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

Completed · Not applicable

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT02342743

Run by

Cefaly Technology

People needed

73

Starts

2015-02-02

Expected to finish

2017-04-11

Last updated by the study team

2019-06-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Women: Pregnant, lactating or <6 months post partum
• 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.
• For patients treated with Botox, no injection within 4 months before start of baseline or during the study.
• Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache
• A Beck Depression Inventory score of >24 at baseline
• Psychiatric disorders that could have interfered with study participation
• Intolerance to supraorbital neurostimulation that makes the treatment not applicable (test of nociceptive threshold with specific Cefaly program)

Where it is running

• University of Colorado Anschutz Medical Campus - Department of Neurology — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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