What is Cefaly?
Cefaly is a type of nerve stimulation device that can be used for both acute and preventive migraine treatment. It is an external trigeminal nerve stimulation (e-TNS) device that is worn on the forehead and stimulates the trigeminal nerve, which plays a significant role in migraine attacks.
Migraine is a neurological disorder that can be debilitating. It causes many symptoms including head pain, nausea, light/sound sensitivity, visual disturbances, and more.
Cefaly and other nerve stimulation devices are a good potential treatment option for people who are looking for non-pharmaceutical treatments.
Cost and access in Australia
Cefaly is available in Australia without a prescription and it is not listed on the Pharmaceutical Benefits Scheme (PBS). Medical devices are not usually listed on the PBS, so it is unlikely that this status will change. 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 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 $50 per pack, 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).
How does the Cefaly device work?
Cefaly works based on the principle of neurostimulation, which involves manipulating nerve activity to alleviate migraine symptoms. Neurostimulation (also referred to as neuromodulation) involves:
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- 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.
- Stimulating specific nerves. The Cefaly device is placed on the forehead to stimulate the trigeminal nerve.
- Interference with pain signals. The electrical impulses interfere with pain signals to prevent them from being sent to the brain.
- 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 (1).
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 (1). 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 (2).
About neuromodulation
Cefaly uses external trigeminal nerve stimulation, but there are other neuromodulation formats. The different types of neuromodulation can include:
- Transcutaneous electrical nerve stimulation, which stimulates peripheral nerves. This is the type of neuromodulation involved in Cefaly. These devices are non-invasive and user-friendly.
- Occipital nerve stimulation targets the occipital nerves at the back of the head. These devices are usually used for patients with chronic migraine who are not responsive to other treatments.
- Vagus nerve stimulation sends signals to the vagus nerve, which transmits information about the body’s conditions to the brain. Gammacore™ is one device available in Australia that uses this type of neuromodulation.
While these types of devices are different, they still use the same broad principles of neurostimulation outlined in the previous section.
How to use Cefaly
The futuristic design of Cefaly might seem intimidating, but the device is quite simple to use. It is however quite different to traditional migraine medications – for example, there isn’t a ‘dosage’ in the same way as pharmaceutical medications.
Instead, there is an acute treatment setting and a preventive treatment setting. The acute treatment lasts for 60 minutes and uses high frequency pulses, while the preventive setting is a 20 minute daily session with low frequency pulses. You can choose the intensity of the electrical impulses depending on what feels right for you. Neurostimulation should not be painful, and lower intensity impulses are still effective.
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- Cleanse your skin. It’s important to cleanse your skin before every treatment session, to ensure the electrode attaches securely to your forehead. Use soap and water to cleanse – makeup removing solutions or wipes are not recommended as they can leave residue on the skin. Be sure to dry your skin thoroughly after cleansing.
- Attaching the electrode. Use a mirror to place the electrode so that the curved area is in between your eyebrows, and the wings are just above your eyebrows. Firmly run your fingers over the electrode a few times until it lays flat against your skin.
- Connect your device. On the back of your Cefaly device, you will find two small magnetic contacts which securely attach to the electrode. Hold your device so these magnets are exposed and bring it towards your forehead. You’ll feel the device pulling itself towards the electrode.
- Starting your treatment session. Once your device is securely attached, simply select the acute or preventive setting to begin your treatment.
- At the end of treatment. The device will turn itself off when the treatment is finished.
Even though neurostimulation devices are not pharmaceutical medications, it is just as important to follow your healthcare provider’s advice regarding how and when to use the device.
Safety and tolerability
Nerve stimulation devices are generally considered safe with minimal side effects. Most users report only mild discomfort, such as a tingling sensation where the device is applied (3,4). The second most common side effect is that it can cause sleepiness during the treatment session (1,3). Unlike medications, Cefaly does not carry a risk of addiction or overdose, making it a preferable option for some.
However, nerve stimulation devices may not be suitable for everyone. They are not recommended for individuals who:
- Have implanted metallic or electronic devices in the head,
- Are suffering from pain of unknown origin, or
- Have a cardiac pacemaker or an implanted or wearable defibrillator.
As with any medical device, it’s crucial to discuss your medical history and potential risks with your healthcare provider.
Efficacy
Various studies have demonstrated the effectiveness of nerve stimulation devices in managing migraine. They have shown promising results in reducing the frequency, duration, and severity of migraine. Some patients may experience immediate relief, while others may see benefits after a few weeks of consistent use.
Below are the results of two randomised controlled trials investigating the efficacy of Cefaly for acute and preventive treatment.
Cefaly for acute treatment (5)
| Cefaly (n = 52) | Placebo (n = 54) |
| Reduction in pain after 1 hour (based on patients rating their pain from 0-10) | -3.46 | -1.78 |
| Patients not having used rescue medications within 24h | 51.9% | 55.6% |
Cefaly for preventive treatment (6)
| Cefaly (n = 34) | Placebo (n = 33) |
| Average migraine days per month at baseline | 6.94 | 6.54 |
| Average migraine days per month after three months of treatment | 4.88 | 6.22 |
| Average reduction in migraine days | -2.06 | -0.32 |
| Percentage of patients with 50% or more reduction in migraine days | 38.24% | 12.12% |
Keep in mind that everyone’s experience with migraine medication, management and treatment will vary from person to person. While Cefaly can be very effective for some people, this treatment might not work for everyone, nor is it a cure.
How Cefaly can complement other treatment & management strategies
Just like other migraine medications and treatments, Cefaly is not a cure. It is important to continue other management strategies such as:
- Getting enough sleep
- Managing stress
- Avoiding triggers (i.e. fluorescent lights, bad posture, foods, etc)
Lack of sleep, chronic stress and triggers can still cause migraine attacks even if you are using Cefaly or another treatment. On the other hand, if you are managing these factors and using Cefaly as directed, it could potentially make a big difference for your migraine condition.
You can also use Cefaly alongside other preventive or acute medications. Because Cefaly is not a pharmaceutical treatment, it won’t interact with other drugs to cause negative reactions. You may find that neuromodulation devices are helpful as a complementary addition to your migraine management plan, rather than replacing your current treatments.
Further information & resources
The Cefaly device presents a promising non-drug alternative for managing migraine. Its safety, efficacy, and non-addictive nature makes it a worthwhile consideration. However, individual experiences and results may vary, making it important to discuss these options with a healthcare provider.
If you would like to learn more about Cefaly, migraine, or other treatment options, you can check out the following resources:
