The Nerivio REN Wearable: A Deep Dive into Non-Drug Migraine Relief

Migraine remains one of the most disabling neurological conditions worldwide, affecting over one billion people and ranking among the leading causes of disability across all diseases. For decades, pharmaceutical interventions like triptans and nonsteroidal anti-inflammatory drugs dominated acute migraine treatment, yet many patients continue to struggle with inadequate relief, intolerable side effects, medication overuse headaches, or contraindications that prevent traditional medication use. In this landscape, the Nerivio REN wearable device represents a meaningful shift toward non-pharmacological alternatives, offering patients a genuinely different approach to managing their migraines. This article explores the science behind the device, examines its real-world effectiveness, addresses its limitations, and helps you understand whether this technology might fit your migraine management strategy.

What is the Nerivio REN Wearable?

Nerivio is a prescription wearable device manufactured by Theranica Bio-Electronics that uses remote electrical neuromodulation technology to treat and prevent migraine attacks. The device received its initial FDA de novo clearance in May 2019 for acute migraine treatment in adults, expanded approval in October 2020 for chronic migraine patients aged 18 and older, further expansion in January 2021 to include adolescents aged 12 to 17 years, FDA clearance for preventive treatment in February 2023, and most recently, approval for children as young as 8 years old in November 2024. These sequential approvals reflect not only accumulating safety and efficacy data but also growing recognition of Nerivio's role in addressing critical unmet needs in pediatric and adolescent migraine care, where medication-averse families and young patients increasingly seek non-pharmacological options.

The physical device resembles a medical armband roughly the size of a smartphone and attaches to the upper arm using a comfortable sleeve. Each Nerivio device contains a proprietary microprocessor and electrode system designed to deliver carefully calibrated electrical pulses. The device connects wirelessly via Bluetooth to a smartphone application that controls the intensity, duration, and delivery of stimulation. Each Nerivio device provides 12 individual 45-minute treatment sessions before requiring replacement or refilling. The entire treatment initiation involves placing the device on your upper arm, securing it with the included armband, connecting it through the smartphone app, and starting the session—a process that takes several minutes but allows you to continue your daily activities during treatment.

The Science Behind Remote Electrical Neuromodulation

Understanding how Nerivio works requires grasping a fundamental concept in pain neuroscience called conditioned pain modulation, or CPM. The human brain possesses an intrinsic capability to suppress pain through endogenous mechanisms, essentially turning pain off using the body's own chemical and neural systems. When you experience pain in one area of your body, that pain can paradoxically reduce pain perception in another area this is the CPM reflex in action. Research indicates that individuals with migraine may have a diminished or impaired CPM response, meaning their brain's natural pain inhibition system doesn't function optimally. Nerivio's fundamental strategy is to activate this weakened CPM system artificially.

The device works by stimulating specific nerve fibers in the upper arm called Aδ (A-delta) and C fibers through non-painful electrical pulses. These nociceptive fibers, when appropriately stimulated, send ascending signals to pain regulation centers in the brainstem, particularly structures including the periaqueductal gray matter, rostral ventromedial medulla, and trigeminal cervical complex. This ascending stimulation triggers the activation of descending pain inhibitory pathways, which release neurotransmitters including serotonin and norepinephrine into the spinal cord and trigeminal system. These neurotransmitters effectively dampen pain signal transmission, reducing or eliminating the headache and associated migraine symptoms. Recent 2025 research confirms that this mechanism represents a partial remission of pain inhibition dysfunction, suggesting that with persistent use, patients may experience increasingly robust endogenous pain modulation.

Importantly, Nerivio differs fundamentally from transcutaneous electrical nerve stimulation (TENS) devices, which work through a different mechanism. TENS units primarily use surface electrodes to deliver electrical current that may block pain signals through gate control mechanisms or peripheral effects. Nerivio's REN technology, by contrast, deliberately activates specific peripheral nerve fibers to engage the brain's central pain modulation systems. This distinction explains why Nerivio can affect migraine pain globally, not just locally where the device is positioned, and why it works for associated symptoms like nausea and light sensitivity that originate from central nervous system dysfunction rather than peripheral sources. This fundamental difference positions Nerivio in the same mechanistic class as CGRP monoclonal antibodies—both target central pain processing systems—though through entirely different biological pathways.

Acute Migraine Treatment

In the pivotal randomized controlled trial for acute migraine treatment, pain relief at two hours post-treatment was achieved in 66.5 percent of Nerivio-treated patients, compared to 37.5 percent in the sham control group. Pain freedom (complete resolution of headache) occurred in 42 percent of active treatment patients versus 19 percent in the sham group. These results position Nerivio's efficacy in the range of triptan medications, with many triptans showing pain relief rates of 50 to 70 percent across different formulations and patient populations.

For chronic migraine specifically, a dedicated study of 91 patients found that 59.3 percent achieved pain relief and 20.9 percent achieved complete pain freedom at two hours post-treatment. Notably, this represents effectiveness despite chronic migraine patients' typically lower medication responsiveness due to central sensitization and altered pain processing. A particularly informative comparison study examined 78 chronic migraine patients who treated their attacks with standard medications for one month, then switched to Nerivio alone for the following month. The results demonstrated that 62.8 percent of patients achieved pain relief with Nerivio compared to 48.7 percent with their previous medications. Additionally, 64.1 percent achieved consistent pain relief with Nerivio across multiple treatments versus 57.7 percent with medications, and 23.1 percent achieved pain freedom with Nerivio versus 19.2 percent with medications.

Pediatric and Adolescent Efficacy

Given the concerning rates of medication side effects in young people and their strong preference for non-pharmaceutical solutions, pediatric and adolescent efficacy data carries particular weight. In a real-world analysis of over 13,700 treatments in adolescents aged 12 to 17 years, 72.2 percent reported consistent headache relief and 36 percent reported consistent freedom from headache at two hours post-treatment. In a direct comparison of adolescents who had previously used oral triptans and over-the-counter medications, pain freedom with Nerivio was achieved in 37.1 percent of treatments compared to only 8.6 percent with standard care medications, a statistically significant difference. Pain relief was achieved in 71.4 percent with Nerivio versus 57.1 percent with medications.

For younger children aged 6 to 11 years, the FDA examined real-world data from 293 children conducting 5,493 treatments. The results mirrored those seen in adolescents with 72.2 percent reporting consistent headache relief and 36 percent reporting consistent freedom from headache. Notably, children required lower stimulation intensity (average 22.8 percent of maximum) compared to adults (28.5 percent), yet achieved comparable efficacy rates despite this lower intensity. Remarkably, no adverse events were reported in this pediatric population, suggesting excellent tolerability even in very young users.

Preventive Treatment

The preventive indication represents a more recent and equally important development. In a randomized, placebo-controlled trial of 248 patients using Nerivio every other day for eight weeks as preventive therapy, patients receiving active treatment experienced a mean reduction of 4 migraine days per month compared to 1.3 days reduction in the placebo group, yielding a net therapeutic gain of 2.7 migraine days per month. Additionally, the active group achieved significant reductions in moderate to severe headache days and acute medication usage days. Fifty-five percent of Nerivio-treated patients achieved at least 50 percent reduction in headache days compared to 30 percent in the placebo group.

One critical concern with any chronic treatment is whether effectiveness diminishes over extended use. The phenomenon of tachyphylaxis, where the body adapts to a treatment and requires increased doses or intensity for the same effect, represents a major limitation of some medications. A landmark three-year real-world evidence study published in Headache examined 224 patients who used Nerivio monthly for migraine attacks over three years. Tachyphylaxis was defined as an increase of more than 2.5 units on a 100-unit stimulation intensity scale over one year, representing clinically meaningful dose escalation. The study found no evidence of tachyphylaxis across the three-year observation period. Pain relief remained stable, with 74.1 percent of users reporting consistent pain relief at two hours post-treatment in year one, with no significant changes in subsequent years. This absence of tachyphylaxis is particularly advantageous when compared to certain pharmaceutical treatments that lose effectiveness with time.

Symptomatic Relief Beyond Headache Pain

Migraine encompasses far more than headache pain. Associated symptoms including nausea, vomiting, photophobia, and phonophobia often cause significant disability independent of pain intensity. In a one-year real-world evidence study, the percentage of patients reporting disappearance of associated symptoms at two hours post-treatment included 70.8 percent for nausea and vomiting, 52.7 percent for phonophobia, and 43.2 percent for photophobia. Among patients with at least one associated symptom at treatment initiation, 73.5 percent reported disappearance of at least one symptom. This broad symptomatic relief reflects Nerivio's global impact on pain modulation systems rather than a narrowly targeted effect.

Safety Profile and Tolerability

The safety profile of any medical device significantly influences its place in clinical practice, and Nerivio's safety data, accumulated across thousands of treatments and multiple studies, presents a notably favorable picture. In the one-year real-world evidence study of 409 patients conducting nearly 40,000 treatments, device-related adverse events occurred in only 1.96 percent of patients. Among these events, the distribution was as follows: two negligible events (0.49 percent of patients), five mild events (1.22 percent), one moderate event (0.24 percent), and zero severe events. No serious adverse events were reported. The most common adverse events involved local paresthesia or skin sensitivity at the device application site, essentially temporary tingling or altered sensation on the upper arm. Importantly, all patients who experienced adverse events continued using the device, indicating that the discomfort, when present, remained tolerable and was outweighed by treatment benefits.

This safety profile contrasts sharply with many pharmacological migraine treatments. Triptan medications commonly cause systemic side effects including nausea, dizziness, somnolence, and chest tightness. Nonsteroidal anti-inflammatory drugs used chronically increase risks of gastrointestinal bleeding, renal dysfunction, and cardiovascular events. Newer preventive medications like the CGRP-receptor antagonists (gepants) and monoclonal antibodies targeting CGRP have demonstrated efficacy but also bring treatment-emergent adverse events. Rimegepant users experience upper respiratory infection, nasopharyngitis, and back pain in 4.3 to 7.1 percent of patients, while atogepant use is associated with upper respiratory infection, constipation, nausea, and urinary tract infections in 6.3 to 10.3 percent of patients. Recent spontaneous adverse event reports to the FDA for CGRP monoclonal antibodies include significant rates of alopecia. By comparison, Nerivio's local, mild, temporary side effects at the application site represent a minimal safety burden.

A major distinction between Nerivio and pharmaceutical treatments is the complete absence of systemic adverse effects. Because Nerivio works locally on peripheral nerve fibers to activate endogenous brainstem mechanisms, it does not enter the systemic circulation, does not undergo hepatic metabolism, and does not produce medication-drug interactions or contraindications related to other diseases or medications. This safety advantage particularly benefits patients with cardiovascular comorbidities who cannot tolerate triptans, patients on complex medication regimens, pregnant or nursing women, and adolescents who prefer to minimize medication burdens.

Pregnancy and Postpartum Safety

A significant population of migraine patients are of childbearing age, and treatment options become substantially restricted during pregnancy due to teratogenic concerns with most medications. A 2023 real-world evidence study examining pregnant women and those in the postpartum period (up to three months after delivery) found Nerivio to be safe and effective during this critical period when medication options become substantially more limited. The absence of systemic absorption and lack of medication metabolites crossing the placenta or entering breastmilk make Nerivio uniquely suited for pregnant and nursing migraine patients—a population for whom treatment options are often restricted to non-pharmacological approaches.

Using Nerivio in Real Life

Using Nerivio involves several sequential steps that require awareness and attention during migraine attacks when cognitive function may be compromised. First, you locate your Nerivio device, which comes preloaded with 12 treatment sessions. You then position the device on your upper arm, roughly mid-forearm to mid-shoulder, secure it with the soft armband provided, press the power button on the device, open the Nerivio smartphone application, wait for Bluetooth pairing to establish connection, and finally initiate the treatment through the app. During this setup process, you adjust the stimulation intensity to a level that feels well-perceived but not painful, typically somewhere around 30 to 50 percent of maximum output based on real-world data showing an average stimulation intensity of 28.5 percent of maximum.

Each treatment session lasts 45 minutes. During this time, you can continue normal activities, reading, watching videos, lying down to rest, working, or anything else that doesn't require upper arm movement. The stimulation produces a sensation most users describe as mild tingling or vibration in the arm, generally well-tolerated and not painful. The smartphone app allows you to adjust intensity throughout the session if needed and provides a built-in digital migraine diary where you can record your symptoms before treatment, at treatment initiation, and two hours after treatment completion.

Device Refills, Prescription Management, and Insurance Coverage

Each device comes preloaded with 12 treatment sessions. After exhausting all 12 treatments, you cannot simply recharge the device; instead, you obtain a new Nerivio device. In the United States, the system operates through prescription refills. When prescribed Nerivio, your healthcare provider writes a prescription specifying a quantity of devices (for example, "Qty: 3 devices per month"). You then fill this prescription through a pharmacy, similar to how you would refill a medication prescription.

Insurance Coverage Expansion (May 2025): Insurance coverage for Nerivio has expanded dramatically. As of May 2025, Anthem Blue Cross Blue Shield, the second-largest health insurance company in the United States announced comprehensive coverage for Nerivio, extending to approximately 80 million insured Americans across 20 states. This represents a more than doubling of coverage from approximately 30 million Americans in late 2024. Anthem's decision represents the first major commercial insurance carrier to provide broad coverage for a non-pharmacological migraine wearable, potentially catalyzing similar decisions among other major insurers. Beyond commercial insurance, coverage extends to Medicaid programs in multiple states and the Department of Veterans Affairs. However, coverage remains heterogeneous some state Medicaid programs provide full coverage, others restrict access to refractory cases, and geographic variation persists even within major insurance companies due to regional medical policy differences. Patients and providers should verify coverage through the Nerivio coverage checker tool or direct contact with insurance providers rather than assuming coverage or lack thereof based on general information.

Cost to Patients: The cost to you depends on your insurance coverage and any patient assistance programs. For patients with Anthem or other commercial insurance covering Nerivio, typical copays range from $20-50 per device, translating to approximately $240-600 annually for moderate-frequency users. For patients without insurance coverage, the retail cost of a single Nerivio device is approximately $100, though Theranica offers a patient savings program reducing the cost to $10 for the first device and providing substantial discounts for subsequent devices. When considering cost, it's worth noting that each device provides 12 treatments, and real-world data shows average monthly usage of approximately 8 treatments per month for acute treatment, meaning each device lasts roughly one to two weeks for frequent migraine sufferers. For context, patients with episodic migraine averaging approximately 4 attacks monthly would require roughly 3-4 devices per month, translating to monthly costs of approximately $30-40 with the patient savings program, or $60-120 with typical insurance copays.

For patients comparing costs with other neuromodulation devices, Nerivio's consumable model differs from competitors: CEFALY costs $509 one-time with indefinite use (though electrode replacement costs $20-40 annually); gammaCore operates on a supply model costing approximately $750 for a 3-month supply; and SAVI Dual involves variable pricing. For patients with high-frequency migraine (8+ attacks monthly), Nerivio's consumable model may require 1-2 devices per week, making insurance coverage or patient assistance programs essential for affordability. Conversely, frequent users benefit from higher-volume prescription options, with many insurance plans covering 2-4 devices monthly for chronic migraine patients.

Nerivio's Position in the Neuromodulation Device Landscape

Nerivio exists within an expanding ecosystem of FDA-cleared neuromodulation devices for migraine, each with distinct mechanisms, efficacy profiles, and practical advantages. Understanding how Nerivio compares to alternatives helps patients and providers select the most appropriate device for individual circumstances.

Device Selection Considerations:

• SAVI Dual represents the optimal choice for patients with aura-predominant migraine, as it specifically targets the visual cortex and addresses the cortical spreading depression mechanism underlying visual aura. Its extremely fast treatment (<1 second) makes it ideal for patients unable to dedicate 45 minutes to treatment.

• gammaCore remains the only FDA-approved device for treating cluster headache alongside migraine, making it the preferred option for patients with both conditions. Its 2-3 minute treatment duration and durable design offer convenience advantages over Nerivio.

• CEFALY provides the most affordable long-term option due to its durable design ($509 one-time cost), though it requires ongoing electrode purchases. It represents an excellent choice for budget-conscious patients with lower treatment frequency.

• Nerivio offers the most comprehensive approval profile (both acute and preventive treatment), the largest real-world evidence base (55,261 patients in 2025 study), and the strongest efficacy data for preventing migraine days monthly. It represents the optimal choice for patients requiring preventive treatment or those optimizing for outcomes rather than convenience.

• Relivion MG achieves the highest single-treatment efficacy (46% pain freedom) but remains approved only for acute treatment and is the newest device with the most limited real-world evidence.

These devices are not mutually exclusive. Patients may employ combination strategies, using one device for acute treatment and another for prevention, or sequentially trying multiple devices to identify optimal fit.

The Economic Value of Nerivio Treatment

Beyond clinical efficacy, economic analyses have quantified Nerivio's value proposition for patients, insurers, and employers. A 2023 cost-effectiveness study published in Headache estimated mean annual cost-savings of $10,000 per patient using Nerivio for migraine prevention, derived from reductions in migraine days, medication usage, healthcare visits, and indirect costs from missed work or reduced productivity. Extrapolating to a hypothetical US commercial health plan covering one million individuals, estimated annual savings would reach $560 million in combined direct and indirect costs, composed of $327.8 million in direct medical cost reductions and $232.2 million in indirect productivity gains.

For context, preventive migraine treatments differ substantially in cost profiles:

• Botulinum toxin (BOTOX): ~$2,923 annually (NICE analysis)

• Topiramate + other off-label preventives: $2,000-5,000 annually

• CGRP monoclonal antibodies: $6,000-9,000 annually before insurance negotiations

• Nerivio: $480-960 annually with typical insurance copay rates

The Advantages That Matter

For patients unable or unwilling to take migraine medications, Nerivio provides a genuinely drug-free alternative. This includes patients with contraindications to specific medications, those experiencing intolerable side effects, individuals with complex polypharmacy where drug interactions become concerning, pregnant or breastfeeding women, and adolescents and their families who simply prefer non-pharmaceutical management. Nerivio's effect on the brain's global pain modulation system explains why it effectively reduces not just headache pain but also associated migraine symptoms. Patients report relief from photophobia, phonophobia, nausea, and vomiting in substantial proportions, addressing the multifaceted disability of migraine rather than targeting pain alone.

The three-year longitudinal evidence demonstrating no development of tachyphylaxis addresses a critical concern in chronic migraine management. Patients can confidently use Nerivio long-term without worry that its effectiveness will diminish or that escalating treatment intensity will become necessary. FDA approval extending from age 8 through adulthood, combined with robust clinical data in pediatric, adolescent, and adult populations, makes Nerivio relevant across nearly all age groups affected by migraine. Adolescents and young children particularly benefit from a non-pharmacological option aligned with their treatment preferences.

The 2025 finding regarding early treatment timing offers actionable optimization guidance unavailable with most migraine medications. By recognizing prodromal symptoms and treating within the critical one-hour window, patients can potentially achieve dramatically superior outcomes (65% vs. 47% pain relief; 29% vs. 15% pain freedom). This timing advantage may explain much of the heterogeneity in reported outcomes and provides a concrete strategy for improving treatment success.

Nerivio can be used alone as a standalone migraine treatment or combined with acute medications or preventive therapies as patients' needs require. Real-world data show that approximately 64 percent of adolescent treatments involved Nerivio as standalone therapy, 18.6 percent combined with over-the-counter medications, and 17 percent combined with prescription medications, giving users flexibility to construct individualized treatment strategies. The dual-use approval for both acute and preventive treatment using the same device simplifies migraine management. Patients can use Nerivio at migraine onset for acute relief or employ it every other day for preventive purposes, potentially reducing the number of devices and the complexity of treatment regimens. With adverse events occurring in fewer than 2 percent of patients, and the vast majority of those being mild, Nerivio demonstrates tolerability that allows nearly all patients who try the device to continue using it without discontinuation due to side effects.

Where Nerivio Falls Short

While efficacy data is encouraging, Nerivio does not work for every person with migraine. Approximately one-third of patients do not experience meaningful pain relief, consistent with general migraine treatment effectiveness where no single intervention is universally effective. Trial dropout and real-world discontinuation reflect this heterogeneity in treatment response.

Placing the device, securing the armband, establishing Bluetooth connection, and adjusting stimulation intensity requires multiple cognitive steps and fine motor coordination, capabilities that may be compromised during moderate to severe migraine attacks. Patients with severe cognitive impairment during attacks may find setup burdensome. Simplification of the setup process remains an area for device improvement. The 45-minute treatment duration exceeds the treatment administration time of oral or intranasal medications, potentially limiting use in situations requiring immediate relief when a person cannot dedicate three-quarters of an hour to treatment. Competing devices like gammaCore (2-3 minutes) or SAVI Dual (<1 second) offer faster alternatives.

While uncommon and typically mild, local paresthesia at the stimulation site or temporary skin redness can occur. For a minority of patients, these local effects may become bothersome with repeated treatments, though real-world data indicate most patients find these effects tolerable. Limited insurance coverage in some regions creates substantial out-of-pocket costs for patients, though the May 2025 Anthem expansion substantially improved this situation for many Americans.

The requirement for prescription refills every one to two weeks demands careful coordination with healthcare providers and pharmacies. The inability to simply recharge the device and the requirement to physically replace it every 12 treatments differs from traditional reusable migraine devices and may be perceived as wasteful or inconvenient by some patients, though the device can be recycled upon disposal. Individual arm anatomy varies, and optimal electrode placement requires understanding the correct positioning on the upper arm. Suboptimal placement can reduce effectiveness, and the existing guidance using cartoon diagrams rather than detailed anatomical landmarks has been noted by users as insufficient.

Putting Nerivio Into Clinical Context

Nerivio represents a legitimate alternative to triptan medications and NSAIDs for acute migraine treatment, particularly for patients experiencing inadequate relief, intolerable side effects, or medication contraindications. Comparative data suggesting effectiveness equal to or potentially exceeding many triptans, combined with a superior safety profile, positions it as a first-line option for these populations.

The February 2023 FDA clearance for preventive use, backed by evidence of 2.7 migraine days per month net reduction compared to placebo, adds Nerivio to the expanding preventive migraine arsenal alongside medications and other neuromodulation devices. The 2025 study of 55,261 patients demonstrating the critical importance of early treatment provides actionable guidance for optimizing outcomes. Patients with chronic migraine who have developed medication-overuse headache from excessive acute medication use can potentially benefit from Nerivio's non-pharmacological approach, reducing their medication frequency during headache detoxification periods.

The absence of systemic side effects, combined with clinical efficacy and adolescents' stated preference for drug-free options, makes Nerivio particularly attractive for younger populations where minimizing medication exposure is often a priority. Rather than requiring a choice between Nerivio and medications, many patients benefit from a "migraine toolbox" approach incorporating Nerivio alongside preventive medications or acute medications, allowing flexibility to select the most appropriate treatment for each specific attack.

The May 2025 insurance expansion to 80 million Americans through Anthem coverage, combined with the company's patient assistance program ($10 first device), substantially improves accessibility and removes cost barriers for many patients who previously faced prohibitive out-of-pocket expenses.

Conclusion

The Nerivio REN wearable represents a meaningful advancement in non-pharmacological migraine treatment, backed by a robust evidence base spanning randomized controlled trials, pediatric studies, and extensive real-world evidence derived from over 586,000 individual treatments as of 2025. Its mechanism activating the brain's natural pain modulation systems offers a fundamentally different approach compared to conventional migraine medications or competing neuromodulation devices. The clinical evidence demonstrates efficacy comparable to or exceeding many pharmacological treatments, coupled with an exceptionally favorable safety profile free from systemic adverse effects. Three years of longitudinal evidence showing stability and absence of tachyphylaxis addresses critical concerns about long-term treatment viability.

The 2025 landmark finding demonstrating that early treatment initiation nearly doubles clinical efficacy represents actionable optimization guidance that distinguishes Nerivio from most other migraine treatments. By recognizing and responding to migraine onset within the critical one-hour window, patients can substantially improve their likelihood of successful treatment.

However, Nerivio is not a universal solution. Approximately one-third of patients do not experience meaningful benefit, setup complexity during acute attacks presents practical challenges, and despite recent insurance expansion, coverage barriers persist in some regions. The device functions optimally as a component of comprehensive migraine management rather than as a replacement for all other treatments.

For patients with migraine, discussing Nerivio with a healthcare provider offers the opportunity to explore whether this technology might address your specific migraine burden, particularly if you have experienced inadequate response to or intolerance of conventional treatments. The rapidly evolving evidence base including recent large-scale studies demonstrating the critical importance of early treatment initiation and expanding insurance coverage now reaching 80 million Americans suggests that wearable neuromodulation devices will increasingly become part of standard migraine care, offering patients options that were simply unavailable a decade ago.

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