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Discover how the Cefaly device offers relief from migraine through transcutaneous stimulation. Approved for its efficacy in reducing migraine frequency, Cefaly targets the trigeminal nerve to modulate pain networks. Explore its advantages, research findings, and potential for managing migraine effectively in this post.

What is the Cefaly device? 

Cefaly is a device that sends electrical signals to stimulate the sensory nerves of the face. These signals pass through the trigeminal nerve to the trigeminal nucleus in the brainstem, which is involved in initiating migraine. It is believed that by sending electrical impulses into the trigeminal nerve network, migraine can be controlled.

The first version of Cefaly resembled a tiara or diadem, while the newer version is smaller. 

What are the advantages of Cefaly?  

Many people avoid medications due to side effects. Cefaly, as an external device, has fewer side effects

How does Cefaly work?

Neurostimulation targets the frontal and temporal branches of the trigeminal nerve. The signal is relayed to the brain and modulates the pain networks to reduce migraine frequency. For more information and videos on how the Cefaly device works, please visit the Cefaly Technology YouTube Channel.

Is there research evidence that Cefaly works?

A Belgian research team conducted a randomized controlled trial named PREMICE to assess whether migraine could be prevented using a supraorbital transcutaneous stimulator. The study was subsidized by Belgian institutions, not by the manufacturers of Cefaly.

Who participated in the study?

The study involved 67 people with migraine who experienced a minimum of 2 and an average of 7 migraine days per month. It should be noted that NONE of the participants had chronic migraine or daily headache, nor were they taking preventive medications or experiencing frequent tension-type headache in addition to migraine. Most people who seek treatment for migraine have more than 4 per month. The study population was not the same as many of the people who are interested in using Cefaly.

How did the participants use Cefaly?

The protocol was 20 minutes per day for 3 months. The placebo group also used Cefaly but with weaker electrical stimulation.

Were there any side effects

 No adverse events were reported. In real life, people with chronic migraine who try the device may experience pain and allodynia from the electrodes and stimulation.  

What were the results?

  • Cefaly Group: Started with 6.9 migraine days per month, reduced to 4.9 days—a decrease of 2 days.
  • Placebo Group: Started with 6.5 migraine days per month, reduced slightly to 6.2 days—showing no significant improvement in migraine.

Other observed parameters:

  • Responder Rate (percentage that improved by more than 50%): 38% with Cefaly versus 12% with placebo. This means roughly three times as many people using Cefaly experienced significant improvement in their migraine compared to those using a placebo.
  • Satisfaction Rate: More people were satisfied with Cefaly (70% vs. 40%).  
  • Acute Medication Use: More people using Cefaly reduced their acute medication use (36% vs. 0%)

What can be concluded from this study?

  • Cefaly appears to be a promising technique for controlling migraine.
  • 4 out of 10 patients achieved a positive effect (50% improvement) with Cefaly.
  • Cefaly is well tolerated.
  • Patients had difficulty using Cefaly daily. It remains uncertain whether more consistent use could yield improved results.
  • The effect of Cefaly in patients with frequent or chronic migraine was not studied.
  • It is unclear whether it is beneficial to use both Cefaly and preventative medications, but it is possible to use both.

References

  • Vikelis M et al Clinical experience with transcutaneous supraorbital nerve stimulation in patients with refractory migraine or with migraine and intolerance to topiramate: A prospective exploratory clinical study. BMC neurology. 2017;17(1):97.
  • Chou DE et al. External Trigeminal Nerve Stimulation for the Acute Treatment of Migraine: Open-Label Trial on Safety and Efficacy. Neuromodulation. 2017;20(7):678-83.
  • Schoenen J, et al. Migraine prevention with a supraorbital transcutaneous stimulator: A randomized controlled trial. Neurology. 2013;80(8):697-704.

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