REN may offer a novel alternative for current pharmacological and non-pharmacological treatments in chronic migraine that combines efficient treatment with minimal adverse effects.
Results from an open-label, single-arm, dual-center study (NCT04161807) suggest that the use of remote electrical neuromodulation (REN) through Theranica’s Nerivio device can be an effective and well-tolerated treatment for those with chronic migraine.1,2
Among the 38 participants who were evaluable for analysis, 28 (73.7%) achieved pain relief at 2 hours and 10 (26.3%) were pain-free at 2 hours. Additionally, 27 of 32 individuals (84.4%) had sustained pain relief response at 24 hours and 9 of 20 individuals (45%) had sustained pain relief response at 24 hours in ≥50% of their treated attacks.
For the associated symptoms, 58.3% (14 of 24; 95% CI, 38.6—78.1), 35.5% (11 of 31; 95% CI, 20.8–59.2), and 40% (10 of 25; 95% CI, 20.8–59.2) of patients experienced disappearance of nausea and/or vomiting, disappearance of photophobia, and disappearance of phonophobia at 2 hours in at least 50% of their treated attacks, respectively.
Conducted by Hida Nierenburg, MD, director of headache, Nuvance Health, and colleagues, an improvement in function and return to normal function at 2 hours in ≥50% of attacks was observed in 45.7% (16 of 35; 95% CI, 29.2—62.2) and 28.6% (10 of 35; 95% CI, 13.6–43.5) of patients, respectively.
Patients within the study underwent a 4-week treatment phase during which they treated their headaches with Nerivio for 45 minutes within 1 hour of attack onset. Nierenburg and colleagues recorded pain levels at baseline, 2 hours, and 24 hours post-treatment.
"We were particularly happy with the consistent results for the study participants across multiple treatments. Consistent efficacy is key for patients to have confidence in their therapy and maintaining quality of life. Patients need to know that if the treatment works for them, they can rely on it and won't have to look elsewhere in a month,” Alon Ironi, chief executive officer, Theranica, said in a statement.
Safety analyses were performed on all 42 participants who used the device at least once and showed that at least 1 adverse event (AE) occurred in 4.7% (2of 42; 95% CI, 0.6—16.2) of patients. In total, 1 patient (1.8%) reported having bilateral tingling in the temples, and disturbed and double vision, the only device-related AE in the study.
The study authors concluded that REM may offer a safe and efficacious pharmacological alternative for acute treatment in patients with chronic migraine. “The meaningful clinical benefits and the favorable safety profile introduce an alternative acute therapy that can be incorporated into usual care even in a highly disabled population and may thus reduce medication use, which may in turn reduce the risk for medication overuse headache,” Nierenburg et al wrote..
The Nerivio is a wireless, wearable, non-invasive stimulation device applied to the lateral upper arm between the bellies of the lateral deltoid and the triceps for 45 minutes. It stimulates small skins nerves using a pulse and is controlled by an app that includes a migraine diary to track treatment sessions and migraine headaches.
In early April, Theranica announced that Nerivio will be available in the United States through UpScript’s direct-to-patient telemedicine platform. The device was previously granted de novo clearance by the FDA in May 2019 for the acute treatment of migraine with or without aura in adults who do not have chronic migraine. Notably, it gained national recognition in November 2019 after it was named to TIME Magazine’s annual list of top 100 best inventions.3
1. Theranica reports positive study results of Nerivio for chronic migraine patients [news release]. Montclair, NJ: Theranica. Published July 15, 2020. Accessed July 17, 2020. prnewswire.com/news-releases/theranica-reports-positive-study-results-of-nerivio-for-chronic-migraine-patients-301094164.html
2. Nierenburg H, Vieira JR, Lev N, at al. Remote electrical neuromodulation for the acute treatment of migraine in patients with chronic migraine: an open-label pilot study. Pain Ther. Published online July 9, 2020. doi: 10.1007/s40122-020-00185-1
3. Theranica expands access to prescribed migraine wearable Nerivio through partnership with UpScript health telemedicine platform [news release]. Scottsdale, AZ. April 6, 2020. Accessed July 17, 2020. prnewswire.com/news-releases/theranica-expands-access-to-prescribed-migraine-wearable-nerivio-through-partnership-with-upscript-health-telemedicine-platform-301035804.html