Clinical Experience With Transcutaneous Supraorbital Nerve Stimulation in Refractory Migraine
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|ClinicalTrials.gov Identifier: NCT03125525|
Recruitment Status : Completed
First Posted : April 24, 2017
Last Update Posted : April 24, 2017
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.
|Condition or disease||Intervention/treatment|
|Migraine||Device: Cefaly device|
|Study Type :||Observational|
|Actual Enrollment :||37 participants|
|Official Title:||Clinical Experience With Transcutaneous Supraorbital Nerve Stimulation in Patients With Refractory Migraine or With Migraine and Intolerance to Topiramate: a Prospective Exploratory Clinical Study|
|Actual Study Start Date :||January 1, 2016|
|Actual Primary Completion Date :||June 30, 2016|
|Actual Study Completion Date :||June 30, 2016|
Active treatment patients
Patients using Cefaly device on routine daily basis
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
Other Name: transcutaneous supraorbital nerve stimulation with Cefaly
- Change in headache days [ Time Frame: 4 months ]
Change in headache days, as recorded on a self-administered headache questionnaire, at 1st, 2nd and 3rd month of active treatment comparing to the baseline observation.
Linear Mixed Models were performed, with patients modelled as a random effect, time (study month), and their interaction modelled as fixed effects.
Statistical significance was set to the observed level of 5%. All statistical analyses were performed using STATA v.13.
- Patient overall satisfaction [ Time Frame: 3 months ]Patients resonse to the question "Are you satisfied with Cefaly® and wish to continue the treatment?"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125525
|Study Director:||Michail Vikelis||Meditteraneo Hospital of Athens|