HeadacheNCT04845152
Migraine in Electrohypersensitive Patients
An observational study of Headache and Migraine, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The investigators propose here by the use of the French version of the migraine disease screening questionnaire (ID Migraine ™) to study the prevalence of migraine disease in a population of electrohypersensitive patients Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 317 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2021to 30 Jan 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: An adult declaring himself electrohypersensitive
Who may be able to join
- Informed Consent
- 18 years or older at the time of informed consent
- With all these criteria :
- the perception by the subjects of various non-specific functional symptoms
- the absence of clinical and biological evidence to explain the symptoms
- the attribution by the subjects themselves of these symptoms to exposure to electromagnetic fields, which are themselves diverse
Show all 9Show fewer
- the symptoms are chronic (more than 3 months)
- the symptoms appear during an exposure to a source of electromagnetic radiation and cease after the exposure is stopped
- the symptoms are reproducible
Who cannot join
- age under 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Migraine Disease in Electrohypersensitive Patients
The investigators propose here by the use of the French version of the migraine disease screening questionnaire (ID Migraine ™) to study the prevalence of migraine disease in a population of electrohypersensitive patients
- Keywords
- Electrohypersensitivity
- Medical subject headings
- Headache, Migraine Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Possible migraine attack
With the number of positive response to the French version of the migraine disease screening questionnaire, we are looking for the patients declaring themselves electrohypersensitive if they have had headaches in the last 12 months with characteristics that could evoke a migraine attack.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start30 Apr 2021
- Primary completion1 Dec 2021
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric GRECO, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845152
- Sponsor's protocol ID
- RECHMPL21_0250
- Status last verified
- Jun 2023
- First submitted
- 10 Apr 2021
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Migraine Disease in Electrohypersensitive Patients
- ClinicalTrials.gov ID
- NCT04845152
- Acronym / sponsor ID
- RECHMPL21_0250
- Keywords
- Electrohypersensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 14 Apr 2021 (actual)
- 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.
The investigators propose here by the use of the French version of the migraine disease screening questionnaire (ID Migraine ™) to study the prevalence of migraine disease in a population of electrohypersensitive patients
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- An adult declaring himself electrohypersensitive
Key inclusion criteria (9 listed)
- Informed Consent
- 18 years or older at the time of informed consent
- the perception by the subjects of various non-specific functional symptoms
- the absence of clinical and biological evidence to explain the symptoms
- the attribution by the subjects themselves of these symptoms to exposure to electromagnetic fields, which are themselves diverse
Key exclusion criteria (1 listed)
- age under 18 years old
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
Possible migraine attack
Time frame: 12 months
With the number of positive response to the French version of the migraine disease screening questionnaire, we are looking for the patients declaring themselves electrohypersensitive if they have had headaches in the last 12 months with characteristics that could evoke a migraine attack.
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 26 Jun 2023.
- Individual participant dataSharing planned: Undecided. NC
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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.
Frédéric GRECO principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache and Migraine, run by University Hospital, Montpellier at 1 site in France.
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 9 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 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Possible migraine attack (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2023.