Credit: Thinkstock Since my post _ Cefaly Device Approved by the FDA for Migraine Treatment_ was published, there have been many questions and much discussion about it. We’re all excited to have another treatment to add to our toolbox, and we’re all quite curious about the Cefaly.
Many of the questions are addressed in the FAQ that the manufacturer, Cefaly Technology, has put together, and they’ve given me permission to publish those questions and answers here:
- What is Cefaly ® and how does it work? The Cefaly ® medical device is an External Trigeminal Nerve Stimulator (eTNS) that is worn similar to a headband or exercise band. There are no wires. To use the Cefaly ® place a self-adhesive electrode on the forehead then place the band-like device on the electrode.
Cefaly ® is operated by 2 AAA batteries of 1.5 V - each battery is built into the inside of the band. A single push of a button on the front of the Cefaly ® activates the session.
- What are the uses for which the Cefaly ® medical device is being prescribed in the U.S.? Cefaly ® is a prescription-only medical device for the preventative treatment of adults with frequent migraine (two to eight episodic migraine attacks each month).
- Is Cefaly ® a drug? If not, then why is it prescribed? Cefaly ® is not a drug. It is a powerful medical device that’s used in the prevention of episodic migraines and the first of its kind to offer external cranial neurostimulation. U.S. regulations require such a device be made available by prescription.
- How long does a Cefaly ® session last? Each Cefaly ® session is programmed to last 20-minutes but you may interrupt your session at any time by removing the device from your forehead.
- Am I supposed to use the Cefaly ® every day? Check with your doctor for any specific instructions but in general, the Cefaly ® is best used as a preventative measure in one 20-minute session daily.
- Is there only one program or are there different intensity levels? There is a single program. The intensity increases slowly and can be stabilized when it becomes uncomfortable. Several sessions are usually needed to get used to the feeling and reach the maximum intensity level.
- Is it safe? What if the intensity is too strong for me? Cefaly ® is very safe but if at any moment you feel the intensity is too strong for you, simply press the button to stabilize the intensity or remove the device to stop your session entirely. In clinical trials, only 4.3% of people reported side effects – all of which were minor and fully reversible. The most frequent is intolerance to the tingling sensation during the session and the most severe was skin irritation caused by the gel used in the electrode.
- How often must I change the electrode? Each electrode will last through 20 uses. The electrodes contain a conductive gel, which needs to stay moist in order for the Cefaly ® device to work properly. We suggest storing an open electrode in a tightly sealed plastic bag to prolong its life.
- Does it hurt to use the Cefaly ®? The Cefaly ® isn’t necessarily painful but the sensation can be uncomfortable at first.
- Are there any conditions when Cefaly ® should not be used There are five contra-indications to Cefaly ®:
® should not be used when driving.
® should not be used if you’ve suffered recent trauma to the skull or face (less than 3 months).
® should not be used if you have a rash or skin condition in the area of the forehead where the electrode is placed.
® should not be used if you have an allergy to acrylate.
® should not be used with a pacemaker.
- Can Cefaly ® be used by pregnant women? Women who are pregnant or could become pregnant should check with their doctor before using Cefaly ®.
- Can children use Cefaly ®? Cefaly is for adults and not for children.
- How long does it take to experience an improvement with Cefaly ®? There are people who respond quickly and may experience a reduction in migraine frequency within 2 weeks and others that may need 2 to 3 months. On average, 2 months is enough to experience significant improvement.
- What are the benefits of Cefaly ®? Cefaly ® will help reduce the frequency of migraines. For instance, a patient with four attacks per month can expect to have only one per month. Migraineurs who respond to the treatment have their anti-migraine drug consumption reduced by up to 75%.
- How effective is Cefaly ®? In a clinical trial 70% of patients were satisfied with Cefaly ®. In practice ("real world") 81% of regular user are very satisfied.
- Can I use Cefaly ® to reduce pain during a headache? The efficacy of Cefaly ® has been demonstrated in clinical trials for migraine prevention but many patients report that they are using Cefaly ® during a headache and that it reduces the pain or stops the headache.
Some questions are being asked that aren’t covered in the Cefaly FAQ:
- Is there more than one type of Cefaly device? Yes. The Cefaly that has been approved by the FDA is different from the Cefaly device available in Canada and Europe.
- How does the U.S. device differ? The U.S. device has one program, a prevention program. The Cefaly available in Canada and Europe has three programs:
1. attack treatment, to abort; 2. prevention treatment; and an 3. "antistress" treatment.
- Why is the U.S. device different? The third program was designed as a demo program to be used to relax people without Migraine who want to feel what the Cefaly does. The attack treatment program has a higher frequency than the prevention treatment and is less comfortable. Clinically, the attack treatment program hasn’t been demonstrated to be more efficient than the preventive program for aborting a Migraine. More studies are needed on the abortive program, so the device with only the preventive program was the only way to apply for FDA approval.
- How do I get a Cefaly device? At this time, the Cefaly that’s FDA approved in the U.S. is available only through the company’s web site, www.cefaly.us. On the page where the Cefaly is ordered, there’s an email address for sending in the required prescription. The prescription can be emailed by either the doctor or the patient. Then place your order on the web site.
- Is the Cefaly covered by insurance? That’s an excellent question, but the answer is as yet unknown. The FDA approval is so recent that we have no experience to answer this question. Cefaly Technology does not bill insurance companies, but most insurance companies permit submission of expenses for reimbursement. The Cefaly will probably fall under durable medical equipment for insurance purposes. I’m sending my receipt along with a letter from my Migraine specialist and a copy of the FDA approval press release to my insurance company. When they’ve responded, I’ll post and share my experience.
Summary and Comments:
The Cefaly is the only external trigeminal nerve stimulator (eTNS) of which I’m aware. It’s the first neurostimulator of any kind to be approved by the FDA for Migraine.
I’ve been using the Cefaly daily for Migraine prevention for the last six days. It’s too soon to tell if it’s helping. The plan my Migraine specialist and I have is for me to use it daily for three months, then compare my Migraine diary data for those three months to data from months before I started using the Cefaly. I’ll keep you updated on my experience with it.
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© Teri Robert, 2014 Last updated April 8, 2014.