A Feasibility Clinical Trial to Evaluate High Frequency Spinal Cord Stimulation for the Treatment of Patients With Chronic Migraine

The purpose of this study is to assess short- and long-term safety, tolerability and efficacy of cervical High Frequency Spinal Cord Stimulation (HF-SCS) in patients suffering from chronic migraine refractory to conventional medical therapy.

Inclusion Criteria: * An adult between the age of 18 and 65 * Capable of providing informed consent * A diagnosis of chronic (\>15 or more headache-days per 4 week period for more than 3 months, with an headache-day being defined as a day with an attack lasting a minimum of 4 hours) migraine refractory to conventional medical treatment (has failed at least 2 preventive and 2 abortive drugs) as per the ICHD-II guidelines. * On optimal and stable preventive headache pharmacological migraine therapy for at least 2 months * Failed treatment with Onabotulinumtoxin A for 12 months * Able to comply with the requirements of the study visits and self-assessment questionnaires Able to provide informed consent and willing to comply with study procedures Exclusion Criteria: * • medication-overuse headache * Had treatment with Onabotulinumtoxin A in the last 3 months * An already implanted active medical device * A contraindication to the cervical placement of SCS lead * A life expectancy of less than 1 year * A female of child bearing potential who is pregnant/lactating or not using adequate birth control * Beck Depression Inventory score of \>24 * Evidence of an active disruptive psychological/psychiatric disorder or other known condition significant enough to impact perception of pain (e.g. fibromyalgia), compliance of intervention and/or ability to evaluate treatment outcome as determined by the Investigator * Addiction to any of the following: illicit drugs, alcohol (5 or more drinks/day), and/or medication * Bleeding diathesis such as coagulopathy or thrombocytopenia * Immuno-compromised and at risk for infection * Diabetic which is not under control as determined by the Investigator * Unresolved issue of secondary gain * Inability to manage the technical demands of the SCS equipment * Currently participating in a randomized clinical trial with an active treatment arm or planned to be enrolled in another clinical trial