The purpose of this pilot study is to assess the efficacy of the Cefaly device in the
treatment of chronic migraine prior to implement a control trial where the size and final
protocol will be specified thanks to the outcomes of this pilot trial.
- Patients with a history of chronic migraine 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) will be
enrolled. They are required during baseline to have ≥15 headache days with each day
consisting of ≥4 hours of continuous headache and with ≥50% of days being migraine or
probable migraine days; and ≥4 distinct headache episodes, each lasting ≥4 hours.
Both patients with or without acute medication overuse (medication overuse headache - MOH)
will be recruited
1. Women: Pregnant, lactating or <6 months post partum
2. For patients already on treatment with medications in the following classes:
antihypertensives, antidepressants, antiepileptics, no dose change of those
medications is allowed for at least 3 months before start of baseline and during the
entire study period.
3. For patients treated with Botox, no injection within 4 months before start of
baseline or during the study.
4. Diagnosis of other primary or secondary headache disorders, except of Medication
5. A Beck Depression Inventory score of >24 at baseline
6. Psychiatric disorders that could have interfered with study participation
7. Intolerance to supraorbital neurostimulation that makes the treatment not applicable
(test of nociceptive threshold with specific Cefaly program)