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BMC Neurol. 2017 May 18;17(1):97. doi: 10.1186/s12883-017-0869-3.

Clinical experience with transcutaneous supraorbital nerve stimulation in patients with refractory migraine or with migraine and intolerance to topiramate: a prospective exploratory clinical study.

Author information

1
Mediterraneo Hospital, Headache Clinic, Glyfada, Greece.
2
Glyfada Headache Clinic, Glyfada, Greece.
3
Headache Outpatient Clinic, 1st Department of Neurology, National and Kapodistrian University of Athens, Athens, Greece.
4
Geniki Kliniki Euromedica, Department of Neurology, Thessaloniki, Greece.
5
Corfu Headache Clinic, 13, Mitropolitou Methodiou str, 49100, Corfu, Greece. kcspigos@gmail.com.

Abstract

BACKGROUND:

Migraine is included in the top-ten disabling diseases and conditions among the Western populations. Non-invasive neurostimulation, including the Cefaly® device, for the treatment of various types of pain is a relatively new field of interest. The aim of the present study was to explore the clinical experience with Cefaly® in a cohort of migraine patients previously refractory or intolerant to topiramate prophylaxis.

METHODS:

A prospective, multi-center clinical study was performed in patients diagnosed with episodic or chronic migraine with a previous failure to topiramate treatment requiring prevention with Cefaly® according to the treating physician's suggestion. A 1-month period of baseline observation was followed by a 3-month period of observation during the use of transcutaneous supraorbital nerve stimulation (t-SNS) with Cefaly® as the only preventive treatment.

RESULTS:

A small but statistically significant decline was shown over time in the number of days with headache (HA), the number of days with HA with intensity ≥5/10, and the number of days with use of acute medication after 3 months (p < 0.001 for all of the three changes). Twenty-three patients (65.7%) expressed their satisfaction and intent to continue treatment with Cefaly®. Compliance was higher among satisfied subjects compared to non-satisfied subjects. None of the explored factors were significantly associated with the reason for the failure of topiramate.

CONCLUSION:

Three-months of preventive treatment for episodic or chronic migraine with t-SNS proved to be an effective, safe and well tolerated option for the treatment of patients with migraine who were intolerant or did not respond to topiramate.

TRIAL REGISTRATION:

ClinicalTrials NCT03125525 . Registered 21 April 2017.

PMID:
28521762
PMCID:
PMC5437420
DOI:
10.1186/s12883-017-0869-3
[Indexed for MEDLINE]
Free PMC Article

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