Relivion Neuromodulator Device Wins FDA Approval
The U.S. Food and Drug Administration has approved another neuromodulation device for acute Migraine treatment in adults. The Relivion joins a growing list of devices designed to give drug-free relief to people having Migraine attacks. Let’s take a look at what we know about Relivion and why neuromodulation devices may be important additions to your Migraine toolbox.
Relivion Approved in the U.S.
In February 2021, the FDA approved Relivion, a noninvasive neuromodulation device, for the treatment of acute Migraine in adults. The device is an electronic headband that sits around your head (1)(2).
Neurolief, the Israeli company that developed Relivion, says the device has three channels that deliver stimulation to the trigeminal and occipital nerve branches. You control the device with a smartphone app, which also helps the company fine-tune the stimulation patterns that help you best. It folds up when you’re not using it, taking up about as much room as a pair of sunglasses in a case (3).
The rechargeable device will be pre-loaded with 10 treatments. You will be able to load more over the internet. Relivion will require a prescription from your healthcare provider. Although the device is not yet available, we expect it will be available in the U.S. by late summer 2021(4)(5).
How Effective Is Relivion?
In clinical trials, nearly half the people who tried Relivion reached complete pain freedom after two hours as compared to placebo. Six out of 10 reported significant pain relief after using Relivion. Three out of four were completely free of their most bothersome symptoms (nausea, sensitivity to light and/or sound) associated with Migraine attacks within two hours of treatment. No serious adverse events were reported (6).
How Does Neuromodulation Work?
Relivion is one of three devices that use electrical impulses to stimulate different nerves. Experts believe that these tingly sensations stimulate activity in your brainstem that interrupts the Migraine attack process. Although experts aren’t entirely sure why sending these competing signals to the brain seems to work, neuromodulation does provide a benefit for many people with Migraine, especially people who can’t use acute medications or haven’t had success with them (7).
There are three neuromodulation devices currently available in the United States: Cefaly, gammaCore, and Nerivio. They each target different nerves involved in the Migraine process. The Cefaly device targets the supraorbital branch of the trigeminal nerve, near the eye socket. The gammaCore device is placed at the neck where it targets the vagus nerve, a major nerve involved in many tasks, including heart rate and digestion. The Nerivio device stimulates nerves in the arm to trigger the brainstem into sending “stop the pain” messages down all the nerve channels, including those involved in the Migraine process (8).
Relivion targets two main nerve branches believed to be involved in the Migraine process: the trigeminal nerve branches in the front of the head and the occipital nerve branches in the back of the head. Researchers hope that targeting multiple nerve branches at once will increase the benefit to patients and better relieve their pain (9).
Could Relivion Help With More Than Migraine?
The Relivion device may potentially have benefits beyond treating Migraine attacks. Neurolief is currently testing the device for several other neurological conditions, like depression, insomnia, and ADHD.
Those conditions are comorbid with Migraine disease, which means that if you have one condition, you’re more likely to have one or more of the others. Take depression, for example: The comorbidity doesn’t mean that Migraine disease causes depression (though, of course, having Migraine attacks doesn’t do wonders for anybody’s mood); it means that, for many people, Migraine and depression tend to come in a “combo platter.”(10).
One hypothesis is that Migraine and these other conditions may have some connection on a genetic or biologic level, as though they’re cousins. If Relivion works for Migraine attacks and these other conditions, it might give scientists clues about how these cousins are related and what kinds of treatments they can develop next.
What Does an Expert Say About Relivion?
Dr. Stewart Tepper, a headache specialist at Dartmouth, states, “Patients will now have access to a highly effective, easy to use, noninvasive, and drug-free therapeutic option that will help them regain control of their lives.” Dr. Tepper was the principal investigator on one of the important trials investigating Relivion. He was involved in the device being approved by the FDA (11).
How Do I Get Relivion?
Relivion isn’t available yet in the United States. We will keep you updated on when it does become available and the best way to get it. It will require a prescription from a healthcare provider.
Will Relivion Be Covered by My Insurance?
Because Relivion is not yet available, we do not have information on its cost or whether any insurers will cover it in part or whole. We’ll update you as we learn more.
Insurance coverage for neuromodulation devices is a complex subject. Although they’re not often covered by commercial insurers in the U.S., manufacturers offer a variety of coupon and other assistance programs to patients. People using Medicare and Medicaid are often not eligible for these programs, but should always contact the company directly to see if they can receive financial assistance.
CHAMP (the Coalition of Headache and Migraine Patients) has created a guide to insurance, discount programs, and navigating coverage. This is a great resource when trying to get insurance coverage and/or financial assistance with your prescriptions (12).
Relivion will soon join a growing list of non-drug therapies for acute Migraine treatment. For people who want to add a non-medication option to their Migraine toolbox or can’t use medications safely, a neuromodulation device can be a great option. Relivion may also show scientists more about the connections between Migraine and other comorbid neurological conditions, like depression and insomnia.
Do you use a neuromodulation device to help treat Migraine? Is it effective? Share your thoughts here.
Dr. Stewart Tepper is on the Advisory Board for Neurolief, the company that makes Relivion.