Non-medicated, wearable medical devices for treating migraines are gaining immense popularity, especially among people tired of dealing with the side effects of traditional drugs and other medical treatments. As of now, there are four innovative devices used to treat migraines, all that use different techniques to offer relief.
While all of them are FDA-cleared to be used by adults above 18, only Nerivio, a non-invasive wearable device that uses electronic impulses to provide relief, has been studied or researched enough to have sufficient evidence to back its efficacy. While gammaCore claims the fastest relief, Cefaly is the only one that is available Over The Counter (OTC) and can be used to treat and prevent migraines.
Am I a Good Fit?
If you’re looking for a way to manage your migraines without medication and the associated side effects, consumer medical devices could be a great solution. However, it’s important to bear in mind that these devices can be quite pricey, and not all insurance plans cover them. Moreover, it’s crucial to work with your healthcare provider to determine which device would be most effective for your particular type of migraine and medical history.
Here’s a quick look into the devices:
| Device | Nerivio | Cefaly | Relivion MG | gammaCore |
|---|---|---|---|---|
| FDA Approval | Yes | Yes | Yes | Yes |
| Age | 18 | 18 | 18 | 18 |
| Technology Type | Remote Electrical Neuromodulation (REN) | External Trigeminal Nerve Stimulation (e-TNS) | Neuromodulation Therapy | Non-invasive vagus nerve stimulation (nVNS) |
| Treatment Indication | Acute | Acute + preventive | Acute | Acute |
| Treatment Duration | 45 Min. | 20 Min. | 60 Min. | 2 Min. |
| Placement | Upper Arm | Forehead | Forehead | Neck |
| App | Yes | Yes | Yes | Yes |
| Side Effects | Skin irritation or discomfort at the site of placement, tingling /numbness in the arm, dizziness, & local warmth sensation. | Drowsiness or skin irritation at the area of application | Scalp numbness, skin irritation, Drowsiness during treatment. | Skin irritation, tingling, & dizziness. |
| Ineligible Candidates | Pregnant women, patients with metallic or conductive implants, pacemakers, or with a history of seizures. | Patients above 65, or with a history of seizures, heart conditions, brain injuries, and unusual headaches. | Patients with pacemakers or metal plates/implants in their head, or with a 3-month history of brain/head injury or open cuts on the forehead/back of the head. | Patients with a metal plate/screw in the neck, implanted electrical devices like pacemakers or hearing aids, or on wet skin and open cuts on the neck. |
| Battery Life | 9 hours (dispose and replace) | 1 year | – | 2 years |
| Cost | $10 (Patient’s saving program) | $379 | – | $450 |
The Pounding Battle Against Migraines (Literally)
A migraine is much more than a headache. It’s more of a throbbing headache that feels like a sledgehammer to your brain.
And if that isn’t enough pain, migraines are often accompanied by nausea, vomiting, and piercing sensitivity to light and sound. If this is something you’ve experienced, you’re one of the millions of people globally who suffer from migraines.
According to the World Health Organization, migraines are the third most prevalent illness globally, affecting about 14.7% of the population. In the United States alone, it’s estimated that over 39 million people experience migraines.
Fun Fact: Did you know that the word “migraine” comes from the Greek word “hemicrania,” which means “half the head“? This explains why migraines typically affect one side of the head.
The truth is – there are multiple types of migraines, including migraine with aura, migraine without aura, chronic migraine, vestibular migraine, and menstrual migraine, among others. The treatment approach depends on the type of migraine and its frequency and severity.
While medications do work, they can have side effects that can be unpleasant or even intolerable. For example, some migraine medications can cause fatigue, dizziness, dry mouth, and cognitive impairment. Some medications can also cause rebound headaches – with an ongoing migraine, we don’t even want to imagine how that would feel.
Lasting for hours, or sometimes, even days, migraines cannot be ignored. They interfere with one’s daily life, be it work or social. While some may experience migraines occasionally, others may suffer from them several times a month. In cases like these, it can often become a challenge to manage symptoms, especially with medications alone.
Luckily for us, we live in a world that has been conquered by technology. If you suffer from migraines, you no longer have to just rely on medications. There are medical devices available that can treat migraines, perhaps even more efficiently than medications.
We’ll highlight 4 medical devices used to treat migraines, how they work, and whether they’ll work for you. Don’t worry, we’ll even get into the costing details and whether insurance can cover these devices for you.
Medical Devices that Can Help Take the Migraine Misery Away
Before we dive in, you should know that there are many different types of treatments you can receive for migraines, but we’ll dive into two. You could either receive an acute treatment, a preventative one, or both.
Acute treatments are effective in helping treat the migraine when it’s currently occurring. Preventative treatments, on the other hand, help reduce the number of migraines one experiences. In our discussion of medical devices, we’ll also explore their efficacy as acute and preventative treatment options.
1. Nerivio
Nerivio is a wearable device that uses a technology known as remote electrical neuromodulation (REN) to treat migraines. The device delivers electronic pulses through the skin and into the underlying nerves, which can help to disrupt the pain signals that are associated with migraines. The stimulation is thought to activate the body’s pain relief mechanisms and can also help to reduce inflammation and improve blood flow to the brain.
The device is FDA-approved for adults over the age of 18. Studies have shown that Nerivio reduced acute migraine pain, associated symptoms, and the need for medication in about 50% or more of the adults and adolescents aged 12 and older who experienced episodic, chronic, and/or menstrual migraines – proving that it is a safe and effective treatment option.
Nerivio is meant to be used at the first sign of a migraine attack. Worn on the upper arm and controlled by a smartphone app, one of the device’s advantages is its small size, allowing the user to go about their daily activities, automatically stopping once the 45-minute-long treatment is complete.
Research has shown that REN, the technology used in Nerivio, has the potential to be a favorable and effective alternative to migraine medication. (Rapoport et al. 2019)
A study conducted in 2021 deduced that REN “may have a higher efficacy” in offering relief to migraines than standard care in adolescents – providing a safe, nonpharmacological alternative to its participants. (Hershey et al. 2021)
It is also reported to be effective and well-tolerated for the treatment of menstrual migraine. (Nierenburg et al. 2021)
Here’s how it works:
While Nerivio is generally well-tolerated and has a low risk of side effects, some mild to moderate side effects that can occur include:
- Skin irritation or discomfort at the site of placement
- Tingling or numbness in the arm
- Dizziness
- Local warmth sensation (rare)
Who Nerivio is not for:
- People with implanted electronic devices, such as a pacemaker
- People with metallic or conductive implants in the arm or shoulder
- People with a history of epilepsy or seizures
- Pregnant women
2. Cefaly
Another wearable device, Cefaly is designed to be worn on the forehead and uses electrotherapy to send low-frequency electrical impulses to the trigeminal nerve, which can help to reduce the frequency and severity of migraine attacks. It is designed to be used for 20 minutes per day, either as a preventive measure or as an acute treatment when a migraine attack occurs.
The Cefaly device has been approved by the U.S. Food and Drug Administration (FDA) for the prevention of migraines in adults over 18, and it is also approved for use in Europe and Canada.
The device is generally safe and well-tolerated, with only 1% of the users reporting side effects, including drowsiness or skin irritation at the area of application. So, if this is a device you opt for, make sure you’re not using it while driving or during any activity that requires focus.
Some people have reported experiencing headaches after using Cefaly as a preventative treatment for migraines. If you experience any bothersome side effects, it’s essential to contact your healthcare provider right away.
However, the evidence from existing scientific literature is at risk of bias and is, therefore, insufficient to determine the efficiency of Cefaly, or how it compares with other electrical stimulation devices.
Who Cefaly is not for:
- People over 65
- Women who are pregnant or trying to become pregnant
- People with heart conditions
- People with a history of seizures
- People who have experienced a recent head injury
- Treating sudden headaches that are unusual
3. Relivion MG
Designed to be worn as a headband, the Relivion MG is a handy wearable device for migraine treatment. It uses a combination of nerve stimulation and brain wave modulation to reduce the frequency and intensity of migraine attacks.
As with most technological devices, the Relivion MG has a smartphone app that collects and tracks information related to the user’s migraine symptoms and treatments.
Common side effects include:
- Scalp numbness
- Skin irritation
- Sleepiness during the treatment
Who Relivion MG is not for:
- People with metal plates or implants in their head
- Those who have suffered a brain or head injury within the last 3 months
- People with open cuts on their forehead or the back of the head, as the device will irritate it
- People with implanted electronic devices, such as a pacemaker
Relivion MG is FDA-cleared to treat migraines in adults over 18 years old.
4. gammaCore
A non-invasive device, the gammaCore, is a handheld device that is placed on the neck over the vagus nerve to treat migraines and cluster headaches, which are felt on one side of the head, often around the eye area.
When activated, it delivers a mild electrical signal that stimulates the nerve, which is believed to help reduce inflammation and pain associated with migraines and cluster headaches.
Here’s what a specialist, Dr. Sara Sacco, has to say about the device:
gammaCore has been cleared by the U.S. FDA for the acute treatment of episodic cluster headaches and migraine pain in adults over the age of 18. The device is well-tolerated with side effects including:
- Skin irritation
- Dizziness
- Skin tingling
Who gammaCore is not for:
- People with implanted electrical devices such as a pacemaker or a hearing aid
- People with wet skin or open cuts on their neck, since that is where the device is placed
- People with a metal plate or screw implanted in the neck
Is it possible to treat migraines using consumer medical devices instead of medication?
Yes, you can use consumer medical devices for migraine treatment either alongside medication or on its own. However, it’s important to follow your healthcare provider’s guidance and not stop taking your medication unless advised to do so.
Abruptly discontinuing medication without proper medical supervision could lead to a worsening of symptoms, so it’s essential to consult with your healthcare provider before making any changes to your treatment plan.
How to pick the right consumer medical device for your migraine treatment?
To pick the right device, it’s crucial to know what type of migraines you have and whether you’re looking for preventive or acute treatment. These devices are FDA-cleared for different types of migraines and are used in various ways.
It’s also important to keep your healthcare provider in the loop so that they can recommend the most suitable device based on factors such as the severity of your migraines, medications you’ve tried, and any underlying medical conditions.
Remember, even if a migraine treatment device is available over-the-counter (OTC), it’s still essential to talk to your healthcare provider to determine if it’s right for you.
So, what’s the cost like?
While the cost for each device varies, one thing we can say for sure: they can be expensive. What will really help you make the decision is comparing the cost of your current migraine treatments to the device you’re interested in.
Bear in mind that the cost shouldn’t simply include the monetary cost, but other factors such as how efficient the other treatment is. Will the device offer quicker relief? Will it offer a better preventative treatment? Does the medication mean you have to pause your daily activities while receiving the treatment?
Here’s some information on the cost of these devices:
- Cefaly is the only device that is available over the counter. However, we still recommend you consult with your healthcare provider. On its website, it costs about $379. The electrodes come separately, with a pack of 3 costing about $25. There are also payment plans that can reduce the upfront cost of the device.
- Nerivio, which is prescription-only, can be bought using a patient savings program that can lower the cost to $10 for your first Nerivio device. Each device provides 12 treatments.
- gammaCore is also prescription-only and is offered through a telehealth program on the website, which provides a 3-month device for $450. The website also offers a co-pay assistance program for people with commercial insurance, taking up to 100$ a month off of your co-pay.
- Relivion MG, also a prescription-only device, is relatively new so the retail cost hasn’t been announced yet. It was FDA-cleared in early 2021.
Does health insurance cover Cefaly, Relivion, gammaCore, or Nerivio?
Currently, health insurance doesn’t cover Cefaly and Relivion MG. However, you can pay for Cefaly using a health savings account (HSA) or flexible spending account (FSA). As for Relivion MG, pricing information is not yet available, so it’s unclear if insurance coverage will be offered.
On the other hand, Nerivio is covered by some insurance plans, including the Department of Veterans Affairs (VA). To know if Nerivio is covered by your insurance, it’s best to reach out to your provider.
gammaCore is also covered by some insurance plans, and their manufacturer collaborates with a specialty pharmacy to check for insurance coverage. They offer financial assistance through their gammaCARE program to help individuals who need it.
Are there any new consumer medical devices being developed for migraine treatment?
Researchers are currently exploring alternative migraine treatments that don’t involve medication, and many of these treatments may involve nerve stimulation in some way, like the devices we’ve discussed. However, these new treatments may work differently and involve new types of wearable devices or even implants that go under the skin.
Frequently Asked Questions
What is the wearable device for migraines?
The Nerivio device is worn on the upper arm and managed by a smartphone app for a 45-minute therapy. During a treatment, Nerivio uses Remote Electrical Neuromodulation (REN) to stimulate nerves in the upper arm—nerves that convey pain signals to the brain.
What is the new technology for migraines?
Vagus Nerve Stimulation
The device is placed over the nerve on the side of the neck by the user. A research published in the journal Neurologist in July 2020 discovered that VNS gave pain relief within two hours of the start of a migraine episode, with around 30% of users totally pain-free by that time.
Is Cefaly the same as a TENS unit?
The Cefaly is classified as a transcutaneous electrical nerve stimulation (TENS) unit by the FDA, however it is actually an external trigeminal nerve stimulation (eTNS) unit. The Cefaly’s idea is similar to other neurostimulators being explored for migraine treatment.
How expensive is Nerivio?
The list price (Wholesale Acquisition Price, or WAC) for a 12-treatment unit from Nerivio is $599. Theranica is able to give qualified patients with health insurance a co-pay as low as $10, depending on specific plan coverage, thanks to the Nerivio Patient Savings Programme and reimbursement hub deployment.
What migraine device is approved by the FDA?
Theranica’s Nerivio, a remote electrical neuromodulation (REN) device, was recently approved by the FDA as a dual-use acute and preventative treatment for migraine with or without aura in patients aged 12 and up.
What’s the verdict?
As of now, only Nerivio is the device that is not only FDA-cleared but has enough evidence to consider it to be a safe, effective treatment for migraines. While the other 3 devices are FDA-cleared, there still seems to be a lack of evidence or research backing the efficacy, compared to the research available for Nerivio.
However, non-medical migraine treatments do seem to be getting attention, as they can be an appealing option for people who experience migraines very frequently and don’t seem to get the desired results from medications, especially if they have to struggle with the side effects.
Even as you read this, there’s ongoing research exploring other non-medication treatments for migraines – but that’s no surprise, because when do technological advancements ever take a break, really?
Having said that, it cannot be highlighted enough how important it is to talk to your healthcare provider to see which device will work best for you, and whether it is even the best option. The available devices all work differently, and your healthcare provider will be able to give the most informed decision.
References
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- Rapoport, AM, Bonner, JH, Lin, T, Harris, D, Gruper, Y, Ironi, A, and Cowan, RP. Remote electrical neuromodulation (REN) in the acute treatment of migraine: a comparison with usual care and acute migraine medications. J Headache Pain. 2019;20(1):83.
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