A Randomized, Double-blind Clinical Investigation to Evaluate the Use of the Relievion™ Device in Treating Migraine.

A Prospective, Randomized, Double-blind, Parallel-group, Sham Controlled Single-center Pivotal Clinical Investigation to Evaluate the Clinical Safety and Performance of Self-administered Home-use Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation Device (Relievion™) in Treating Migraine.

This study will evaluate the clinical performance and safety of a self-administered abortive treatment for migraine headache using combined occipital and supraorbital transcutaneous nerve stimulator (Neurolief device, Relievion™).

Inclusion Criteria:

• History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD-III (International Classification of Headache Disorders) beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction).
• Capable of cooperating with the study protocol and to sign an informed consent.

Exclusion Criteria:

• Patients having received Botox treatment in the head region in the prior 4 months.
• Patients having received supraorbital or occipital nerve blocks in the prior 4 months.
• History of Medication Overuse Headache.
• Patients using opioid medication.
• Allodynia: intolerance to supraorbital and/or occipital neurostimulation (allodynia) that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 3 minutes of neurostimulation).
• Implanted metal or electrical devices in the head (not including dental implants).
• Patient having had a previous experience with the Relievion™ device.
• Patients who have concomitant epilepsy.
• History of neurosurgical interventions.
• Patients with implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
• History of drug abuse or alcoholism.
• Participation in current clinical study or participated in a clinical study within 3 months prior to this study.
• Skin lesion or inflammation at the region of the stimulating electrodes.
• Personality or somatoform disorder.
• Pregnancy or Lactation.
• Women of reproductive age not using efficient contraceptive method.
• History of cerebrovascular event.
• Subjects with recent brain or facial trauma (occurred less than 3 months prior to this study).