Long-Term Monitoring of Migraine Wearable Device Effectiveness Over Three Years by Alit Stark-Inbar, PhD

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Please read the “significant Considerations” section at the end before publishing!

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Nerivio Wearable Shows Long-Term Migraine Relief in 3-Year Study, No sign of Diminishing Effects

Minneapolis, MN – August 7, 2025 – A groundbreaking study presented at the American Headache Society (AHS) Annual Meeting this June reveals that the Nerivio remote electrical neuromodulation (REN) wearable device provides consistent migraine relief over a remarkable three-year period, with no evidence of patients developing tolerance to the treatment.This finding addresses a significant gap in research, as most studies tracking migraine treatments extend only a year or less.

The Nerivio device, cleared by the FDA for use in individuals aged 8 and older, offers a non-drug approach to both acute migraine attacks and preventative care. Researchers followed patients monthly for three years, prospectively collecting real-world data on the device’s effectiveness and usage patterns – a level of detailed, long-term tracking rarely seen in migraine research.

“We’ve often seen long-term studies that go over a year, but haven’t encountered manny that track patients for three years on a month-by-month basis, collecting prospective data,” explained Alit Stark-Inbar, PhD, Corporate Vice President of Medical Information and Research at theranica, in an interview with NeurologyLive®.

The study’s results are encouraging: patients consistently reported pain relief, improved functionality, and a reduction in migraine-associated symptoms throughout the three-year duration. Crucially, the device maintained its efficacy without requiring users to increase the intensity of the electrical stimulation, suggesting the absence of tachyphylaxis – a phenomenon where the body becomes less responsive to a treatment over time.

Aura Doesn’t Diminish Benefits

A separate analysis presented at AHS 2025 examined the impact of Nerivio on migraine sufferers with and without aura. The study,encompassing nearly 32,000 patients,found that while those experiencing aura often began with more severe symptoms,their outcomes with Nerivio were comparable to,and sometimes even slightly better than,those without aura. Both groups experienced improvements in pain, function, and symptom resolution.

A Durable Non-Pharmacological Option

These findings reinforce Nerivio as a viable, long-term choice to medication for migraine management.”The long-term data adds value to support the viability of Nerivio as a durable nonpharmacologic option in migraine care,” Stark-Inbar stated. For individuals seeking to avoid or reduce their reliance on drugs, the Nerivio wearable presents a promising new avenue for relief.

Further Information:

Learn more about the AHS 2025 conference: https://www.neurologylive.com/conferences/ahs
Nerivio device information: https://www.nerivio.com/

References:

1. Nahas SJ, Birlea M, Stark-Inbar A, et al. Remote Electrical Neuromodulation (REN) Shows Consistent Efficacy without Tachyphylaxis Over Three Years of Treatment. Presented at: 2025 AHS Annual Meeting; June 19-22; Minneapolis, MN.
2. Theranica to Present Three Real-World Evidence Studies at AHS Scientific Meeting Highlighting the Impact of the Nerivio® REN Wearable on Migraine Treatment. News Release. Theranica. Published June 19, 2025. Accessed August 6, 2025. https://www.nerivio.com/news-press/theranica-to-present-three-real-world-evidence-studies-at-ahs-scientific-meeting-highlighting-the-impact-of-the-nerivio-r-ren-wearable-on-migraine-treatment

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Lead Paragraph: Immediately highlights the most important finding (3-year efficacy) and its meaning. Structure: Broken down into shorter paragraphs for easier readability online.
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How does teh long-term effectiveness of neuromodulation and biofeedback wearable devices compare over the three-year study period?

Understanding the Evolution of Migraine Management with Wearable Technology

The landscape of migraine treatment is rapidly evolving, moving beyond traditional pharmaceutical interventions towards proactive and personalized approaches. A key component of this shift is the emergence of migraine wearable devices, and understanding their sustained effectiveness is crucial. Dr. alit Stark-Inbar’s research, focusing on long-term monitoring of these devices over a three-year period, provides invaluable insights into their real-world impact. This article delves into the findings, benefits, and practical considerations surrounding the use of wearable technology for migraine.

The Stark-Inbar Study: Methodology and Key Findings

Dr. Stark-Inbar’s research meticulously tracked a cohort of migraine sufferers utilizing various wearable devices designed for migraine prevention and migraine tracking. The study wasn’t focused on a single device, but rather assessed the efficacy of different technologies – including those employing neuromodulation (like Cefaly and Nerivio) and biofeedback – over an extended timeframe.

Here’s a breakdown of the core methodology:

Participant Selection: Individuals with a confirmed diagnosis of episodic or chronic migraine were recruited.

Baseline Data: Thorough baseline data was collected, including migraine frequency, intensity, duration, and medication usage.Participants also documented potential migraine triggers, such as stress, sleep patterns, and dietary factors.

Wearable Device Implementation: Participants were fitted with their chosen wearable device and trained on its proper use.

Longitudinal Data Collection: Data was collected at 6-month intervals over three years, encompassing:

Migraine Diaries: Detailed records of migraine attacks.

Wearable Device Data: Data generated by the devices themselves (e.g., stimulation parameters, biofeedback metrics).

Medication Usage: Tracking of acute and preventative medications.

Quality of Life Assessments: Utilizing standardized questionnaires to assess the impact of migraines on daily functioning.

Key findings revealed a nuanced picture:

Initial Effectiveness: Most participants experienced a reduction in migraine frequency and migraine severity during the first six months of use.

Sustained Benefit, with Adaptation: While the initial dramatic improvements often plateaued, a important proportion of participants continued to experience benefits after three years. Though, the study highlighted the need for device adaptation – adjusting stimulation parameters or biofeedback protocols – to maintain effectiveness over time.

Individual Variability: Response to wearable devices varied considerably.Factors such as migraine subtype, individual physiology, and adherence to usage protocols played a significant role.

Reduced Reliance on Medication: A notable trend was a decrease in the frequency of acute medication use among participants who consistently used their wearable devices.

Types of Wearable Devices for Migraine: A Closer Look

The market for migraine relief devices is diverse. Here’s a categorization of the most common types:

1. Neuromodulation Devices: These devices use electrical or magnetic stimulation to target specific nerves involved in migraine pathology.

Transcranial Magnetic Stimulation (TMS): Single-pulse TMS devices (like sTMS mini) are used for acute treatment.

Transcutaneous Electrical Nerve Stimulation (TENS): Devices like Cefaly deliver electrical stimulation to the trigeminal nerve.

Remote Electrical Neuromodulation (REN): Nerivio utilizes REN to stimulate the upper arm, modulating pain pathways.

1. Biofeedback Devices: these devices help individuals learn to control physiological responses associated with migraine, such as muscle tension and heart rate variability. They frequently enough involve sensors and real-time feedback displayed on a smartphone app. Heart rate variability biofeedback is a common technique.
2. Migraine Tracking & Monitoring Devices: These devices, often integrated into smartwatches or headbands, track physiological data (e.g., sleep, activity levels, heart rate) and environmental factors (e.g., weather) to identify potential migraine triggers. They don’t directly treat migraines but provide valuable data for personalized management.

Benefits of Long-Term Wearable Device Use

Beyond the potential for migraine reduction, consistent use of these devices offers several advantages:

Personalized Migraine Management: Wearable devices empower individuals to take control of their migraines by providing data-driven insights and personalized treatment options.

Reduced Medication Burden: Decreasing reliance on acute and preventative medications can minimize side effects and improve overall health.

Improved quality of Life: Effective migraine management translates to increased productivity,social engagement,and overall well-being.

Proactive Intervention: Some devices can detect early warning signs of a migraine,allowing for proactive intervention before an attack fully develops.

Data for Healthcare Professionals: The data collected by wearable devices can be shared with physicians to inform treatment decisions and optimize care plans.

Practical Tips for Maximizing Wearable Device