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

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).