Neuromodulation Devices for Migraine Treatment

Introduction to Neuro-modulation for Migraine Treatment

What is Neuro-modulation?

Although we don’t know the cause of migraine or exactly how it works, we do know that during a migraine attack, certain neural pathways activate and cause our brain to perceive pain. 

Neuro-modulation devices are designed to target the central and peripheral nerves pain pathways that are active during a migraine attack. These devices emit a current, or signal, that safely and effectively stimulates the nerves and actively change the way the brain functions to reduce or stop the perceived pain of an attack. 

Why is Neuro-modulation Important for people with Migraine?

Migraine is the leading cause of disability for people under 50 years old worldwide, impacting quality of life and affecting every aspect of a person’s life: work, home, social and personal.

Neuro-modulation is a non-medicinal treatment option that can be used at home and works differently to medication, which may be encouraging to people living with migraine who feel they have tried everything and nothing has worked. Whilst migraine specific medications such as triptans, gepants or anti-CGRP medications target the proteins identified to be involved in an attack, neuromodulation devices target the pain pathways that activate during the attack. 

Neuromodulation plays an important role in reducing pain in people with different types of migraine (chronic migraine, status migrainosus) as well as other headache disorders such as cluster headache and occipital neuralgia. 

It can offers flexibility and hope for people who have tried more than one medication with little to no improvement and are looking for a more optimal relief option; people who are unable to take some migraine specific medications due to contraindications with other medications or comorbid medical conditions; pregnant women and adolescents (12-17 year olds). 

Non-invasive neuromodulation is a safe and mostly well-tolerated treatment option with few side effects. It can be an effective way to manage migraine, but different devices may work better for some people than others. More research is needed to help doctors choose the best option for each patient. (1, 2).

Types of Neuro-modulation Devices

Overview of Available Devices

There are five types of non invasive neuromodulation devices indicated for either acute or preventative treatment of migraine, sometimes for both. These are: 

• • • Cefaly 
    • gammaCore 
    • eNeura / SAVI Dual
    • Nerivio
    • Relivion

Only two devices are available in Australia at the moment: Cefaly which is available without a prescription, and gammaCore which is available by prescription -only. Medical devices are not usually listed on the Pharmaceutical Benefits Scheme (PBS), so it is unlikely that this status will change. 

Non-invasive vs. Invasive Options

Whilst most options in the market are non-invasive, meaning they are worn or applied superficially, some are implantable and work on the root of the nerves, or deep within the brain. 

The different types of neuromodulation can include:

• • • Transcutaneous electrical nerve stimulation, which stimulates peripheral nerves close to the site of pain, i.e. the head during a migraine attack. This is the type of neuromodulation involved in Cefaly. These devices are non-invasive and user-friendly.
    • Remote electrical neuromodulation, which stimulates a distant part of the body (‘remote from the pain site’), for example, the upper arm, to activate a natural process in the brain to reduce pain in migraine. 
    • Vagus nerve stimulation sends signals to the vagus nerve, which transmits information about the body’s conditions to the brain. Gammacore™ is a noninvasive device available in Australia that uses this type of neuromodulation.
    • Occipital nerve stimulation targets the occipital nerves at the back of the head. These devices are implanted, and usually used for patients with chronic migraine who are not responsive to other treatments.

How Do Neuro-modulation Devices Work?

Mechanisms Behind Neuro-modulation in Migraine Relief

Our brain does not have the ability to feel pain. Instead, the nerves, such as the trigeminal nerve, the vagus nerve, or the occipital nerve, pass the sensation of pain on the brain’s behalf. The trigeminal nerves are the nerves around the head which are responsible for sensations in the face, head and certain motor functions such as chewing. The vagus nerve carries information to and from the heart, lungs and digestive tract, controlling the body’s autonomic, or involuntary, functions such as respiration, digestion, blood pressure, heart rate, among others. The occipital nerves are a group of nerves that supply sensation to the back and side of the scalp and the external ear.

Overview of Pain Pathway Modulation

Neuromodulation devices have small electrodes that are worn or applied on the surface of the skin in certain parts of the body, and work by transmitting electrical or magnetic pulses that target these nerves. This results in a change in brain function, interrupting the pain pathways and processes caused by migraine and headache disorders during an attack. 

Neurostimulation (also referred to as neuromodulation) involves:

1.  Electrical impulse generation. The device generates electrical impulses, but the strength, frequency and duration of those impulses varies depending on patient comfort and the type of treatment.
2. Stimulating specific nerves. The Cefaly device is placed on the forehead to stimulate the trigeminal nerve.
3. Interference with pain signals. The electrical impulses interfere with pain signals to prevent them from being sent to the brain.
4. Neuroplasticity. Over time, regular nerve stimulation could promote neuroplasticity, essentially “retraining” the brain. One study shows that regular preventive treatment has a sedative effect, normalising activity in areas of the brain that are more likely to be overactive in migraine (3).

These nerves can be stimulated in other ways, such as using cold or hot packs, with massage, acupressure, acupuncture, deep breathing, etc.  The advantage of using a neuromodulation device is that they have been specifically designed to target the pain pathways during a migraine attack. It also ensures you are getting a repetitive, consistent dose every time and the same dose over the duration of treatment (4).

Popular Neuro-modulation Devices for Migraine

External Trigeminal Nerve Stimulation (e.g., Cefaly, Relivion)

How Cefaly Works 

The Cefaly device is a transcranial supraorbital stimulation device. It is worn on the forehead, and acts on the supraorbital nerve, a branch of the trigeminal nerve. 

Cefaly is easy to use. First cleanse your skin, then place the electrode on your forehead (and only on your forehead), connect the device, turn on either the acute (60 minutes) or preventive (20 minutes) setting and at the end of the session the device turns itself off automatically. You can read more about how to use Cefaly in this article.

Benefits and limitations

Cefaly is safe to take on your travels, it can go through the x-ray machine and also baggage check. And it is also safe to use during the flight. There is no risk of addiction or overuse, unlike with some medications. There are no interactions with other medications.

The Cefaly can be expensive. Some individuals might not be able to tolerate the electrical sensations.

How Relivion MG Works

Relivion MG is similar to Cefaly in that it targets the trigeminal nerve, but it is also a combined occipital nerve stimulator device.

Relivion has only been approved for acute migraine treatment in adults.

It is an adjustable headband designed to stimulate both the trigeminal and occipital nerves at the same time. It comes with pads to insert for contact with the skin and a smartphone app to control the device and save information about usage.

Benefits and Limitations

Relivion has been shown to be more effective than the sham devices (a device tweaked to emit non-therapeutic impulses similar to the real one)  in alleviating the pain and associated symptoms of a migraine attack in two randomized, sham-controlled clinical studies (5, 6).

Relivion can target all peripheral nerves in the face and head and be useful for generalised and posterior head pain, and not just the supraorbital nerves like with the Cefaly. 

Remote Electrical Neuromodulation (e.g. Nerivio)

How Nerivio Works

Nerivio works through Remote Electrical Neuromodulation (REN), by wearing the device around the upper arm secured with an armband, sending signals through the pain regulation centers in the trigeminal cervical nerve complex which activates conditioned pain modulation, meaning that it engages a natural pain-relieving process in the brainstem. This activation of pain relieving process then disrupts the pain pathways that activate during a migraine attack.

Benefits and Limitations

Nerivio has been approved for both acute (45 minute sessions as needed) and preventive treatment (45 minutes every other day) in adults and adolescents older than 12.

Treatment can be received subtly due its size and location unlike other devices on the head which may attract unwanted attention if used in public. For those who are very sensitive in the face and scalp during a migraine attack, this is better tolerated as it is a site away from the pain site.

Vagus Nerve Stimulation (e.g., gammaCore)

How gammaCore Works

The gammaCore device is a vagal nerve stimulator. gammaCore is clinically proven to treat and prevent migraine attacks in users aged 12 and up. It is also clinically proven to treat and prevent cluster headache and hemicrania continua.

gammaCore is a non-invasive vagus nerve stimulator (nVNS), meaning it does not require surgery. It works by activating the vagus nerve with gentle electrical stimulation through the skin in the neck to block the pain signals and helps provide fast relief and prevent future attacks.

The device is small and easy to use. First find the vagus nerve on your neck, then apply the supplied gel (other gels don’t work) to the stimulation surfaces on the device, and then apply the device to your neck. You know it’s working when you notice slight muscle contractions at the corner of your mouth or you feel a tingling sensation or a downward pull on your lip.

gammaCore is approved for both acute (2x 2 minute sessions at the time of an attack as needed if pain persists) and preventive treatment (2x 2 minute sessions twice a day).

Benefits and Limitations

It is small and portable. Both the device and the liquid gel are safe to take in carry-on baggage when travelling. 

gammaCore is not recommended if you have:

• epilepsy
• significant cholesterol buildup in the arteries of the neck (carotid atherosclerosis) 
• if you ever had a surgery called a “cervical vagotomy”
• vasovagal syncope (a type of fainting disorder).

According to gammaCore, most patients using the device will see a response within 3-5 acute attacks or after 4-8 weeks of preventive therapy (7).

Transcranial Magnetic Stimulation (TMS)

How SAVI Dual or eNeura Works

Transcranial magnetic stimulation works by possibly decreasing a process called cortical spreading depression which is believed to be the mechanism behind migraine with aura. 

The SAVI Dual or eNeura is a non invasive TMS device that works by releasing a single transcranial magnetic stimulation (sTMS) pulse applied in the occipital region at the back of the head. It is simple to use: you turn it on, you hold it to the back of your head, and you turn on the treatment button. 

A typical treatment plan will start with a few sTMS pulses twice daily for prevention and a few pulses as needed for treatment of a migraine attack.

Benefits and Limitations

It is a bigger device than the others previously mentioned. This works directly on the brain on the source of the migraine, unlike the other mentioned neuromodulation devices.

Inhibiting cortical spreading depression potentially has a role in migraine prevention as well as possibly acute treatment for migraine with aura. To date, unfortunately, we don’t have very strong evidence for this yet.

Occipital Nerve Stimulation and Other Options

Other treatment options include more invasive nerve stimulation and nerve blocks.

Implantable Devices (Occipital nerve stimulator)

An occipital nerve stimulator is implanted via surgery at the base of the skull, which connects with wires to a pulse generator that is implanted usually below the clavicle (collarbone).

There are the risks associated with any surgery, as well as risk of infection, pain and muscle spasms, and a possible need to have regular surgical procedures to check on wire placement.

The implanted occipital nerve stimulator is usually an option for people with chronic, intractable migraine who haven’t responded to any other migraine medications.

The efficacy of occipital nerve stimulation implantable devices is not fully determined. Some trials have shown that at 12 weeks, efficacy was no more than the sham devices, however at longer term 52 weeks, the efficacy was better than sham controls (8).

Patients and doctors should weigh the potential benefits and risks relative to invasive neuromodulation devices before deciding on a semi-permanent implantation.

Acute vs. Preventative Use of Neuro-modulation Devices

Acute treatment is an intervention at the time of an attack which helps alleviate pain and associated symptoms. 

Preventive treatment is an intervention administered on a regular basis, outside of an attack, to help change the pain pathways, “retraining” the brain as it were, to help it break the pain cycle.

Clinical Evidence & Effectiveness

In general, neuromodulation has been proven to be very effective, well tolerated, with minimal side effects (1, 2).  

Neurologists recommend allowing at least three months to evaluate the effectiveness of any new treatment. Just as migraine affects each person differently, the effectiveness of neuromodulation devices can also vary from one individual to another.

Since each device operates differently and targets mechanisms distinct from those of migraine-specific medications, even if a medication hasn’t worked for you, it may be worthwhile to try one or more devices to assess their effectiveness.

Key Studies and Research Supporting Neuro-modulation Devices

Cefaly

The Cefaly device has at least one well controlled, well designed study that shows a decrease in headache days in patients with episodic migraine. There is some suggestion that it might be helpful for people with chronic migraine as well, but the evidence is not as strong (9).

The Cefaly device targets the trigeminal nerve because it has been shown to play a role in migraine. The exact mechanism of action is unknown, however multiple studies have shown that transcutaneous neurostimulation (TNS) is effective in treating pain (3). Specifically, a study supports changes in 2 regions of the brain, the rostral anterior cingulate cortex and orbitofrontal cortex after 3 months of use to modulate headache pain (10).

gammaCore

Vagus nerve stimulation has been widely researched and studied. The gammaCore device itself has 7 different FDA (the USA’s Food and Drug Administration) clearances with robust scientific & clinical data to support its safe and effective use, including 7 randomized controlled clinical trials, 30 mechanisms of action peer-reviewed papers, and 40 peer-reviewed clinical papers (11).

Outcomes and Success Rates for Different Devices

Similar to medications, the success rates of these devices vary depending on the individual. However, the general figures provided below offer an overview of what you might expect when using these devices.

Cefaly users reported (9, 12): 

• 33% of acute users reported 50% pain relief after treatment at 1 hour 
• acute users experience an average 59% reduction in migraine severity after treatment at 1 hour
• 29% of acute users experience pain freedom after treatment at 1 hour 
• preventive users with episodic migraine reported 36% reduction of acute migraine medication use per month
• 38% of preventive users with episodic migraine experienced reduced migraine frequency by 50% per month vs 12% with sham device, at three months

gammaCore users reported (13, 14): 

• feeling pain relief in as little as 30 minutes after treatment (12.7% vs 4%)
• almost 30% of episodic migraine users had little to no migraine pain within 2 hours after first use
• 45% of preventive users with episodic and chronic migraine had a 50% treatment response in headache days at twelve weeks (compared to 27% with a sham device).

Safety and Side Effects

Most common side effects

Most neuro-modulation devices for migraine are considered safe with minimal side effects.
Common side effects may include:

• Skin irritation or mild discomfort from the electrodes or patches.
• Sleepiness or drowsiness during the treatment session
• Mild headaches or dizziness after using the device.
• Temporary discomfort from the electrical pulses, especially for those with sensitive skin.

These side effects are typically short-lived and can be managed by adjusting the device settings or ensuring proper skin care before and after use. However, as with any treatment, it’s important to consult with your healthcare provider before starting to ensure that the device is appropriate for you, especially if you have pre-existing conditions.

Contraindications

Nerve stimulation devices may not be suitable for everyone. They are not recommended for individuals:

1. with metallic implants in the head or neck (although each device explains who can use it)
2. with implanted electrical devices such as cardiac pacemakers or implanted hearing aids, and implanted or wearable defibrillators 
3. who are suffering from pain of unknown origin
4. with history of, or increased risk of seizures or strokes. gammaCore is not safe for people with epilepsy. 

As with any medical device, it’s crucial to discuss your medical history and potential risks with your healthcare provider.

Patient Safety Considerations

Unlike medications, neuromodulation devices do not carry a risk of addiction or overdose, making it a preferable option for some. 

People with open wounds, irritated or inflamed skin on the areas where the device is placed are advised not to use the devices. 

Although there are no specific evaluations of these devices in pregnant women, no fetal malformations or birth defects have been observed in animal studies, post-marketing surveillance, or open-label studies (15).

Ideal Candidates for Neuromodulation

It is hard to predict who will respond better to neuromodulation but in general, neuromodulation devices are a worthwhile consideration for:

• People with health issues that contraindicate taking usual migraine drugs
• People who don’t tolerate well the usual migraine drugs
• Pregnant women and adolescents (12-17 year olds)
• People who have tried a few different migraine medications with little to no relief
• People who want to avoid medication overuse headache

Benefits of Neuro-modulation Devices

Non-invasive and Minimal Side Effects

Neuromodulation devices offer a very safe, well tolerated, and effective alternative to pharmaceuticals, with minimal side effects and no negative interactions with other drugs. This opens a treatment avenue to groups not always catered for such as pregnant women and children as well as people with chronic or intractable migraine. 

Reduced Reliance on Medications

For people who have higher frequency of migraine attacks (high frequency episodic or chronic migraine) and who are more reliant on acute treatments (such as NSAIDs), the risk of medication overuse headache becomes higher, as well as increased risk of high blood pressure, heart disease and damage to kidneys (16). As neuromodulation devices are not a pharmaceutical treatment, they don’t interact with other drugs to cause negative reactions and they are not addictive in nature. 

Neuromodulation devices can serve as a first line of defense  during an attack, providing an opportunity to reduce the amount of medication taken each day/week/month. Additionally, neuromodulation devices may be of great help in reducing pain and associated symptoms for people who have nausea or vomiting as a feature of their migraine attacks, or with vestibular migraine, where traditional migraine medications may be affected by gastroparesis (a slow down of the digestive system) which reduces the absorption of oral medications. 

Customizable and Personalized Treatment Plans

In discussion with your doctor, a customizable treatment plan using neuromodulation devices can be created alongside other preventive or acute medications. You may find that neuromodulation devices are helpful as a complementary addition to your migraine management plan, rather than replacing your current treatments. 

Cost, Availability and Accessibility

Cost

Medical devices are not usually listed on the Pharmaceutical Benefits Scheme (PBS), so it is unlikely that this status will change. 

Cefaly

Cefaly is available in Australia without a prescription and it is not listed on the Pharmaceutical Benefits Scheme (PBS). The device and electrodes (which need to be replaced from time to time) can be purchased via their website.

The current device is available for $499 (reduced down from RRP $699), although this offer may be limited. Depending on your private health insurance and level of cover, you may be able to claim up to 80% off the purchase price. If you are on the NDIS, you can ask your case manager if you are eligible to get Cefaly for free.

The electrodes come in packs of three and cost $60 per pack ($65 for the blue gel electrodes), or $45 if you subscribe for recurring orders. The electrodes need to be replaced when the adhesive no longer sticks well to your skin. The number of uses will vary depending on how you care for them, and whether you buy standard or hypoallergenic electrodes (standard typically lasts longer).

gammaCore

In Australia, gammaCore can be used for the treatment and/or prevention of primary headache (migraine, cluster headache, and hemicrania continua) and medication overuse headache in adults. gammaCore is available in Australia on authorisation by a registered healthcare professional. 

gammaCore is rechargeable and requires a gammaCore refill card to load the device with days of therapy. Each ‘dose’ consists of stimulation of about 2 minutes after which the device automatically turns off. In each 24 hour period, you have access to 30 gammaCore stimulations. The daily countdown will occur regardless of use. Consult your healthcare professional about the cost.

Availability and Accessibility

Conclusion

The field of neuromodulation devices has been developed a lot in recent years, providing a non-medicinal treatment option that offers hope and relief to patient groups who were historically not catered for, e.g: people with chronic migraine or high frequency episodic migraine, people with low tolerability to migraine medications or contraindications due to other health issues, pregnant people and adolescents (aged 12-17). 

These devices are very effective and easy to use, can be used from the comfort of your own home, have low side effects and are well tolerated, they are not addictive, however they can be expensive. 

People who have implanted metal devices, implanted electrical devices, or are at increased risk for seizures or strokes should not try neuromodulation devices.

 Just like other migraine medications and treatments, neuromodulation devices are not a cure. It is important to consider neuromodulation in the context of your overall migraine management strategy which may include other such as:

• Getting consistent, sufficient, and restorative sleep
• Managing stress
• Managing triggers (i.e. fluorescent lights, bad posture, foods, etc)

Sleep disruptions, high or volatile stress levels and other factors can still trigger migraine attacks even if you are using neuromodulation or another treatment. On the other hand, if you are managing these factors and using neuromodulation devices as directed, it could potentially make a bigger difference in your migraine condition.

Further information & resources

Neuromodulation devices present a promising non-drug alternative for managing migraine. Their safety, efficacy, and non-addictive nature makes them a worthwhile consideration. However, individual experiences and results may vary, making it important to discuss these options with a healthcare provider.

Additional links to learn more about Cefaly, gammaCore, migraine, or other treatment options, you can check out the following resources:

• Cefaly Australia – official Cefaly website.
• gammaCore – official gammaCore website.
• eNeura.com – official eNeura website.
• Nerivio  – official Nerivio website.
• Relivion – official Relivion website.
• Migraine – a comprehensive article about migraine symptoms, causes, treatments, and more.
• Treatment Options – migraine treatment options including treatment directory. 
• Acute treatments – article about different types of acute treatments
• Preventive strategies & treatments 2021 – this article discusses other preventive medications & management strategies for migraine. 
• Cefaly FAQs – from Cefaly website
• gammaCore FAQs – from gammaCore website  – in Australia supplied by Medistar.
• eNeura FAQs – from eNeura website.
• Nerivio FAQs – from Nerivio website
• Relivion FAQs – from Relivion website.

References 

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11. gammaCore: “Exploring gammaCore™: How gammaCore works”. Accessed 2025 from: https://www.gammacore.com/about-gammacore/how-gammacore-works/.
    
12. Chou DE, et al. Acute migraine therapy with external trigeminal neurostimulation (ACME): A randomized controlled trial. Cephalalgia. 2019;39(1):3-14. doi: 10.1177/0333102418807269.
    
13. Tassorelli et al. Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study. Neurology 2018 doi: 10.1212/WNL.0000000000005857. 
    
14. Najib et al. Non-invasive vagus nerve stimulation for prevention of migraine: the multicenter, randomized, double blind, sham controlled PREMIUM II trial. Cephalalgia 2022  doi: 10.1177/03331024211068813.
    
    
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16. Ailani J.: “Controlling chronic migraine”. Migraine World Summit, 2024. Accessed 2025 from: https://migraineworldsummit.com/talk/controlling-chronic-migraine/