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

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


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.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Biomedical Research
  • Chronic Disease
  • Fructose / analogs & derivatives
  • Fructose / therapeutic use
  • Headache / therapy
  • Humans
  • Middle Aged
  • Migraine Disorders / therapy*
  • Neuroprotective Agents / therapeutic use
  • Pain
  • Patient Compliance
  • Prospective Studies
  • Topiramate
  • Transcutaneous Electric Nerve Stimulation / instrumentation*
  • Treatment Failure
  • Treatment Outcome
  • Young Adult


  • Neuroprotective Agents
  • Topiramate
  • Fructose

Associated data