MigraineNCT02616978
Retrospective Study on the Use of CEFALY® Device During Migraine Attacks
An observational study of Migraine, run by Cefaly Technology.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Migraine
- How many people
- 807 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: French speaking patients in Belgium, Switzerland and France, having ordered new electrodes during the last year will be identified as regular users.
Who may be able to join
- 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
Who cannot join
- N/A
About this study
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.
- Conditions
- Migraine
- Medical subject headings
- Migraine Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Maximum 1 year
Secondary outcomes (3)
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
Measured: Maximum 1 year
Proportion of migraine attacks treated with the Cefaly device
Percentage of migraine attacks treated with the Cefaly device by the Cefaly users
Measured: Maximum 1 year
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
Measured: Maximum 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 807 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cefaly Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616978
- Sponsor's protocol ID
- 50214
- Status last verified
- May 2017
- First submitted
- 19 Nov 2015
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on the Use of CEFALY® Device During Migraine Attacks
- ClinicalTrials.gov ID
- NCT02616978
- Acronym / sponsor ID
- 50214
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 807 participants (actual)
- Lead sponsor
- Cefaly TechnologyIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- French speaking patients in Belgium, Switzerland and France, having ordered new electrodes during the last year will be identified as regular users.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Monthly number of acute drug intake avoided when using Cefaly to treat a migraine attack
Time frame: 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
3 secondary outcomes
Proportion of Cefaly users that report using also the device to treat migraine attacks
Time frame: Maximum 1 year
Proportion of migraine attacks treated with the Cefaly device
Time frame: Maximum 1 year
Proportion of migraine attacks for which the use of the Cefaly device generate a reduction of drug intake
Time frame: Maximum 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Results publication: PubMed 28185179Penning 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.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Cefaly Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monthly number of acute drug intake avoided when using Cefaly to treat a migraine attack (time frame: Maximum 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02616978, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.