Devices: Quick Look
|Use||Acute and preventive treatment of migraine; not usually a first choice of therapy.|
|Side effects||Almost none|
|Taken how?||Worn or held on head, neck, or arm, depending on the device.|
|Cefaly Acute, Cefaly Migraine, Cefaly Dual||Cefaly|
The Food and Drug Administration has approved migraine devices as an alternative treatment option for preventing and managing migraine symptoms.1-4 While prescription drug treatment is often the first line of defense, these portable medical devices may be used with or as an alternative option to reduce migraine pain. Migraine devices generally have limited side effects, particularly compared to medications. They have shown effectiveness in reducing the number of headache days and the duration of migraine attacks. You do not need surgery to use these devices. The devices are rechargeable and battery-powered.1-4
How do migraine devices work?
Migraine disease is associated with hyperactivity in the brain. Although each migraine device works differently, they all involve neuromodulation. Neuromodulation involves the stimulation of nerves which can affect brain activity through electrical currents or magnetic fields.5 Each migraine device is applied to a different part of the body. They affect different parts of the nervous system.1-4
Are migraine devices abortive or preventive?
Some—but not all—devices are approved for both acute (or abortive) and preventive treatment. They are used differently for each purpose. To stop a migraine attack, you treat when the pain starts. To prevent a migraine, you use the device one to three times daily, depending on device. Talk to your doctor about the best way to use the device based on your migraine patterns.
Do I need a prescription for migraine devices?
Each device requires a prescription from your health care provider. Some devices must be purchased. Others are rented. Some require ongoing refills. Others are limited to a certain number of uses. Insurance coverage varies.
Migraine device options
Migraine devices can be used for the acute treatment or prevention of migraine. They are:
- Cefaly® (acute and preventive treatment)
- eNeura® sTMS™ mini (acute and preventive treatment)
- gammaCore Sapphire™ (acute and preventive treatment)
- Nerivio™ (acute treatment only)
As all these devices require a prescription, some also require prescription refills that contain specific treatment programs within precoded cards that are read by the device. These programs are customized to meet individual needs.1-4
Migraine devices: preventive and acute
Cefaly® has three devices: Acute, Prevent, and Dual.1 It is worn on your forehead. Acute sessions last for 1 hour. Preventive sessions last for 20 minutes. You can adjust the intensity of the session. The device uses electrical energy to stimulate the trigeminal nerve. The trigeminal nerve runs from the brain to the face. This technique is called external trigeminal nerve stimulation or eTNS. The device can be purchased from the manufacturer’s website with a prescription.
sTMS mini™ is a device that you hold at the base of your skull. sTMS mini is approved for acute and preventive treatment of migraine for adults and children 12 years of age and older.6 The device delivers one pulse of magnetic energy at the push of a button.6 Several pulses may be needed. See instructions for specific recommendations. This technique is called transcranial magnetic stimulation or sTMS. The device is rented. The prescription is refilled by replacing the SIM card. Older models of this device include the Spring TMS and Cerena.
gammaCore Sapphire™ is a device that you hold against your neck. gammaCore is approved for acute and preventive treatment of migraine.7 This device is also approved for acute and add-on preventive treatment of cluster headache. The device delivers mild electrical energy to the vagus nerve.7 The vagus nerve runs from the brain through the face to the belly. This technique is also called non-invasive vagus nerve stimulation or nVNS. One stimulation lasts 2 minutes. A treatment may include several stimulations. See instructions for specific recommendations. You can increase the intensity level as needed. A gammaCore Refill Card is needed for ongoing use.
Migraine device: acute treatment only
Nerivio™ is worn on the upper arm.8 You control the intensity of the treatment through your smartphone. The intensity should be strong, but not painful. Nerivio is approved for acute migraine treatment of migraine with or without aura in patients 12 years or older. The device delivers weak electrical pulses. These pulses turn on pain-blocking mechanisms in the brain. This technique is called peripheral electrical stimulation or PES. Each treatment lasts 45 minutes. The device is good for 12 treatments.
How well do these devices work?
The clinical trials for each device had different designs and populations.9-13 These differences make it difficult to compare the results. The size and quality of these trials vary.
In general, studies of acute use show that:9-12
- 36 percent to 63 percent of people report 50 percent reduction in pain at 1 hour.
- 17 percent to 30 percent of people who use these devices for acute treatment are pain-free at 2 hours.
In some studies and on some measures, the placebo group (no treatment) had similar results as people treated with the device.10,12
In clinical trials, people who use these devices had about 2 fewer migraine days per month.6,14,15
Who is a good candidate for treatment with a device?
Devices may be a good option for people who cannot take migraine medications.16 Devices may provide relief for people who do not respond to medications.
Who should not be treated with a device?
It is important to read the manual for your specific device. Warnings and precautions vary. In general, these devices are not suitable for people with:
- Implantable devices, such as a pacemaker or hearing aid
- Metal implants, such as stents or bone plates
These devices have not been studied in children or pregnant women. They may not be safe for people with epilepsy or heart problems. Talk with your doctor about your past medical history, including any history of head or neck conditions, disease, or injury. In addition, be sure to share the medications you take before starting with any migraine device. They can help determine how your current migraine treatment plan will be affected and which will be safe for you to use – if it is affected at all.1-4
Side effects of migraine devices
Migraine devices are an important option to help patients who may be sensitive to the side-effects of migraine drugs, or for those who want a drug-free approach. Each person may respond differently to specific treatments.1-4
Each kind of device may have its own set of possible side effects. The long-term effects of these devices are unknown. Most of the symptoms end shortly after the end of each treatment session.1-4
People in clinical trials had very few side effects from using these devices.17 Side effects included:
- Pain, irritation, or discomfort where the device was held or worn
- Muscle spasms or twitching
- Mild tingling, pricking, pins and needles
- Headache or migraine
Are migraine devices right for you?
These migraine devices are an option to improve quality of life and reduce or eliminate migraine pain. They may be enough to prevent or treat migraine for some people. However, they are just one form of migraine treatment. Because each person with migraine experiences a highly individual set of symptoms, treatments are determined based on the person’s symptoms, their age, general medical condition, and how they respond to different therapeutic options.1-4
It is important for people with migraine to see a neurologist or headache specialist who is trained in the appropriate use of these neuromodulation devices. Specialists understand how these devices work, for what conditions they are appropriate, and whether using these devices is safe considering each person’s individual medical condition.1-4