Acute Treatment of Migraine Using the CEFALY Device

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