Clinical study to determine the responder rate of the TheraNova Migraine Treatment System to that of a sham control treatment.

Inclusion Criteria:

• 18-100 years, inclusive
• Diagnosis of episodic migraine with and without aura per International Headache Society diagnostic criteria
• 4-14 migraine days per month
• Ability to provide informed consent
• Demonstrates no contraindication to the use of electrical nerve stimulation
• Capable and willing to follow all study-related procedures

Exclusion Criteria:

• Currently pregnant or breastfeeding, pregnant within the past 6 months or intends to become pregnant during the enrollment period
• Diagnosis of chronic migraine or other forms of primary or secondary headache disorders, including medication overuse headache per International Headache Society diagnostic criteria
• Any medical condition that would, in the opinion of the investigator, make the subject ineligible
• Has received botulinum toxin injections within the past 3 months
• Is currently implanted with an electrical and/or neurostimulator devic, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, sacral stimulator, bone growth stimulator, or cochlear implant
• Use of investigational drug/device therapy within the past 4 weeks
• Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination (including bleeding disorders, anticoagulant medications and peripheral neuropathy)
• No changes in preventive medications (or other medications determined to potentially interfere with the study) in the previous 30 days and no intent to change it during the study