No statistical differences were found between REN and the standard of care medications, in any of the effectiveness outcomes of pain single-treatment pain relief and pain freedom, nor in consistency of pain relief and pain freedom.
Findings from 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-of-care medications in outcomes for patients with chronic migraine. These data suggest that REN may serve as a nonpharmacological alternative for this patient population.1,2
In a cohort of 78 adults with chronic migraine, 62.8% (49 of 78) of REN-treated patients demonstrated significant single-treatment pain relief 2 hours after initiating treatment, as opposed to only 48.7% (38 of 78) of those on standard care (P = .056). Additional results showed that 64.1% of the patients achieved constant pain relief with REN, compared with 57.7% of those on standard-care medications (P = .369).
"Chronic migraine is an especially disabling condition, diagnosed when a migraine patient experiences at least 15 migraine-induced headache days per month,” primary investigator Brian Grosberg, MD, director, Hartford Healthcare Headache Program, said in a statement.1 "The recent Consensus Statement of the American Headache Society 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 medication use to an average of two headache days per week."
In October 2020, Nerivio became the first FDA-cleared smartphone-controlled prescribed wearable device for the acute treatment of migraine. Since then, it has received additional authorization for 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 utilizes REN to trigger an endogenous analgesic mechanism, known as conditioned pain modulation.
Grosberg added, "Chronic migraine patients often have 4, 5, or even 6 headache days per week. To treat them effectively and safely we must expand the first-line standard-care treatment options beyond prescribed medications. This research provides a strong comparison of REN to prescribed medications, mainly triptans, reinforcing the conclusion that REN provides a much-needed alternative to standard-care acute migraine treatment—without compromising effectiveness."1
Findings from the study also showed that single treatment pain relief was achieved in 23.1% of those with chronic migraine treated with Nerivio, vs 19.2% of those with standard medication use (P = .532). Notably, both REN and standard of care medications achieved 14.1% consistency of pain freedom across multiple treatments (P = 1.00).
In October 2021, Theranica published data from a prospective, open-label trial (NCT04194008) aimed to validate and provide further evidence on the safety and effectiveness 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 at 2 hours posttreatment as the primary end point. Pain freedom and improvement of associated symptoms and functional disability were secondary end points. Of the 91 individuals who had evaluable treatment with REN, 54 (59.3%) achieved pain relief and 19 (20.9%) achieved pain disappearance at 2 hours. Additionally, 64.4% of those who achieved pain relief at that time point had sustained pain relief at 24 hours following treatment.3
Earlier this year, in February, a dual-arm study published in Pain Medicine highlighted Nerivio REN’s efficacy when combined with the Nerivio’s Guided Imagery, Education and Relaxation (GIER) optional in-app behavioral intervention. All told, at 2 hours post-treatment, the REN+GIER group displayed statistically significantly higher proportion of patients who achieved consistent pain relief (P = .008), consistent improvement in function (P = .014), and consistent return to normal function (P = .005) than the REN-only group.4