Migraine in Electrohypersensitive Patients | NCT04845152

Studies
Migraine in Electrohypersensitive Patients

NCT04845152

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Jun 26, 2023Actual

Enrollment

317Actual

Phase

Not provided

Conditions

Headache
Migraine

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2021Actual

Primary Completion Date

Dec 1, 2021Actual

Completion Date

Jan 30, 2022Actual

First Submitted Date

Apr 10, 2021

First Submission Date that Met QC Criteria

Apr 10, 2021

First Posted Date

Apr 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2023

Last Update Posted Date

Jun 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

317Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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
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

Exclusion criteria:

- age under 18 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

An adult declaring himself electrohypersensitive

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frédéric GRECO	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006261	Headache
D008881	Migraine Disorders

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided