Acute Treatment of Migraine Using the CEFALY Device
Acute Treatment of Migraine Using the CEFALY Device
The purpose of this study is to investigate the efficacy of e-TNS with the Cefaly® device as
 an acute treatment for a migraine attack. This open clinical trial will study the acute
 treatment of migraine using the Cefaly® device, prior to development of a sham-controlled
 trial.
Inclusion Criteria:

 -  Patient with a history of episodic or chronic migraine with or without aura, meeting
 the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine (1), with
 the exception of ''complicated migraine'' (i.e., hemiplegic migraine, migraine with
 brainstem aura, ophthalmoplegic migraine- recurrent painful ophthalmoplegic
 neuropathy, migrainous infarction)

 -  The patient must be experiencing a migraine attack lasting for at least 3 hours, with
 pain intensity stabilized for at least 1 hour. The location of the headache should be
 frontal, retro- or peri- orbital, on one or either side.

 Exclusion Criteria:

 -  Pregnant women

 -  Patients having received treatment with onabotulinum toxin (e.g., Botox, Dysport,
 Xeomin) to the head 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 headaches

 -  Patients taking opioid medications

 -  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 while the neurostimulation has
 already started).

 -  Implanted metal or electrical devices in the head

 -  Cardiac pacemaker or implanted or wearable defibrillator