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CompletedNCT02616978Updated May 8, 2017

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

An observational study in Migraine, sponsored by Cefaly Technology. Completed. Per ClinicalTrials.gov, last updated 2017-05-08.

Sponsored by Cefaly Technology · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
807
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Migraine

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In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 807 is above the median of 130 across 299 observational studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Cefaly Technology is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

French speaking patients in Belgium, Switzerland and France, having ordered new electrodes during the last year will be identified as regular users.

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

Exclusion Criteria:

  • N/A
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
807 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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

    Time frame: Maximum 1 year

Secondary outcomes

  1. 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

    Time frame: Maximum 1 year

  2. Proportion of migraine attacks treated with the Cefaly device

    Percentage of migraine attacks treated with the Cefaly device by the Cefaly users

    Time frame: Maximum 1 year

  3. 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

    Time frame: Maximum 1 year

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Penning S, Schoenen J. A survey on migraine attack treatment with the CEFALY(R) device in regular users. Acta Neurol Belg. 2017 Jun;117(2):547-549. doi: 10.1007/s13760-017-0757-z. Epub 2017 Feb 9. No abstract available. PubMed 28185179 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02616978
Lead sponsor
Cefaly Technology
Responsible party
Sponsor
First posted
Nov 30, 2015
Start date
Nov 2015
Primary completion
Dec 2015
Completion
Dec 2015
Last update
May 8, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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