Evaluation of a Specialized Therapeutic Care of Patients Presenting an Intolerance Attributed to Electromagnetic Fields (IEI-CEM)

November 17, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Evaluation of a Specialized Therapeutic Care of Patients Presenting an Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields

The purpose of the study is to evaluate efficacy of a 14 months follow-up and individual medical care of electro-sensitive patients: by measurement of health status, sensitivity to electromagnetic fields exposures, and quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

110 patients suffering from Idiopathic Environmental Intolerance attributed to electromagnetic fields (IEI-EMF) are expected in this trial.

Type of trial: Interventional multicenter study, non-randomized, with measurement before and after intervention. Each patient is his own control.

Primary outcome: Efficacy of an individual medical care on electro sensitive (IEI CEM) patients evaluated from the improvement of health status, sensitivity to electromagnetic fields (EMF) exposure, and quality of life.

Scheme:

Visit 1(T0): Patients undergo a specialized medical examination: a standardized medical record is filled in. Physicians evaluate the psychological impact of IEI-EMF and a psychotherapeutic care is proposed if necessary. Patients fill in 2 self-questionaries: quality of life (SF-36) and EMF exposure sensitivity.

After the visit 1, a symptoms self-administrated questionary n°1 is completed during 7 days.

1 month after inclusions (T1), radiofrequencies (RF) are recorded by a dosimeter worn by patients for 7 days; patient fill-in the symptoms self-administrated questionary n° 2 during the same time.

Visit 2: 6 months after inclusion, analysis of symptoms and RF exposure is restituted at patient. An adapted care is proposed.

12 months after inclusion (T12), patients complete the symptoms self-administrated questionary n°3.

Visit 3: 14 months after inclusion (T14), patients have medical examination and complete the quality of life and EMF exposure sensitivity self-questionaries. Standardized medical record is filled in by physicians. Patient and physician discuss the global and comparative analysis of individual results.

Inclusion duration: 24 month; Follow-up: 14 months; Study duration: 38 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
79

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Service de Pathologie Professionnelle, Hôpital Cochin, Hôpitaux Universitaires Paris Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects who declare themselves to be intolerant to electromagnetic fields
  • Subjects over 18 years old
  • Subjects affiliated to a social security scheme
  • Subjects who signed the consent form

Exclusion Criteria:

  • Subject with a disorder of the understanding of the French language at the discretion of the investigator
  • Pregnant women,
  • Persons deprived of their liberty, persons under guardianship, and persons in emergency situations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
Patients who declare themselves to be intolerant to electromagnetic fields benefit from medical care in occupational and environmental diseases centers and from a measurement of individual electromagnetic exposures and symptoms episodes. Each patient is his own control.
Other: Individual medical Care
Individual medical care in occupational and environmental diseases centers
Other: Individual electromagnetic exposures
During 7 days, patient hold a dosimeter measuring their electromagnetic exposures for FM, TV, GSM, DECT, WIFI, TETRA and relay antenna emissions. During this week, patients notify intensity and time of their symptoms on a self-questionary

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measurement of symptoms severity
Time Frame: At 12 months after inclusion .
At month 12 months the severity of symptoms is evaluated by a self-questionary filled in during 7 days. The level of severity of each symptom occurring during a week, will be self-evaluated by the patient on the base of a 0 to 5 scale. Following the intervention we expect a reduction in the severity of symptoms described.
At 12 months after inclusion .
Measurement of symptoms frequency
Time Frame: At 12 months after inclusion
At month 12 months the symptoms frequency is evaluated by a self-questionary filled in during 7 days. Each symptom occurring during a week is reported by the patient allowing calculation of a frequency in symptoms appearance. Following the intervention we expect a reduction in the frequency of symptoms described.
At 12 months after inclusion
Sensitivity to electromagnetic fields
Time Frame: at 14 months
At visit 3 (14 months) the EMF sensitivity is evaluated by the self-questionary.
at 14 months
Measurement of symptoms frequency
Time Frame: At 1 month after inclusion
At month 1 months the symptoms frequency is evaluated by a self-questionary filled in during 7 days. Each symptom occurring during a week is reported by the patient allowing calculation of a frequency in symptoms appearance. Following the intervention we expect a reduction in the frequency of symptoms described.
At 1 month after inclusion
Measurement of symptoms severity
Time Frame: At 1 month after inclusion
At month 1 month the severity of symptoms is evaluated by a self-questionary filled in during 7 days. The level of severity of each symptom occurring during a week, will be self-evaluated by the patient on the base of a 0 to 5 scale. Following the intervention we expect a reduction in the severity of symptoms described.
At 1 month after inclusion
Sensitivity to electromagnetic fields
Time Frame: at day 0
At visit 1 (day 0), the EMF sensitivity is evaluated by the self-questionary.
at day 0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of life evaluation
Time Frame: at 14 months.
At visit 3 (14 months), the quality of life is evaluated by the self-questionary (SF-36)
at 14 months.
Compliance to the study design
Time Frame: At each Visit (Day 0, Month 1, Month 6 and month 14)
At each Visit (Day 0, Month 1, Month 6 and month 14)
Quality of life evaluation
Time Frame: day 0
At visit1 (day 0), the quality of life is evaluated by the self-questionary (SF-36)
day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
URC-CIC Paris Descartes Necker Cochin
ANSES, France
INERIS, Verneuil-En-Halatte, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Lynda BENSEFA-COLAS, MD, Service de Pathologie Professionnelle, Hopital Cochin, AP-HP, Paris
  • Study Director: Rene de SEZE, MD, INERIS (Institut National de l'EnviRonnement Industriel et des RisqueS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P100120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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