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Aurora, Colorado 80045


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.


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)



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Aurora, Colorado 80045
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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