Yarnitsky D, Dodick DW, Grosberg BM, Burstein R, Ironi A, Harris D, Lin T, Silberstein SD. Remote Electrical Neuromodulation (REN) Relieves Acute Migraine: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial. Headache. 2019 May 9. doi: 10.1111/head.13551. [Epub ahead of print]
To assess the efficacy and safety of a remote electrical neuromodulation (REN) device for the acute treatment of migraine.
There is a significant unmet need for novel effective well-tolerated acute migraine treatments. REN is a novel acute migraine treatment that stimulates upper arm peripheral nerves to induce conditioned pain modulation - an endogenous analgesic mechanism in which conditioning stimulation inhibits pain in remote body regions. A recent pilot study showed that REN can significantly reduce headache. We have conducted a randomized, double-blind, sham-controlled study to further evaluate the efficacy and safety of REN for the acute treatment of migraine.
This was a randomized, double-blind, sham-controlled, multicenter study conducted at 7 sites in the United States and 5 sites in Israel. Two hundred and fifty-two adults meeting the International Classification of Headache Disorders criteria for migraine with 2-8 migraine headaches per month were randomized in a 1:1 ratio to active or sham stimulation. A smartphone-controlled wireless device was applied for 30-45 minutes on the upper arm within 1 hour of attack onset; electrical stimulation was at a perceptible but non-painful intensity level. Migraine pain levels were recorded at baseline, 2, and 48 hours post-treatment. Most bothersome symptoms (MBS) were also recorded. The primary efficacy endpoint was the proportion of participants achieving pain relief at 2 hours post-treatment (improvement from severe or moderate pain to mild or none, or from mild pain to none). Relief of MBS and pain-free at 2 hours were key secondary endpoints.
Active stimulation was more effective than sham stimulation in achieving pain relief (66.7% [66/99] vs 38.8% [40/103]; therapeutic gain of 27.9% [CI95% , 15.6-40.2]; P < .0001), pain-free (37.4% vs 18.4%, P = .003), and MBS relief (46.3% vs 22.2%, P = .0008) at 2 hours post-treatment. The pain relief and pain-free superiority of the active treatment was sustained 48 hours post-treatment. The incidence of device-related adverse events was low and similar between treatment groups (4.8% [6/126] vs 2.4% [3/126], P = .499).
REN provides superior clinically meaningful relief of migraine pain and MBS compared to placebo, offering a safe and effective non-pharmacological alternative for acute migraine treatment.
The US Food and Drug Administration (FDA) has cleared a noninvasive neuromodulation device (Nerivio Migra, Theranica) for the relief of acute migraine pain.
Nerivio Migra is a "first-in-category product," according to the company. It is worn on the upper arm and uses smartphone-controlled electronic pulses to relieve migraine through conditioned pain modulation — an endogenous analgesic mechanism in which conditioning stimulation inhibits pain in remote body regions.
The device is indicated for the acute treatment of migraine with or without aura in adults who do not have chronic migraine.
The FDA cleared Nerivio Migra on the basis of results of a prospective, randomized, double-blind, placebo-controlled study involving 252 patients who experienced two to eight migraines per month...
"The clinical data of this innovative therapeutic device is of very high quality. It indicates that the device can provide patients with significant relief of pain and other migraine symptoms without the side effects presented by drugs," neuroscientist Messoud Ashina, MD, PhD, of the Danish Headache Center, who is president-elect of the International Headache Society, said in a news release from the manufacturer.
"This study followed the latest edition of the guidelines from the International Headache Society for controlled trials of acute treatment of migraine attacks in adults," added Brian Grosberg, MD, director of the Hartford Healthcare Headache Center in Connecticut, who was principal investigator of the study.
"The results of the study demonstrate a high efficacy ratio for single as well as multiple attacks, both at 2 and 48 hours after treatment," said Grosberg.
The company plans to launch Nerivio Migra in the United States later this year "at an affordable price," Alon Ironi, CEO and cofounder of Theranica, said in the release. "We have identified at least 7 different painful conditions that may be relieved by this noninvasive, drug-free technology after appropriate clinical development," he added.