Study of Wireless Nerve Stimulation in the Treatment of Chronic Migraine

Inclusion Criteria

• •Subject is ≥ 18 years but less than 65 years of age at time of informed consent;
• •Subject who developed chronic migraine before the age of 60 years old;
• •Subjects have been diagnosed with chronic migraine according to the International Classification of Headache Disorders-3 (ICHD-3) (2013) criteria;
• •No medication overuse and not attributed to another causative disorder;
• •Subjects have chronic migraine for at least 6 months prior to enrollment;
• •Are refractory to conventional pharmacological chronic migraine treatments as defined by the failure to respond, or the intolerance, to at least 3 prophylaxis therapies (of which one is topiramate if not contraindicated) as determined by the investigator;
• •Based on the medical opinion of the Principal Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject;
• •Subject is willing to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements;
• •Based on the opinion of the Principal Investigator, subject is willing and able to operate the patient programmer, recharging equipment, and electronic diary equipment, and has the ability to undergo study assessments and provide accurate responses;
• •Based on the opinion of the implanter, subject is a good surgical candidate for the implant procedure;
• •Subject is male or non-pregnant female. If female of child-bearing potential, must have a negative pregnancy test at baseline visit, and if sexually active, must be using a medically acceptable method of contraception for the duration of their study participation; Subject is deemed to be neuropsychosocially appropriate for implantation therapies based of the assessment of a Clinical Psychologist, using face-to-face encounters and the psychological testing described in the measures.