Transcutaneous Supraorbital Nerve Stimulation (t-SNS) with the Cefaly® Device for Migraine Prevention: A Review of the Available Data

Franz Riederer, Sophie Penning, Jean Schoenen, Franz Riederer, Sophie Penning, Jean Schoenen

Abstract

So far, among the different non-invasive neurostimulation methods, only transcutaneous supraorbital nerve stimulation (t-SNS) with the Cefaly® (Cefaly Technology sprl, Herstal, Belgium) device has randomized controlled trial-based evidence for safety and efficacy and obtained American Food and Drug Administration approval for the prevention of episodic migraine. In a double-blinded, randomized, sham-controlled trial on 67 episodic migraine patients (mean pre-treatment migraine days/month: 6.9), the 50% responder rate after 3 months was significantly higher in the active group (38.2%) than in the sham group (12.1%); attack frequency and total headache days were also significantly reduced, but not headache severity. Acute anti-migraine drug intake was reduced by 36.7% in the active group. Statistical sub-analysis suggested that t-SNS was more effective in patients with a higher attack frequency. In a large survey on 2313 Cefaly users about safety and satisfaction only 4.3% of subjects reported side effects, all of which were minor and fully reversible, the most frequent being intolerance to the paresthesia feeling and the most severe an allergic skin reaction to the electrode gel. The efficacy/safety ratio of the Cefaly device was therefore most favorable, especially when compared to preventive anti-migraine drugs. The therapeutic efficacy of t-SNS with Cefaly with low-frequency migraine (≤5 attacks/month) was recently confirmed in an open randomized trial. No published data are available in chronic migraine. According to preliminary results of a fluorodeoxyglucose-positron emission tomography study, Cefaly might exert its effect in migraine by increasing activity in crucial areas of the limbic system and salience matrix such as orbitofrontal and anterior cingulate cortices.

Keywords: Cefaly®; External trigeminal nerve stimulation (e-TNS); Headache; Migraine; Migraine prophylaxis; Neuromodulation; Neurostimulation; Preventive therapy; Transcutaneous supraorbital nerve stimulation (t-SNS); Trigeminal nerve.

Figures

Fig. 1
Fig. 1
The electrical impulses generated by the Cefaly® device are transmitted via an electrode to excite the upper branches of the ophthalmic nerve (V1). These pictures are the property of Cefaly Technology
Fig. 2
Fig. 2
Results of the PREMICE study. Results are presented as means or means ± standard deviations where appropriate. Baseline and treatment period were compared using the Wilcoxon signed rank test for paired samples. Comparison of relative changes between verum and sham groups was assessed using the Wilcoxon rank sum test (also known as Mann–Whitney U test). P values < 0.05 are considered as significant

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