External Trigeminal Nerve Stimulation

A device designed to prevent and treat frequent episodic and chronic migraine

In May 2016 the National Institute for Health and Care Excellence (NICE) published guidance on the use of a transcutaneous electrical stimulation of the supraorbital nerve for treating and preventing migraine, in relation to the Cefaly© device.

What is external trigeminal nerve stimulation?

Most headaches and migraines involve the trigeminal nerve. Its superior branch ends at the exit of the eye socket, underneath the skin of the forehead. This is the trigeminal nerve branch stimulated by the Cefaly© device.

An adhesive electrode is positioned on the forehead and Cefaly© connects to this. Through the electrode, Cefaly© generates precise micro-impulses in order to stimulate the nerve endings of the trigeminal nerve.

Neurostimulation of the trigeminal nerve with Cefaly© produces a sedative effect. Regular repetition of this sedative effect helps reduce the number of attacks of migraine.

Two studies, involving 87 patients, looked at how well the procedure works, and showed the following benefits after 3 months of treatment with the device:

  • fewer days with migraine
  • fewer migraine attacks each month
  • fewer days each month with any headache
  • less severe headaches
  • fewer migraine drugs needed each month
  • most patients were very or moderately satisfied.

The studies showed that the risks were not serious and were seen in a small number of patients. They included:

  • ‘minor and reversible events’ (no further details provided) in 4% of patients
  • local pain or intolerance to pins and needles caused by the device in 2% of patients
  • skin problems in less than 1% of patients, including temporary local skin allergy, forehead skin irritation and a feeling of bruising on the forehead
  • muscle weakness and dizziness in 1 patient, which went away within 2 hours after the device was stopped.

If you want to know more about the studies, see the NICE guidance. Contact our Information Service or ask your health professional to explain anything you don’t understand.

The device can be obtained from the Cefaly© website. Cefaly© used to provide a scheme in which they accept the device back after two months and refund a proportion of the cost if daily use for two months was of no benefit. A study published by Cefaly© showed a beneficial difference after two months so users should know if the device is helpful by that time. Check with Cefaly© if this scheme is still operational before purchase.