Background: Migraine is included in the top-ten disabling diseases and conditions among the Western\npopulations. Non-invasive neurostimulation, including the Cefaly�® device, for the treatment of various types of pain\nis a relatively new field of interest. The aim of the present study was to explore the clinical experience with Cefaly�®\nin a cohort of migraine patients previously refractory or intolerant to topiramate prophylaxis.\nMethods: A prospective, multi-center clinical study was performed in patients diagnosed with episodic or chronic\nmigraine with a previous failure to topiramate treatment requiring prevention with Cefaly�® according to the\ntreating physicianâ��s suggestion. A 1-month period of baseline observation was followed by a 3-month period of\nobservation during the use of transcutaneous supraorbital nerve stimulation (t-SNS) with Cefaly�® as the only\npreventive treatment.\nResults: A small but statistically significant decline was shown over time in the number of days with headache (HA),\nthe number of days with HA with intensity â�¥5/10, and the number of days with use of acute medication after\n3 months (p < 0.001 for all of the three changes). Twenty-three patients (65.7%) expressed their satisfaction and intent\nto continue treatment with Cefaly�®. Compliance was higher among satisfied subjects compared to non-satisfied\nsubjects. None of the explored factors were significantly associated with the reason for the failure of topiramate.\nConclusion: Three-months of preventive treatment for episodic or chronic migraine with t-SNS proved to be an\neffective, safe and well tolerated option for the treatment of patients with migraine who were intolerant or did not\nrespond to topiramate.
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