Expired Study
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Aurora, Colorado 80045


Purpose:

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.


Criteria:

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)


NCT ID:

NCT02342743


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Aurora, Colorado 80045
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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