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Clinical Experience With Transcutaneous Supraorbital Nerve Stimulation in Refractory Migraine

NCT03125525 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 37

Last updated 2017-04-24

No results posted yet for this study

Summary

Migraine is included in the top-ten disabling diseases and conditions among the Western populations. Non-invasive neurostimulation (t-SMS), 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 non-tolerant to topiramate prophylaxis.

Patients were followed prospectively after having been diagnosed with episodic or chronic migraine with a previous failure to topiramate treatment and having consented to receive preventive treatment with Cefaly® according to their treating physician's suggestion. A 1-month period of baseline observation was followed by a 3-month period of active treatment with transcutaneous supraorbital nerve stimulation (t-SNS) with Cefaly® as the only preventive treatment.

Conditions

Interventions

DEVICE

Cefaly device

Use of Cefaly based upon the protocol of the approval study of the device, in which it is used once every day on the migraine prevention program

Sponsors & Collaborators

  • Corfu Headache Clinic

    lead OTHER

Principal Investigators

  • Michail Vikelis · Meditteraneo Hospital of Athens

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2016-06-30
Completion
2016-06-30
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03125525 on ClinicalTrials.gov