Common Questions About Cefaly
Cefaly, an external trigeminal nerve stimulator, has left many people living with migraine with tons of questions. Here are answers to a comprehensive list of frequently asked questions. If you have a question that’s not answered here, please comment below!
Where can I get Cefaly?
You can place an order for Cefaly® on the Cefaly website. Cefaly is FDA approved for over-the-counter (OTC) use without a prescription in the United States (US). It is also available OTC worldwide to people with diagnosed migraine.1,2
Is Cefaly available outside of the US?
Yes! Cefaly is available worldwide. Support for Cefaly customers in Canada and outside of North America is available via:1
- Canadian users: firstname.lastname@example.org
- Users outside North America: email@example.com
Phone (details are provided on the Cefaly website)
How much does Cefaly cost?
Cefaly Connected, the standard model, is currently $424, with varied shipping costs depending on where you are. Electrodes for Cefaly Connected are $25 for a pack of 3.1
Is Cefaly returnable?
Cefaly offers a 90-day satisfaction guarantee on their products. If you are not satisfied, you may return your device within 90 days of delivery for a refund. Cefaly also offers a 3-year limited warranty for protection against defects in the device. Not included in the warranty are:1
- Charging cables
- Other accessories
Will insurance pay for Cefaly?
No, health insurance does not cover Cefaly. But Cefaly may be eligible for payment through a Health Savings Account (HSA) or Flexible Spending Account (FSA). Contact your insurance company directly to confirm. For veterans, Cefaly is covered through the VA healthcare system.1
What forms of payment are accepted?
- Credit cards (Visa, Mastercard, or American Express)
- Apple Pay
- Microsoft Pay
- Google Pay
- iDEAL (accepted in the Netherlands)
In the US, they provide options for payment plans via PayPal Credit and Affirm.1
Is it useful for everyone with migraine?
Not necessarily. Cefaly is intended to treat episodic migraine with or without aura in people ages 18 years or more. Talk to your doctor if you think Cefaly may be right for your migraine.1
Does Cefaly hurt?
Cefaly’s marketing materials say no. Intolerance to the sensation or pain was reported by 29 out of 2,313 people in the patient satisfaction study. Cefaly is also meant for a user to slowly increase the intensity of the stimulation from a low setting. Many find the stimulation bearably uncomfortable, though it can be intolerable for some.1
What if the intensity is too strong for me?
New Cefaly users should start the device on a low setting to get used to the sensation. You should feel a strong vibration or stimulation but no pain. The program will slowly increase in intensity over the course of treatment. You can also push a button at any point to keep the level where it is if/when the intensity becomes too much.1
There is a slight chance that even the starting intensity may be too uncomfortable for you, but this risk is low. With regular use, you are likely to adapt to the sensations of the device.1
How effective is Cefaly?
In 1 trial, 10 people with episodic migraine attacks treated 3 of their attacks with Cefaly. As a result:3
- Total relief without rescue medication was reported in 12 percent of the attacks.
- Incomplete relief with rescue medication was reported in 42.5 percent of the attacks.
- No effect was reported in 45.5 percent of the attacks.
In another study, Cefaly was effective and well tolerated as an acute treatment for migraine attack symptoms present for at least 72 hours. It also reduced headache severity on average by 46 percent.3
Cefaly has also been shown to reduce the need for rescue medication in many patients.3-5
A study cited on Cefaly’s website showed the results below:6
- 26 percent of Cefaly users: pain free after 2 hours of treatment
- 57 percent of Cefaly users: most bothersome migraine symptom went away
- 43 percent of Cefaly users: all of their migraine symptoms went away
How well Cefaly works for your migraine may depend on many factors. In general, Cefaly has strong support as a supporting therapy to be used at home. If you are willing to try a treatment that may not fully get rid of your migraine but will likely reduce acute migraine severity and the need for drugs, then Cefaly may be right for you.1
Is Cefaly safe?
Based on press materials, all of the side effects reported in studies were minor. They also fully stopped when the device was not in use. No severe side effects were reported in the study. Common side effects included:1,2
- Intolerance to the buzzing sensation or pain
- Sleepiness during or after device use
- Forehead skin redness
- Allergic reaction at the electrode site
If you experience any severe side effects while using Cefaly, or if side effects last more than a few weeks, stop use right away, and consult your healthcare provider.1
Will Cefaly stop a person’s migraine attacks completely?
Patients who received relief from the device in studies reported reduced migraine frequency but not a complete stop of attacks. They also did not report a reduction in the intensity of their attacks.1,3-4
Can I use it to stop a migraine attack that’s in progress?
You can use the ACUTE treatment mode for migraine attacks in progress. This mode is a 60-minute program meant for use at the first migraine symptoms.1,2
How long will it take to notice any improvement?
ACUTE treatments are meant to provide relief after the first few 60-minute sessions. For PREVENT treatments, it takes 2 to 3 months to notice a reduction in migraine frequency, according to the company.1
How does Cefaly work?
Cefaly is a transcutaneous electrical nerve stimulator (TENS). It is guided by the same principles that guide implanted nerve stimulation for migraine. But how the device works is not well understood.1,4-5
The trigeminal nerve plays a key role in migraine pain. Stimulating it is thought to change migraine- or pain-related brain activity. This change raises the migraine threshold and lowers pain. Cefaly is an external device meant to stimulate the trigeminal nerve and desensitize it.1,4-5
Do I need to use it every day?
Cefaly is meant for daily use to prevent migraine attacks.1,2
How long is each treatment session?
The PREVENT program is 20 minutes long, but you can stop it by removing the device. Cefaly’s ACUTE program lasts 60 minutes. Ask your doctor for exact recommendations regarding your own treatment.1,2
What programs does Cefaly have?
Cefaly has 2 modes. The PREVENT mode is intended as a long-term preventative treatment. The ACUTE mode is meant for use at the start of a migraine attack. ACUTE is a 60-minute program meant to treat migraine attacks when they begin. It is also meant to stop or relieve your migraine pain. For best results, the ACUTE mode should be used at the first sign of a migraine or aura.1,2
How long does an electrode last?
Electrodes can be reused as long as they adhere well to the skin on the forehead. Store electrodes in a zip-top bag between uses to prevent them from drying out and losing effectiveness. An electrode’s conductivity may decrease the longer you use it. Proper care of electrodes can help maximize the number of treatments they can provide. The Cefaly website offers tips for getting the most out of each electrode.1,7
Is there anyone who shouldn’t use Cefaly?
Cefaly should not be used by people who:1
- Have implanted devices in the head that are metal or electronic
- Have pain of unknown origin
- Have a heart pacemaker or defibrillator
- Are allergic to acrylate
Cefaly also should not be used:1
- When driving
- Within 3 months of trauma to the skull or face
- If you have a rash or skin condition where the electrodes are placed
Can pregnant women use Cefaly?
Those who are pregnant or could become pregnant should check with their doctor before using this device.1
Can children use Cefaly?
Cefaly is meant for use in people 18 years of age and above. No testing has been done on those less than 18 years of age, so its safety in children is unknown.1
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