Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches

Inclusion Criteria

• Age ≥18 years.
• Subject has onset of migraine headache occurring before age 60.
• Subject has been diagnosed with migraine headache with or without aura, according to the 2004 IHS criteria 1.1 and 1.2.
• Subject reports a HIT-6 score of >56, a MIDAS score of >20 and/or a failure of adequate and appropriate previous migraine treatment.
• Subject has carried the diagnosis of migraine for at least 6 months prior to enrollment.
• Subject has had at least three migraine headache attacks per month.
• Subject has had at least three headache days (migraine or non-migraine) per month and maintains this requirement during the baseline period on diary.
• Subject is able to distinguish migraine headache attacks as discrete from other headaches (i.e., tension-type headaches).
• Subject has the ability to read, comprehend and legibly and reliably record information as required by the protocol.
• Subject is able to provide written informed consent prior to participation in the study.
• Subject agrees to not participate in supplemental or alternative therapy during the baseline or treatment phases of the clinical study. This includes: acupuncture, spinal manipulation, TENS, and magnetic field treatments.
• Subject agrees to maintain current preventative headache medication regimens (no change in type, frequency, or dose) from baseline screening visit to the end of the Phase 2 treatment phase.

Exclusion Criteria

• Subject currently has Medication Overuse Headache (MOH) in the judgment of the investigator or by ICHD-II criteria.
• Subject has a history of headaches days ≥ 15 per month.
• Subject has a history of trigeminal autonomic cephalalgias.
• Subject has any medical condition or disorder that:
• Is considered to be clinically significant and may pose a safety concern
• Could interfere with the accurate assessment of safety or efficacy
• Could potentially affect a subject's safety or study outcome.
• Subject has had a major infection or surgery in the past month.
• Subject has undergone facial surgery in the area of sphenopalatine ganglia for cosmetic, corrective, therapeutic, or traumatic reasons.
• Subject has been treated with radiation to the face.
• Subject was diagnosed with any major infectious processes, primary or secondary malignancies involving the face that have been active or required treatment in the past six (6) months.
• Subject currently meets criteria as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) for an active major depressive episode or for active significant psychiatric disorders, including dementia, uncontrolled general anxiety disorder, psychotic disorders or uncontrolled bipolar disorder. Exclusion criteria include: suicidality, active psychosis, untreated severe depression and/ or anxiety disorder, litigation, addiction, homicidal ideation, significant Axis II disorders and untreated sleep disorder.
• Subject currently has clinically significant drug or alcohol abuse as defined by DSM-IV-TR or is unable to refrain from substance abuse throughout the study.
• Subject is currently participating or has participated in the last month in another clinical study in which the subject has, is, or will be exposed to an investigational or non-investigational drug or device.
• Subject is felt to be at risk of non-compliance (e.g. for completing the diary or maintaining a stable headache medicine regimen) in the investigator's opinion.
• Subject is woman of childbearing age who is pregnant, nursing, or not using contraception.
• Subject has had previous radio-frequency ablation of the SPG.
• Subject has had blocks of the SPG in last 3 months.
• Subject has undergone botulinum toxin injections of the head and/or neck in the last 3 months.
• Subject has an implantable stimulator or any implanted devices in the head and/or neck.
• Subject has H/O bleeding disorders or coagulopathy, or is on anticoagulation, antiplatelet, o