD).

Participants showed a significant reduction in MMTD from the first month of Neurivio use (mean: 12.6 MMTD; standard deviation [SD]: ± 3.2 [10 to 23 MMTD]) to the second month (mean: 9.0 MMTD; SD: ± 4.8 [3 to 25 MMTD]) and third month (mean: 7.4 MMTD; SD: ± 4.2 [3 to 19 MMTD]). The decrease in MMTD suggests that participants experienced fewer MMD each subsequent month of Neurivio use.   

During a 2-hour posttreatment period, participants reported the following secondary efficacy endpoint measures:

• 61.9% reported pain relief.
• 24.5% reported pain freedom.
• 67.4% reported relief from functional disability.
• 41.3% reported functional disability freedom.
• 65.9% reported the disappearance of nausea/vomiting.
• 50.0% reported the disappearance of phonophobia.
• 39.6% reported the disappearance of photophobia.