Acute Treatment of Migraine With e-TNS

Multi-center, Double-blind, Randomized, Sham-controlled Trial on the Acute Treatment of Migraine With the Cefaly® Device

The main objective of this study is to assess the efficacy of the Cefaly® device as an acute treatment of migraine attack in adult patients. The patients will be applied either an active or placebo external neurostimulation for 1 hour during a migraine attack, and will report the pain on a visual analog scale before and after the treatment.

Inclusion Criteria:

• History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction)
• Having a migraine attack lasting at least 3 hours
• Migraine pain intensity stabilized for at least 1 hour
• Frontal, retro-, or peri- orbital headache.

Exclusion Criteria:

• Pregnant women
• Patients having received Botox treatment in the prior 4 months
• Patients having received supraorbital nerve blocks in the prior 4 months
• Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache
• Patients with only temporal or occipital headache
• Patients using opioid medication
• Patients having taken abortive migraine medication in the prior 3 hours
• Allodynia: intolerance to supraorbital neurostimulation (allodynia) that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 5 minutes of neurostimulation).
• Implanted metal or electrical devices in the head
• Cardiac pacemaker or implanted or wearable defibrillator
• Patient having had a previous experience with Cefaly®