Results of a post-hoc analysis of a study evaluating the Nerivio (Theranica) remote electrical neuromodulation (REN) device showed that the treatment did not differ from standard medications in terms of outcomes for patients with chronic migraine . These data suggest that REN may serve as a non-pharmacological alternative for this patient population.1.2
In a cohort of 78 adults with chronic migraine, 62.8% (49 out of 78) of patients treated with REN demonstrated significant pain relief in a single treatment 2 hours after starting treatment, compared to only 48.7 % (38 out of 78) of those on standard treatment. care (P = 0.056). Additional results showed that 64.1% of patients achieved consistent pain relief with REN, compared to 57.7% of those taking standard care medications (P = 0.369).
“Chronic migraine is a particularly disabling condition, diagnosed when a migraine patient experiences at least 15 days of migraine-induced headaches per month,” said lead researcher Brian Grosberg, MD, director of the Hartford Healthcare Headache Program, in a press release.1 “The American Headache Society’s recent consensus statement recommends that, in order to avoid medication overuse, patients with migraine who need to use acute treatments on a regular basis should be instructed to limit the use of medication to an average of two headache days per week.”
In October 2020, Nerivio became the first FDA-approved smartphone-controlled prescription wearable device for the acute treatment of migraine. Since then, it has received additional approval for the acute treatment of episodic and chronic migraine in adult and adolescent patients. Worn on the upper arm at the onset of a migraine attack, the device uses REN to trigger an endogenous analgesic mechanism, known as conditioned pain modulation.
Grosberg added: “Patients with chronic migraine often have 4, 5 or even 6 headache days per week. To treat them safely and effectively, we need to expand standard first-line treatment options beyond prescribed drugs. This research provides a strong comparison of RENs to prescribed medications, primarily triptans, reinforcing the conclusion that RENs provide a much-needed alternative to standard treatment for acute migraine, without compromising efficacy.”1
Study results also showed that pain relief from a single treatment was achieved in 23.1% of people with chronic migraine treated with Nerivio, compared to 19.2% of people on standard medication (P = 0.532). Notably, RENs and reference medications achieved 14.1% consistency of freedom from pain across multiple treatments (P = 1.00).
In October 2021, Theranica published data from a prospective, open-label trial (NCT04194008) to validate and provide additional evidence for the safety and efficacy of Nerivio in a cohort of 126 patients with chronic migraine treated for 4 weeks. Using an electronic diary to record their symptoms, investigators recorded the percentage of subjects who achieved pain relief 2 hours after treatment as the primary endpoint. Freedom from pain and improvement in associated symptoms and functional disability were secondary endpoints. Of the 91 people who received evaluable treatment with REN, 54 (59.3%) achieved pain relief and 19 (20.9%) achieved pain resolution at 2 hours. Additionally, 64.4% of those who achieved pain relief at this time maintained pain relief 24 hours after treatment.3
Earlier this year, in February, a two-part study published in pain medication demonstrated the effectiveness of Nerivio REN when combined with the optional behavioral intervention in Nerivio’s Guided Imagery, Education and Relaxation (GIER) application. Overall, 2 hours after treatment, the REN+GIER group had a statistically significantly higher proportion of patients who achieved consistent pain relief (P = 0.008), constant improvement in function (P = 0.014), and constant return to normal function (P = 0.005) than the REN group only.4