11 Jan 2022
5 min read

Three Years In: What Long-Term, Real-World Data Reveals About Nerivio® REN Consistency

Migraine care isn't about whether a therapy works on day one, but if it works on day one thousand. Migraine demands treatments that remain effective, tolerable, and compatible with the rest of their health needs.

One of the biggest unanswered questions in migraine care is not whether a therapy works on day one, but whether it continues to work on day one thousand. For many patients, migraine is not a temporary inconvenience. It is a chronic neurologic condition that spans decades and demands treatments that remain effective, tolerable, and compatible with the rest of their health needs.

A new three-year real-world evidence study published in Headache now gives us something rare in this landscape: Long-term data capturing how patients actually use and respond to REN over time. The findings shed light on a pattern clinicians are often forced to infer but seldom get to see clearly: does the therapy hold up?

The Durability Question

Tachyphylaxis remains a barrier in chronic therapeutic management. The need to escalate dose or intensity over time often reflects the simple truth that some treatments lose steam. In this study of 224 U.S. patients who used the Nerivio® REN wearable consistently for three years, treatment intensity barely shifted. Average intensity rose only 3.2 units on a 100 unit scale across the entire study period, with no clinically meaningful changes between consecutive years. This met the predefined endpoint for lack of tachyphylaxis.

Subgroup analyses across prevention-like users, acute users, and participants from earlier cohorts all confirmed the same pattern. The therapeutic effect did not decay, and the device did not need to work harder to achieve the same outcomes. For clinicians managing chronic migraine, this level of stability is not just statistically relevant. It is clinically valuable.

Consistency That Extends Beyond Intensity

Effectiveness stayed steady across the full three years. Pain relief remained in the range of 72 to 77 percent. Pain freedom hovered between 26 and 29 percent. Functional disability relief remained between 65 and 71 percent, and functional disability freedom ranged from 31 to 39 percent. Relief from photophobia, phonophobia, and nausea also showed no year-over-year decline.  

These are the types of metrics patients watch closely. They reflect how much of their day they can reclaim, how often they can stay present at work or school, and how many times they can avoid the spiraling secondary effects of untreated or undertreated attacks. Stability across these outcomes suggests that REN is not only effective in the short term but dependable in the long run.

Real-World Adherence Tells Its Own Story

Monthly average utilization stayed consistent, with patients using the device between eight and nine times per month on average. This pattern matters for a simple reason: Patients do not continue treatments that stop working or introduce burdensome effects. Real-world adherence is often the clearest indicator of whether a therapy is meeting patient expectations. Here, it reinforces the overall picture of long-term dependability.  

Safety outcomes aligned with previous Nerivio REN data. Only two device-related adverse events occurred in three years, both nonserious. Both participants continued treatment.

Why These Findings Matter for Patient Care

The real-world nature of this study is part of its strength. These were not tightly controlled trial conditions. These were patients navigating their own life schedules, comorbidities, competing priorities and the normal fluctuations of life. The consistency of the findings under these conditions strengthens the clinical relevance.

For healthcare providers seeking long-term solutions that do not require dose adjustments, monitoring for cumulative exposure, or complex medical interactions, Nerivio REN offers a stable and reliable option.

It also addresses a growing clinical need. Many patients benefit from pharmacological tools, but long-term side effects, tolerability changes, and diminishing efficacy can complicate sustained use. The ability to pair or alternate with a drug-free option that shows no tachyphylaxis and maintains effectiveness over years creates more flexibility when designing individualized treatment plans.

A Path Forward

This three-year publication adds weight to an already expansive evidence base behind REN and offers one of the longest real-world views of neuromodulation in migraine care. For clinicians, the takeaway is straightforward: REN was shown to remain effective over time. Patients can rely on it without needing to push intensity higher. And long-term adherence reflects a treatment pattern that fits into real life rather than fighting against it.  

As the field moves toward more sustainable migraine management strategies, long-term consistency will likely become a non-negotiable expectation. Nerivio REN is now one of the few therapies with data showing it can meet that bar.

References:

1. Nahas et al., Headache, 2025