Electrical Neuromodulation Device Shows Promise as Nonpharmacological Alternative for Chronic Migraine

The Nerivio (Theranica) remote electrical neuromodulation (REN) device showed similar outcomes to standard-of-care medications in patients with chronic migraine, according to data from a post hoc study analysis.1The findings indicate that REN may offer a nonpharmacological treatment alternative for patients who suffer from chronic migraine, according to the study authors.^1,2

"Chronic migraine is an especially disabling condition, diagnosed when a migraine patient experiences at least 15 migraine-induced headache days per month,” said primary investigator Brian Grosberg, MD, director, Hartford Healthcare Headache Program, in a press release.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 2 headache days per week."

The FDA approved Nerivio in October 2020 as the first smartphone-controlled prescribed wearable device for the acute treatment of migraine. Nerivio has since been approved for the acute treatment of episodic and chronic migraine in adult and adolescent patients. At the start of a migraine attack, the REN device, which is worn on the upper arm, triggers an endogenous analgesic mechanism called conditioned pain modulation.

Among 78 patients with chronic migraine, 62.8% of those administered REN experienced significant single-treatment pain relief within 2 hours of initiating treatment compared with 48.7% of patients administered standard care (P = .056). Further, 64.1% of patients in the REN cohort achieved constant pain relief vs 57.7% of patients in the standard-care medications (P = .369) cohort.

Single-treatment pain relief was achieved in 23.1% of patients with chronic migraine given Nerivio compared with 19.2% of patients in the standard medication cohort (P = .532). Further, REN and standard of care medications produced 14.1% consistency of pain freedom across multiple treatments (P = 1.00).

In a dual-arm study published in Pain Medicine, the combination of the Nerivio device with Nerivio’s Guided Imagery, Education and Relaxation (GIER) optional in-app behavioral intervention led to a greater proportion of patients experiencing consistent pain relief and improved symptoms of their acute migraine versus treatment with REN treatment alone.^3,4

The researchers evaluated 85 patients with migraine who were at least 18 years of age and who treated their attacks with REN in parallel with the GIER intervention (REN+GIER) and individually matched them on age and sex with 85 patients who used REN alone. At 2 hours post-treatment, the REN+GIER group displayed statistically significantly higher proportion of patients achieving consistent pain relief (P = .008), consistent improvement in function (P = .014), and consistent return to normal function (P = .005) than the REN-only group.

"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,” Grosberg said in the release. “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

References
1. New study suggests REN comparable to standard care prescribed medications for acute treatment of chronic migraine. News release. Theranica. September 19, 2022. Accessed September 30, 2022. https://www.prnewswire.com/news-releases/new-study-suggests-ren-comparable-to-standard-care-prescribed-medications-for-acute-treatment-of-chronic-migraines-301626947.html
2. Grosberg B, Rabany L, Vizel M, et al. Effectiveness comparison of remote electrical neuromodulation and standard-care medications for acute treatment of chronic migraine: a post-hoc analysis. Pain Manag. 2022;12(7):837-844. doi:10.2217/pmt-2022-0053.
3. Peer-reviewed study shows positive impact of Nerivio’s Guided Imagery, Education, and Relaxation (GIER) feature on migraine treatment response. News release. Theranica. February 16, 2022. Accessed February 18, 2022. https://www.prnewswire.com/news-releases/peer-reviewed-study-shows-positive-impact-of-nerivios-guided-imagery-education-and-relaxation-gier-feature-on-migraine-treatment-response-301483460.html

4. Buse DC, Rabany L, Lin T, Ironi A, Connelly MA, Bickel JL. Combining guided intervention of education and relaxation (GIER) with remote electrical neuromodulation (REN) in the acute treatment of migraine. Pain Med. Published online February 11, 2022. doi:10.1093/pm/pnac021