Clinical Experience With Transcutaneous Supraorbital Nerve Stimulation in Patients With Refractory Migraine or With Migraine and Intolerance to Topiramate: a Prospective Exploratory Clinical Study

Migraine is ranked as the sixth most disabling condition, worldwide.Presently, medications are the mainstream of migraine management; however, preventive treatment is often far from optimal. Preventive treatment for migraine is usually considered when migraine pain is present more frequently than twice a week.

Topiramate is currently the most commonly used first-line approved preventive medication for migraine. With this being said, not all patients respond to preventive medications, due to either lack of efficacy or to adverse events. As a matter of fact, adherence to migraine preventive medications, including topiramate, may be insufficient. In a health insurance database based review, 70.2% of patients who initiated migraine prophylaxis with antiepileptics were reported to be non-adherent after 6 months. Among preventive medication choices, patients are reported to adhere best, but not optimally to topiramate, with adverse events being the most common reason for topiramate discontinuation.

On the other hand, non-invasive neurostimulation is a relatively new field of interest for the treatment of various types of pain. Clinical research in this field is active, as the recent technological advances allow for safe, convenient and ease by which to self-administer treatment sessions. Cefaly® electrically the supraorbital nerve in the forehead. The supraorbital nerve is a branch of the first trigeminal division. The trigeminovascular system has a well-known involvement in headache pain. Transcutaneous supraorbital nerve stimulation (t-SNS) with the Cefaly® (Cefaly® Technology sprl, Herstal, Belgium) device has proved to be a safe and efficient method for convenient self-delivered treatment sessions. It has received approval for the prevention of episodic migraine by the American Food and Drug Administration and by the EU, including Greece, since early 2015.

Although t-SNS use is spreading in Greece, it is not reimbursed by the social security system and in many cases it may be postponed until either a first line preventive medication fails to provide substantial relief or tolerability / safety issues ensue.

The aim of the present study was to explore and share the clinical experience with Cefaly® in a cohort of migraine patients previously refractory or intolerant to preventive treatment with topiramate, as this is a common situation in clinical practice. Additionally, we specifically explored whether the reason for the discontinuation of topiramate is correlated with the outcome of Cefaly® treatment. To the best of the authors' knowledge, no similar study has been published so far.