Retrospective Study on the Use of CEFALY® Device During Migraine Attacks

Completed

• Conditions: Migraine

• Registration Number: NCT02616978
• Lead Sponsor: Cefaly Technology

Brief Summary

This is an Internet survey to collect data on the use of the Cefaly device to treat migraine attacks in regular Cefaly users.

Detailed Description

About 1000 CEFALY users, having the device since more than one year and having reordered electrodes in the last year, will be invited to participate to an Internet survey. This survey contains at most 8 questions, and data will be collected completely anonymously. Questions concern the use or not of the CEFALY during migraine attacks, the number of treated attacks and the number and type of acute anti-migraine drugs that were avoided thanks to the use of the CEFALY.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-19
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-11-30
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-05
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 807

Inclusion Criteria

• Subjects using Cefaly device regularly for more than a year identify by reordering of electrodes during the last year.
• History of likely episodic or chronic migraine with or without aura diagnosed by a physician

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Monthly number of acute drug intake avoided when using Cefaly to treat a migraine attack	Maximum 1 year	On average, mean number of anti-migraine acute drug intake avoided per month per patient in regular Cefaly users, based on self reported average monthly number of attacks and percentage of attacks treated successfully with the Cefaly

Secondary Outcome Measures

Name	Time	Method
Proportion of migraine attacks treated with the Cefaly device	Maximum 1 year	Percentage of migraine attacks treated with the Cefaly device by the Cefaly users
Proportion of migraine attacks for which the use of the Cefaly device generate a reduction of drug intake	Maximum 1 year	Percentage of migraine attacks treated with the Cefaly device and for which the acute anti-migraine drug intake is reduced thanks to the Cefaly
Proportion of Cefaly users that report using also the device to treat migraine attacks	Maximum 1 year	Percentage of regular Cefaly users using the device to treat attacks