Cefaly: External Trigeminal Nerve Neurostimulation for Migraine Headaches

Review by Darius Zoroufy, MD

I have had migraine headaches my entire life.  My earliest childhood memories are little preschool Darius asking his mom to help him because my head hurt.  I had intermittent headaches throughout childhood.  As I grew up, so did my headaches.  They became much more frequent and more severe.   Although ancient civilizations may not have been drilling holes in skulls of living people to relieve headaches, my headache pain has been bad enough that I would have agreed to trepanation, if a 7000 year old South American healer with a chisel and hammer were offering one.  

When I get a migraine the intensity of the pain is somewhere between moderate (stubbing my toe) and severe (pounding my thumb with a hammer – repeatedly).  I do not get visual auras, but I do get cognitive slowing and my coordination is affected.  When I repeatedly fail to correctly enter the password that unlocks my clinic computer, it is like the sky starting to darken before a Midwestern thunderstorm.    

Triptans, a class of medicines that work on specific serotonin receptors, usually lessen my headaches, but it is a little bit like my first try at snowboarding:  I stood up after each fall, but I grew weary of my head slamming into the ground.  I have tried a lot of preventative medications, to no avail:  

  • Beta blockers – no help and really fatigued

  • Topirimate (Topamax) – minimal change and cognitive changes (a.k.a. “Dopamax”)

  • Gabapentin – no help

  • Riboflavin + Coenzyme Q10 + Butterbur + Magnesium – bright yellow urine, which is amusing, but not particularly useful

  • Daily exercise – I am in better shape, but I still get headaches.  

This year my migraines have decided to visit me nearly every day.  In order to avoid missing work I have taken extremely high doses of sumatriptan (i.e. 400 mg oral + 18 mg subcutaneous) to relieve the pain so I can work.  Unfortunately, relieving the pain does not relieve the cognitive and coordination problems.  I can do my work, but it takes me a lot longer.  


Dr. Wong

I asked my primary care doctor for help and he suggested that I seek advice from a neurologist.  So a few months ago I began to see Dr. Anna Wong in the neurology department of Seattle’s Swedish Medical Group.  Dr. Wong and I have cared for some of the same patients so I knew that she is a smart and compassionate physician, well-liked and respected by patients and her physician colleagues.  After a thorough assessment, Dr. Wong suggested that I consider Botox injections to reduce the frequency and severity of my migraines.  When used for migraine, Botox is administered differently than for cosmetic purposes, instead focusing on the forehead, temples, back of the head, and shoulders.  My first round of Botox seemed to reduce my headaches for a few weeks, but the effect wore off about 1 month into the 3 month cycle.  My second round of Botox seemed to only slightly reduce my headaches.  I decided to go back to Dr. Wong and ask for help.  


Cefaly

In addition to ordering an MRI to look for things that are unlikely but not impossible (e.g. tumor, aneurysm, clot, Chiari Malformation, abcess, etc.), Dr. Wong asked me if I wanted to try Cefaly.  I said yes, because I had a headache at the time and I would have said yes, if she had pulled out a chisel and a hammer and offered trepanation.  She explained that Cefaly is an electrical neurostimulation device that stimulates the first (V1) branch of the trigeminal nerve with a specific pattern of pulses that can diminish migraine pain during a headache and can reduce the frequency of migraines.  Her office has a Cefaly Dual demonstration device and she let me borrow it that afternoon.  


First use of Cefaly

The medical assistant cleaned my forehead with an alcohol prep pad and then applied the gel electrode above my eyebrows, explaining that I should keep the electrode, since it is reusable for 20 uses.  She then took out a lightweight silver object with a power button on the front and a couple of magnetic electrode contacts on the back.  She popped it onto my forehead electrode where the magnets held it in place.  She pushed the button once for a one hour session, and I walked back to my office (conveniently located in the same medical building).  

For the first few minutes, nothing seemed to happen.  I was just standing there with a silver diamond on my forehead as if I were an alien from the planet Dork.  Then I started to feel something. At first, it was like an itching, prickling sensation.  Then it moved on to a buzzing.  The sensation increased for about 10 minutes and then stabilized.  I could feel it in my forehead, temples, and even my upper eyelids.  I found the feeling somewhat uncomfortable, yet relaxing and pleasant, like a deep tissue massage:  it hurts, but you don’t want it to stop.  

As far as my headache, it felt like it was being driven back from my temples to the base of my skull.  The longer the device was on, the more my headache diminished.  After an hour the headache pain was minimal and the surface of my head felt a gentle, pleasing numbness.  I definitely wanted to try it again.  

The next day Dr. Wong let me borrow their Cefaly for the weekend to test it at home.  She told me that I can use it as much as I wanted to, so I did.  On Saturday, I used Cefaly for 3 one hour “acute” sessions and 3 twenty minute “prevent” sessions and I did not have a migraine all day.  I am aware that 4 hours of use per day is not the recommended dose, but there does not seem to be any downside to using Cefaly and I would do just about anything not to have a headache.  On Sunday I used Cefaly again, but the battery had been depleted, so I needed to recharge it.  While it was plugged in, I decided to write this review as I sat pining for it.  

Cefaly is best used when relaxing.  The sensation is intense enough to be distracting, so it is best not to work or drive while using it.  It is probably best to use it for the 20 minute “Prevent” mode right before going to sleep and for the 1 hour “Acute” mode when lying down and trying to get rid of a headache.  


What is Cefaly?

Cefaly is the brand name for an FDA approved device available to patients in the United States by prescription only.  It delivers an electrical current to a gel electrode applied to the forehead that delivers biphasic symmetrical pulses at a frequency of 100 Hz at a maximum current of 16mA.  This electrical current provides neurostimulation to both the left and right first branches of the trigeminal nerve (V1).  It has been shown in randomized, controlled trials to reduce the intensity of acute migraine headache pain by 59%, which was approximately twice the pain relief of the sham placebo device.  It has also been shown to prevent migraine headaches when used 20 minutes per day.  A randomized, placebo controlled, double blind trial showed a significant reduction in days per month with migraine, number of migraine attacks, severity of migraine headache, and number of doses of acute migraine medications.  

As I write this review I have the Cefaly I borrowed from Dr. Wong pleasantly buzzing away in the “Prevent” mode on my forehead.   I intend to get my own Cefaly Dual with both the “Acute” and “Prevent” modes to try to reduce the number of migraine attacks.  I will also recommend that any of my patients with migraines see Dr. Anna Wong to discuss options like Cefaly.  Since 18% of women and 6% of men suffer from migraines, this is a common problem and a non-drug solution like Cefaly can play an important role in their treatment plans.