Open-trial on the Prevention of Chronic Migraines With the CEFALY Device

Open-trial on the Prevention of Chronic Migraines With the CEFALY Device

The main objective of this study was to assess the safety and efficacy of the Cefaly® e-TNS device as a prophylactic treatment of chronic migraine in adult patients.

The purpose of this pilot study was to assess the safety and efficacy of the Cefaly® e-TNS device in the prophylactic treatment of chronic migraine in adult patients prior to implement a control trial where the size and final protocol will be specified thanks to the outcomes of this pilot trial.

Inclusion Criteria:

• 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

Exclusion Criteria:

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 Overuse Headache
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)