Clinical Trial: Clinical Experience With Transcutaneous Supraorbital Nerve Stimulation in Refractory Migraine
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
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
Brief 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.
Detailed Summary:
Migraine is ranked as the sixth most disabling condition, worldwide.Presently, medications are the mainstream of migraine management; however, preventive treatment is often far from optimal. Preventive treatment for migraine is usually considered when migraine pain is present more frequently than twice a week.
Topiramate is currently the most commonly used first-line approved preventive medication for migraine. With this being said, not all patients respond to preventive medications, due to either lack of efficacy or to adverse events. As a matter of fact, adherence to migraine preventive medications, including topiramate, may be insufficient. In a health insurance database based review, 70.2% of patients who initiated migraine prophylaxis with antiepileptics were reported to be non-adherent after 6 months. Among preventive medication choices, patients are reported to adhere best, but not optimally to topiramate, with adverse events being the most common reason for topiramate discontinuation.
On the other hand, non-invasive neurostimulation is a relatively new field of interest for the treatment of various types of pain. Clinical research in this field is active, as the recent technological advances allow for safe, convenient and ease by which to self-administer treatment sessions. Cefaly® electrically the supraorbital nerve in the forehead. The supraorbital nerve is a branch of the first trigeminal division. The trigeminovascular system has a well-known involvement in headache pain. Transcutaneous supraorbital nerve stimulation (t-SNS) with the Cefaly® (Cefaly® Technology sprl, Herstal, Belgium) device has proved to be a safe and efficient method for convenient self-delivered treatment sessions. It has received approval for the prevention of episodic migraine by the American Food and Drug Administration and
Sponsor: Corfu Headache Clinic
Current Primary Outcome: 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.
Original Primary Outcome: Same as current
Current Secondary Outcome: Patient overall satisfaction [ Time Frame: 3 months ]
Original Secondary Outcome: Same as current
Information By: Corfu Headache Clinic
Dates:
Date Received: April 13, 2017
Date Started: January 1, 2016
Date Completion:
Last Updated: April 21, 2017
Last Verified: April 2017
