Neuromodulation Device Effective for Most Migraine Sufferers
/By Pat Anson, PNN Editor
A wearable neuromodulation device significantly reduced headache pain in nearly two-thirds of migraine sufferers, according to a new study. About one in four participants (22.6%) who used the device had no migraine pain after two hours.
The study findings, published in the journal Frontiers in Pain Research, are based on an analysis of over 23,000 remote electrical neuromodulation (REN) treatments with Nerivio, a device worn on the upper arm that uses mild electrical pulses to disrupt pain signals.
It’s important to note the study was designed and funded by Theranica Bio-Electronics, Nerivio’s manufacturer. Three of the five co-authors are Theranica employees.
“The current analysis of a very large group of patients, over a long period of time and multiple treatments, reinforces that REN provides a safe, efficacious and stable treatment option for acute treatment of migraine, both as a standalone and as an adjunct therapy. This is a very important component in the migraine therapy toolbox," lead author Jessica Ailani, MD, Director of the MedStar Georgetown Headache Center and Professor of Clinical Neurology, said in a press release.
Nerivio is controlled by a smartphone app that allows patients to set the intensity of their 45-minute treatments at the onset of a migraine. The app also has a migraine diary that allows patients and their doctors to track the effectiveness of REN.
It is from this app that study data was collected from 12,151 U.S. patients from 2019 to 2021. Most had been prescribed REN by headache specialists, indicating their migraines were difficult to treat with pain medication alone. During the study, about two-thirds of patients only used REN, with the remainder continuing to use over-the-counter or prescription medications.
"To the best of our knowledge, this study is the largest prospective real-world evidence analysis of a migraine device to date," said Alon Ironi, CEO of Theranica.
Migraine affects more than 37 million people in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can cause nausea, visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraines than men.
Although migraine sufferers have many new treatments available, such as CBD oil and calcitonin gene-related peptide (CGRP) inhibitors, many find them too expensive or ineffective. Theranica hopes Nerivio can help fill the treatment gap, either as a standalone replacement for medication or as an adjunct.
"While some people with migraine get relief from prescribed or even over-the-counter medications, others do not respond to medications, or cannot tolerate their side effects. There are also people who cannot use medications due to contraindications or being at risk of drug-drug interactions or medication overuse headache,” Ailani said.
The FDA approved Nerivio as a treatment for acute migraine in adults in 2019. Last year the label was expanded to include children over the age of 12 with episodic or chronic migraine. Over 25,000 people in the U.S. have used the device, according to Theranica.
Nerivio is only available by prescription. When purchased wholesale, the listed price is $599 for a twelve-treatment unit, although buyers can save money by enrolling in a patient savings program, depending on their insurance coverage.
