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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02616978
• Other study ID #: 50214
• Status: Completed
• Phase: N/A
• First received: November 19, 2015
• Last updated: May 5, 2017
• Start date: November 2015
• Est. completion date: December 2015

Study information

• Verified date: May 2017
• Source: Cefaly Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 807
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cefaly Technology

References & Publications (1)

Penning S, Schoenen J. A survey on migraine attack treatment with the CEFALY(®) device in regular users. Acta Neurol Belg. 2017 Feb 9. doi: 10.1007/s13760-017-0757-z. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monthly number of acute drug intake avoided when using Cefaly to treat a migraine attack	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	Maximum 1 year
Secondary	Proportion of Cefaly users that report using also the device to treat migraine attacks	Percentage of regular Cefaly users using the device to treat attacks	Maximum 1 year
Secondary	Proportion of migraine attacks treated with the Cefaly device	Percentage of migraine attacks treated with the Cefaly device by the Cefaly users	Maximum 1 year
Secondary	Proportion of migraine attacks for which the use of the Cefaly device generate a reduction of drug intake	Percentage of migraine attacks treated with the Cefaly device and for which the acute anti-migraine drug intake is reduced thanks to the Cefaly	Maximum 1 year