That Star Wars Looking Device: A Review of Cefaly For Migraine

WHAT IS CEFALY?

Cefaly is a TENS unit head piece that attaches to the forehead via an adhesive electrode, and is becoming a first line treatment for many migraine and headache sufferers.  Cefaly sends electrical impulses through the brain and is specifically designed for migraine/headache sufferers as an alternative or compliment to medication. Cefaly was available in European countries for years before it was finally approved by the FDA in March of 2014. Back in 2014, it was very difficult to find solid information and reviews on Cefaly because there was only a small population using it. However, it quickly gained popularity here in the states and now there are a host of reviews from users and medical journals online.

Modern medication used to treat migraines generally comes with too many undesirable side effects, making migraines even more difficult to treat. Cefaly is an alternative to these medications because the makers boast of very few side effects which are all reversible. According to the Cefaly website, side effects could include: intolerance to the sensation on the forehead (1.25%), feelings of fatigue during and after the session (.64%), headache after one session (.52%), and irritation of the skin on the forehead (.42%).


HOW DOES IT WORK?

 Most headaches and migraines involve the trigeminal nerve, a cranial nerve located in the center of the brain, with nerves extending to the forehead, the facial region, reaching to the sides above the ears, as well as behind the eyes.  Cefaly targets the trigeminal nerve with neurostimulation, producing a "relaxing effect" to these nerves and therefore decreasing migraines. The makers of Cefaly claim regular use of the device will eventually reduce the number of migraine and headache attacks, mainly due to precise stimulation of the trigeminal nerve. In order to get the full benefits, patients need to use the device at least once a day, for a full session each lasting 20 minutes.  I heard the CEO of Cefaly, Pier Rigaux, speak at the Migraine World Summit this year and he recommended using it twice a day in order for it to be most effective.

Those who would most benefit from Cefaly have one or more of the following conditions:

Common migraine

Migraine with aura

Ophthalmic migraine

Episodic migraine

Chronic migraine

Menstrual migraine

Anterior tension type headache

Posterior tension type headache

Chronic headache

Occipital neuralgia

DID IT WORK?

I first heard about Cefaly from my friend Eric in 2014 when he posted an article on his Facebook page for his wife who had recently been struggling with migraines, and was then later diagnosed with fibromyalgia.  As a chronic migraine sufferer at the time, I was absolutely fascinated by the possibility of a TENS type unit that could be used for migraine, in place of medication.  I immediately began doing my research and trying to figure out if it was right for me. The Cefaly website claimed an astounding 71% patient satisfaction rate and a 75% reduction in headache medicine use. Because there is a 60 day money back guarantee, they base their satisfaction rate on the amount of patients that do not return the device. In 2014 I could only find a few reviews of people actually using Cefaly, and very little in medical journals, but today you can find a plethora of information online. You can also find testimonials of people using Cefaly on their website here, and studies since 2014 are showing around a 50-60% satisfaction rate among patients who use the device regularly for 60 days.

In 2014, I convinced my doctor to write me a prescription for Cefaly and I was so excited to try it. The Cefaly comes with 3 electrodes that last anywhere from 15-30 uses.  Before placing the electrode on the forehead slightly above the eyebrows, it is important to wash the forehead with rubbing alcohol. This makes the electrodes last longer. The device itself rests on the electrode and once you push the start button, immediately you can sense the electrical impulses on the top of your head. The intensity rises and peaks in intensity at 12 minutes. It took me a long time to be able to build up to full strength as it was a bit painful in the beginning, although nothing compared to the pain of a migraine or headache. Even though the Cefaly instruction manual says you can move about as normal, I found I was only comfortable when lying down. This lasted for about two months, but I am now able to fold laundry and pick up toys while doing a session at full intensity.  I can honestly say I am not sure it has done a lot for me in the treatment of migraines and headaches, as I saw very little change after using the device for three months. I am a firm believer that migraine treatment is a 360 approach and there is not a one cure-all, but instead the implementation of diet and lifestyle changes, holistic approaches, as well as medical intervention may all be necessary. Even though I don’t believe Cefaly worked for me, I still use the Cefaly regularly.  If nothing else, it does feel really good during a headache or migraine attack, and occasionally I notice a reduction in pain after use.

CEFALY II AND FUTURE POSSIBILITIES FOR FIBROMYALGIA

Just this week, Cefaly announced the release of what they are calling the Cefaly II, exclusively to the United States.  It works the same as the first Cefaly, except it is a smaller device and sits on the forehead magnetically, instead of the larger band. Because Cefaly II is so much smaller, it is easier to travel with and even “wear” out in public. (You won’t see me out in public wearing

either device.) It also comes with a power cord and adapter for recharging the battery, whereas Cefaly I requires 2 AAA batteries. The cost is still the same. For $349 USD, you get the Cefaly and 3 electrodes, plus shipping and handling, for a total cost of $364 USD. Keep in mind, the Cefaly requires a prescription and most insurances do not cover it. There have been reported cases in which insurance companies paid a partial amount, but you need to contact your own company to find out. There is also the added cost of replacing electrodes approximately every three months or less which costs $25 for three. Given Cefaly is having around a 50% success rate, I think it is definitely worth giving it a try if you can afford it. Worst case scenario, it doesn’t work and you simply return it in 60 days for your money back.

I recently learned on the Cefaly website about the exciting possibilities for the use of Cefaly in Fibromyalgia. Cases of Fibromyalgia in America, particularly in women, are on the rise and like chronic migraine is extremely difficult to treat. The University of Cincinnati announced earlier this year, they were beginning clinical trials to see if Cefaly was also effective for the chronic pain associated with fibromyalgia. According to Leslie Arnold, professor and physician at the University of Cincinnati, “…Fibromyalgia amplifies painful sensations by affecting the way your brain processes pain signals,” and since Cefaly targets the pain center of the brain, there could be a great opportunity for treating fibromyalgia. The clinical trial is open to adults ages 18-65 who have a diagnosis of fibromyalgia. Everyone who enrolls will receive a Cefaly at no cost and if patients show improvement, they will go on to controlled studies. You can find more information about this at Fibromyalgia News Today.

Could It Be Tyramine?

On a cold morning in early February 2015, I woke up with what turned out to be the worst migraine of my entire life. At the time, I was used to having migraines that lasted three, five, sometimes even seven days. But this one was different. Pain meds didn’t touch it and no matter what I did, it wouldn’t go away. For five weeks it stayed there. During those weeks, I paid a visit to both Urgent Care and the ER, but could not get relief. I prayed every single night for it to go away, but it didn’t. Sometime during week three, I desperately made an appointment at a reputable Headache Clinic in Chicago.

It snowed the entire drive to Chicago and by the time we got there, it was late and we were so hungry we chose the quickest option: Taco Bell.  I woke up in the early hours of the next morning with what I knew to be food poisoning. That, coupled with this daily migraine---death felt like a more viable option.   I was so sick and dehydrated by the time I got to my appointment, I laid on the floor in the waiting room curled up in the fetal position, my head throbbing. The doctor took one look at me and admitted me to the hospital.

It was during this hospital stay, I was first introduced to Tyramine and the idea it could be a problem. I was one of those Migrainers who did not believe my diet contributed that much to my migraines.  The literature I was handed insinuated I would have to cut certain foods out of my diet, you know, to see if Tyramine was a trigger for me.  Too many of those foods were my favorites. There was no way I was giving up my red wine.  Feeling better from the pain meds and all the IV fluids, I tossed the literature aside and ordered myself a Lou Malnalti’s deep dish cheese pizza.

I was released from the hospital a few days later, and I was only a half hour down I-65 when the same migraine returned. In the days following, I got desperate and began giving this idea of eliminating trigger foods another consideration. I started doing my research and decided it was worth a try. I wish someone had told me about tyramine 14 years ago.

WHAT IS TYRAMINE?

Tyramine is a chemical compound produced by the breakdown of an amino acid called tyrosine.(3)  Tyramine naturally occurs in many foods, particularly aged or fermented foods and is often found in cheese, cured meats, beer and even ripe bananas.  It also occurs in food when it has been prepared and stored for a long time. Due to its chemical structure, tyramine is also called a monoamine. There is an enzyme in the human body called monoamine oxidase (MAO). This enzyme breaks down monoamine and processes tyramine. (2) Some people like me, have a problem breaking down tyramine when they consume high levels of it. This is often presented in physiological symptoms such as: high or low blood pressure, nausea, vomiting, heart palpitations, and of course, migraine and headaches.

Experts have known since the 1950s that tyramine is a problem for some people and in the 1960’s they began suspecting it could be a trigger for migraine headaches.  Researchers are still trying to figure out why tyramine might trigger headaches and migraines in some individuals and not in others. It was observed that certain people with migraines, are also deficient in the MAO enzyme, and would get a headache after they consumed food high in tyramine.  Another explanation is that tyramine causes the brain to release Norepinephrine rapidly, leading to an imbalance of brain chemicals, and producing bad side effects like migraine. (2)

I now know, I carry 2 SNP’s for the MAOA gene, which is linked to tyramine and affects the way the body processes it. For me it causes migraines. For someone else, it might cause high blood pressure or a host of other symptoms.

I cut tyramine out last year, or at least I thought I had. I wasn’t entirely convinced tyramine was a problem for me, and frankly, getting rid of tyramine is hard, really hard. It is hidden in so many things, and requires strictness with food preparation and storage. Tyramine grows in leftovers in the refrigerator if they sit past 24-48 hours, in meat if it is not prepared immediately or frozen, and fruits and vegetables if they are not fresh.  High levels of it are found in bananas and avocados as they ripen. And then there is the cheese. Who doesn’t love cheese? I cheated often on this diet because I found it REALLY difficult to give up pizza.

I am a carrier of the MAOA gene, indicating tyramine is a BIG problem for me.  I have not consumed high levels of tyramine since.

FOODS HIGH IN TYRAMINE

If you struggle with migraines or headaches, and are serious about improving your quality of life, then an elimination diet is absolutely necessary. Tyramine is a great place to start because we know there is a link between tyramine and headaches.

If you search the web, you will find hundreds of opinions on what has tyramine and what should be avoided. The National Headache Foundation gives a recommendation here. The chart on this link divides food into columns and I would argue the “Use With Caution” column should also be entirely avoided in the beginning.  

High amounts of tyramine are found in aged cheeses:  blue, cheddar, Swiss, Gorgonzola, Gouda, Parmesan, Romano, feta and Brie. Aged, dried, fermented and pickled meats should be avoided such as: bacon, sausage, liverwurst, pepperoni, salami, ham, hot dogs and corned beef. Meat should either be consumed the same day it was bought or frozen immediately. You will find high levels of tyramine in breads and baked goods that contain yeast--homemade yeast breads, sourdough bread and yeast extracts. (Always read labels. Lots of seemingly healthy snacks such as pretzels contain yeast extract.) Very ripe or dried fruits can also be a problem.  Bananas and avocados are high in tyramine, but other fruits and vegetables will also have tyramine as they lose their freshness.  Avoid fermented vegetables like sauerkraut, kimchee, pickles, certain olives, and other fermented foods like tofu and bean curd.  You can forget soy sauce, beer, and white and red wine. Nuts, specifically peanuts and peanut butter are also culprits. Don’t ever thaw food at room temperature. Instead, use the microwave and be aware that simply cooking food will not lower the tyramine content.

An elimination diet requires time and patience, so it is unlikely headaches and migraines will disappear overnight. I am a firm believer in giving an elimination diet AT LEAST 3 months. Some nutritionists will say 6-8 weeks, but I know my body is a slow responder. So, I think 3 months is a fair amount of time to try this tyramine free diet. After eliminating, you can reintroduce foods with tyramine and see if it causes a problem. Just remember, a food induced headache or migraine may not show up for 24 hours, so keeping a food diary is also a really good idea.

For me, tyramine is a problem. I know it contributes to my migraines and headaches if I consume it. BUT, it is only one piece to an extremely complicated puzzle that is my body. There were so many other diet and lifestyle changes I had to make to get on the right path of improving my quality of life. Given that experts know tyramine is definitely a problem for some people, it is a good place to start.

1.       “Low Tyramine Diet For Headaches,” The National Headache Foundation Online. October 25, 2007. n.p. July 9, 2016.

2.       “Tyramine and Migraines, “ WebMD. WebMD Medical Reference. January 24, 2015. Referenced July 9, 2016

3.       Van Eaton, Jamie. “Tyramine- Free Diets,” Healthline. December 2, 2014. Referenced July 7, 2016

Medical Marijuana For Migraines

One needn't look far to find research pointing to the amazing benefits of medical marijuana for certain medical conditions. And because medical cannabis is being used to treat multiple chronic pain conditions, migraine sufferers are wanting to know if it can help them also. New research may suggest medical cannabis is useful not only for treating migraines acutely, but also for preventing them. While the legalization of marijuana is still highly controversial among individuals and in many states (I live in Indiana where medical marijuana is still not legal), one cannot dismiss the fact there are amazing uses for medical marijuana in the area of pain management. Those who have lived in chronic pain, from either migraines or other diseases, are willing to try almost anything. I know I am, particularly after failing multiple treatments.

Dr. Eric Baron, a top ABPN Board Certified Neurologist and a UCNS Diplomat in Headache Medicine at Cleveland Clinic Neurological Institute in Cleveland, Ohio, spoke specifically on this topic at The Migraine World Summit this year. He gave an excellent history of medical cannabis and the potential benefit for migraine and pain. While it's not surprising cannabis was being used in ancient times by the Greeks and Chinese for pain--who knew as early as the mid-1800's, the Western World was also using it, and specifically in the treatment and prevention of migraines? Dr. Baron discusses this and also gives an in depth summary of why medical cannabis was made illegal in the US.

As a headache doctor that sees chronic patients daily, Dr. Baron discusses why cannabis might also work for migraineurs. Cannabis works through "neurological pathways and electrical channels" in the brain that could also influence the same receptors as modern migraine medication and opioid medications. For example Triptans, a class of abortive migraine medications target the serotonin pathways in the brain. Cannabinoids seem to act in the same way. A problem however, is there have been no clinical trials for medical marijuana and migraine. According to Dr. Baron, we only have case reports and a retrospective study done in 2016. This study looked at 121 patients who used medical cannabis to treat migraines over the course of months. Again as a retrospective study, it showed 85% of patients had a significant decrease in migraines, averaging a decrease from 10.2 migraines a month, down to 4.6. There is definitely a need for more research and clinical trials for the use of medical cannabis and migraines.

You can watch Dr. Baron's fascinating discussion below. You can also follow him on Twitter: 
+Neuralgroover .