The Mitigator–TNSTM is a transcutaneous neuromodulation medical device that also targets the trigeminal nerve at the supraorbital branch (above the eyebrows).  Transcutaneous supraorbital nerve stimulation (t-SNS) randomized controlled trials have shown both safety and efficacy and obtained the American Food and Drug Administration approval for the prevention and treatment 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 users of a t-SNS device 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 this treatment device was therefore most favorable, especially when compared to preventive anti-migraine drugs. 

The therapeutic efficacy of t-SNS with low-frequency migraine (≤5 attacks/month) was recently confirmed in an open randomized trial.   An FDG-PET study showed that this form of therapy might exert its effect in migraine by increasing activity in crucial areas that modulate pain such as the orbitofrontal and anterior cingulate.The Mitigator–TNSTM can be used daily for approximately 15 minutes for the prevention of migraines and during a migraine.  This form of treatment has been approved by the FDA for both prevention and treatment of acute migraine.   The Mitigator–TNSTM is pending clearance.

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