The approval was based on a clinical trial published online in May 2019 in the journal Headache, in which 2 out of 3 people experienced pain relief within two hours of using the device. The Nerivio Migra was developed by Theranica, a biomedical technology company that specializes in neuromodulation technology. “The data, at least in this clinical study, indicates that this device might be equivalent to the triptan pain relief that we see, although it’s hard to compare because they haven’t been tested in head-to-head trials,” says MaryAnn Mays, MD, a neurologist specializing in headaches and migraine at the Cleveland Clinic in Ohio, who was not involved in the research or development of Nerivio Migra. “It looks pretty promising,” she adds.
Migraine: A Lifelong Disorder and Quality-of-Life Concern
Migraines have a big impact on the overall quality of a person’s life, says Dr. Mays. “Migraine limits a person’s ability to participate in work and at home. Those people miss out on a lot of family activities,” says Mays. “Beyond the pain of migraines, many people also live in fear of when the next migraine is coming,” she says. For most people with migraines, it’s a lifelong disorder that is always present, says Mays. Migraines affect approximately 1 in 6 people in the United States, and 1 in 5 women over a three-month period, according to a review published in April 2018 in the journal Headache. Migraine is the sixth highest cause of years lost to disability, and headache disorders collectively were the third highest, according to the Global Burden of Disease Study, published in November 2018 in the journal The Lancet Neurology.
2 out of 3 People Experienced Pain Relief With New Device
FDA approval was based on the results of a randomized, double-blind, sham-controlled multicenter study conducted at 12 sites: seven in the United States and five in Israel. The 252 participants met the International Classification of Headache Disorders criteria for migraine, with two to eight migraine headaches per month. Active and sham stimulation were applied in a 1:1 ratio. Sham control is similar to placebo control in pharmaceutical trials; in this case, the sham was a faked stimulation that had no therapeutic value. Within one hour of migraine attack onset, the Nerivio Migra device was applied on the subject’s upper arm for 30 to 45 minutes. The impulses from the stimulation can be felt, but they aren’t painful, according to the study authors. Migraine pain levels were recorded at the onset of therapy, or baseline, at two hours, and at 48 hours after treatment. The primary endpoint of the study was the percentage of people who achieved pain relief at two hours post-treatment, which included improvement from severe to moderate pain to mild or none, or from mild pain to none. Relief from most bothersome symptoms (MBS) and pain-free at two hours were secondary endpoints. The Nerivio Migra was more effective than sham stimulations in all categories:
66.7 percent of people (66 out 99) treated with Nerivio Migra achieved pain relief versus 38.8 people getting the sham treatment.More than twice as many people were pain-free with Nerivio Migra compared with sham, 37.4 percent compared with 18.4 percent.Active stimulation was superior in relief of MBS compared with sham treatment (46.3 percent vs. 22.2 percent).Pain relief and pain-free superiority of active treatment over sham treatment was sustained 48 hours post-treatment.
Device-related adverse events were similar — 4.8 percent for active treatment compared with 2.4 percent for sham treatment.
Electroceutical Options for Headache and Migraine Treatment Growing
There are three other similar nerve stimulation devices that have received FDA approval for migraine with different specific indications, says Mays:
STMS, or single-pulse transcranial magnetic stimulation, is indicated for acute and prophylactic migraine in people ages 12 and older.GammaCore is a handheld device that activates the vagus nerve with gentle electrical stimulation when held against the neck. It’s indicated for the acute treatment of pain associated with migraine and cluster headache in adults and for adjunct use in preventing cluster headache in adults.Cefaly is a nerve stimulation device worn on the forehead. It’s indicated for the prophylactic treatment of episodic migraines and acute migraine treatment in adults.
These devices, including the Nerivio Migra, are all neuro-modulatory and use magnetic or electrical stimulation to promote the neuroinhibitory processes in the brain to turn off pain, says Mays. “The Nerivio Migra uses light painful stimulation. It’s not intolerable pain, but it sends a pain signal up to the brain where it’s perceived,” says Mays. That signal leads to turning on the area of the brain that inhibits pain, she says. “By doing that, you’re turning off pain in another area,” says Mays. The idea to try to use neuro-modulation came from studying the internal system of pain inhibition that every person has, says David Yarnitsky, MD, director of the department of neurology at Rambam Health Care Campus in Northern Israel and lead author of the research. “This system can be activated by various stimuli, including the stimulus given by the device, and works remotely. You give a stimulus at one site, and it can affect a distant pain site,” says Dr. Yarnitsky. Since migraineurs often have less efficient internal ability to inhibit pain, it makes sense to try and augment this ability with the device, says Yarnitsky.
Devices Can Be a New Option or an Adjunct
According to a news release from Theranica published May 28, 2019, in PR Newswire, Nerivio Migra will be launched in the United States later this year at an affordable price. The device could be a viable option for the treatment of migraine, says Mays. “Because migraine is a lifelong disorder, people sometimes worry about the long-term effects of taking a medication for 10, 20, or even 30 years,” she says. Triptans, a class of drugs used to treat migraines, are very effective in the majority of people, but there are some people who don’t get relief from them, says Mays. “Triptans can also be contraindicated because of an underlying history of heart disease or stroke,” says Mays. The device can be used as monotherapy or in addition to other migraine medication, including triptans, says Yarnitsky. Another plus for the devices is the side effect profile, which is going to be mild compared with some of the other medication used to treat migraine, says Mays. “The one problem is that insurance companies haven’t really been very helpful to cover the costs of these devices,” says Mays. It can be high, though in some cases comparable to medication, she says. Another obstacle is patient perception, says Mays. “Because these devices are new, I’m not sure if people buy into their efficacy in the same way as with taking a pill. I think it’s going to take some learning and trial for patients to buy into this,” she says.
