Transcutaneous supraorbital neurostimulation in "de novo" patients with migraine without aura: the first Italian experience

Abstract

Background: Transcutaneous supraorbital neurostimulation (tSNS) has been recently found superior to sham stimulation for episodic migraine prevention in a randomized trial. We evaluated both the safety and efficacy of a brief period of tSNS in a group of patients with migraine without aura (MwoA).

Methods: We enrolled 24 consecutive patients with MwoA experiencing a low frequency of attacks, which had never taken migraine preventive drugs in the course of their life. Patients performed a high frequency tSNS and were considered "compliant" if they used the tSNS for ≥ 2/3 of the total time expected. For this reason, four patients were excluded from the final statistical analysis. Primary outcome measures were the reduction migraine attacks and migraine days per month (p < 0.05). Furthermore, we evaluated the percentage of patients having at least 50% reduction of monthly migraine attacks and migraine days. Secondary outcome measures were the reduction of headache severity during migraine attacks and HIT-6 (Headache Impact Test) rating as well as in monthly intake of rescue medication (p < 0.05). Finally, compliance and satisfaction to treatment and potential adverse effects related to tSNS have been evaluated.

Results: Between run-in and second month of tSNS treatment, both primary and secondary endpoints were met. Indeed, we observed a statistically significant decrease in the frequency of migraine attacks (p < 0.001) and migraine days (p < 0.001) per month. We also demonstrated at least 50% reduction of monthly migraine attacks and migraine days in respectively 81 and 75% of patients. Furthermore, a statistically significant reduction in average of pain intensity during migraine attacks (p = 0.002) and HIT-6 rating (p < 0.001) and intake of rescue medication (p < 0.001) has been shown. All patients showed good compliance levels and no relevant adverse events.

Conclusion: In patients experiencing a low frequency of attacks, significant improvements in multiple migraine severity parameters were observed following a brief period of high frequency tSNS. Therefore, tSNS may be considered a valid option for the preventive treatment of migraine attacks in patients who cannot or are not willing to take daily medications, or in whom low migraine frequency and/or intensity would not require pharmacological preventive therapies.

Fig. 1

Significant differences in migraine attacks (p < 0.001) and migraine days (p < 0.001) between run-in and 60-days of treatment

Fig. 2

Percentage of patients having at least 50 % reduction of monthly migraine attacks and migraine days between run-in and 60-days of treatment

Fig. 3

Significant reduction in a mean headache severity during migraine attacks (p = 0.002); b HIT-6 questionnaire rating (p < 0.001) and c monthly intake of total rescue medication intake (p < 0.001), NSAID (including acetaminophen) (p = 0.02), and triptans intake (p = 0.04)