A Phase III Trial of e-TNS for the Acute Treatment of Migraine

Exclusion Criteria

• •1. Patient has difficulty distinguishing his/her migraine attacks from tension-type headaches
• •2. Patient has more than 15 headache days per month
• •3. Patient having received supraorbital nerve blocks in the prior 4 months
• •4. Patient having received Botox treatment in the prior 4 months
• •5. Modification of a migraine prophylaxis treatment in the previous 3 months
• •6. Diagnosis of other primary headache disorders, except rare (\< 4) tension-type headaches per month
• •7. Diagnosis of secondary headache disorders including Medication Overuse Headache (MOH)
• •8. Patient abusing opioids or user of recreational or illicit drugs or having had a recent history (within the last year) of drug or alcohol abuse or dependence
• •9. Implanted metallic or electronic device in the head
• •10. Cardiac pacemaker or implanted or wearable defibrillator
• •11. Patient having had a previous experience with the Cefaly® device
• •12. Migraine Aura without headache
• •13. Patient is currently participating or has participated in a study with an investigational compound or device in the last 30 days before the screening visit (Visit 1)
• •14. Patient not having the ability to use appropriately the device and/or to perform himself/herself or bear the first 20-minute stimulation session during the training test session at the study site