Pulsed Electromagnetic Fields for Multiple Chemical Sensitivity

April 15, 2014 updated by: The Danish Research Centre for Chemical Sensitivities

Transcranial Pulsed Electromagnetic Fields for Multiple Chemical Sensitivity: a Study Protocol for a Randomized, Double-blind, Placebo-controlled Trial

The purpose of this study is to determine whether pulsed electromagnetic fields(PEMF) is effective in the treatment of multiple chemical sensitivity in terms of life impact, symptoms, psychological distress, markers of central sensitization and the immune system, 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.

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.
39

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

  • Denmark
      • Gentofte, Denmark, DK-2820
        • The Danish Research Centre for Chemical Sensitivities

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Lacour's criteria for multiple chemical sensitivity
  • Lifestyle or functional impairments that score ≥ 35 on the Life Impact scale of the Quick Environmental Exposure and Sensitivity Inventory
  • Signed informed consent

Exclusion Criteria:

  • previous PEMF therapy
  • psychosis or a comparable disorder
  • epilepsy
  • cerebral tumours
  • leukaemia or malignancies in the head or neck region
  • having a pacemaker or other active implants
  • pregnancy or nursing
  • unreliable contraception
  • drug or alcohol abuse
  • a pending application or intentions to apply for early retirement
  • initiation of pharmacological treatment which have not steadied
  • participation in another research study

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

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.
Active Comparator: Pulsed electromagnetic fields
Pulsed electromagnetic fields is applied transcranially 30 minutes twice a day for 7 days a week over 6 consecutive weeks
Device: Pulsed electromagnetic fields
Other Names:
  • Re5 Independent System
  • Re5 therapy
Placebo Comparator: Wearing the inactive device
The inactive device is worn on the head for 30 minutes twice a day for 7 days a week over 6 consecutive weeks
Device: w/o pulsed electromagnetic fields

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
Change from baseline in Life Impact Scale (Quick Environmental Exposure and Sensitivity Inventory)
Time Frame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
The Life Impact Scale is part of the Quick Environmental Exposure and Sensitivity Inventory (QEESI). The QEESI consists of five scales measuring different domains related to chemical sensitivities, i.e. commonly reported symptoms, chemical (inhalant) intolerances, other intolerances, life impact attributed to chemical intolerances, and on-going exposures from routinely used products (Masking Index). The Life Impact Scale consists of 10 items, where responses are rated on an 11 point scale ranging from "not at all a problem" (0) to "disabling symptoms" (10)), resulting in a score range from 0 to 100.
Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups

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
Change from baseline in Symptom Severity Scale (Quick Environmental Exposure and Sensitivity Inventory)
Time Frame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
The Symptom severity scale from the QEESI consist of ten items where responses are rated on an eleven point scale ranging from "not at all a problem" (0) to "disabling symptoms" (10), resulting in a score range from 0 to 100.
Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Change from baseline in Chemical Intolerance Scale (Quick Environmental Exposure and Sensitivity Inventory)
Time Frame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
The Chemical Intolerance scale from the QEESI consist of ten items where responses are rated on an eleven point scale ranging from "not at all a problem" (0) to "disabling symptoms" (10), resulting in a score range from 0 to 100.
Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Change from baseline in Sheehan Disability Scale
Time Frame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
The Sheehan Disability Scale (SDS) is widely used in psychiatry, but has also been applied to many other chronic medical illnesses. It uses visuo-spatial, numeric and descriptive anchors to measure impaired functioning in three domains: work, social life and family life. The scale generates four disability scores, one for each domain and a total score by adding up the three individual domain scores
Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Change from baseline in individual self-selected tasks
Time Frame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
In addition to the Life Impact scale used as the primary outcome measure, the participants will need to select three tasks in the areas of work, social life and family life, which are impaired by MCS at baseline. The degree of impairment associated with each task is scored on a scale from 0-10 with visuo-spatial, numeric and descriptive anchors similar to SDS.
Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Change from baseline in noise sensitivity
Time Frame: Week 6, and 2½ and 4½ month follow-ups
To measure the participants' sensitivity to noise, they will be asked to grade their responses to 10 different noises (e.g. drone of a machine, stroke of a hammer, rustling of paper) on a 5-point Likert scale.
Week 6, and 2½ and 4½ month follow-ups
Change from baseline in depression (Symptom Check List-92)
Time Frame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
The Symptom Checklist 92 (SCL-92) subscales for depression, anxiety and somatization will be included. These subscales comprise 35 items on which responses are rated on a 5-point Likert scale ranging from not at all to very much.
Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Change from baseline in anxiety (Symptom Check List-92)
Time Frame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Change from baseline in somatization (Symptom Check List-92)
Time Frame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Change from baseline in 6-item Hamiltons Depression Scale
Time Frame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
The 6-item Hamilton Depression Rating Scale (HAM-D6) is a short self-administered measure of depression. The scale has been shown to be as sensitive as the more widely used 17-item Hamilton Depression Rating Scale (HAM-D17) to measure antidepressive treatment effects.
Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Change from baseline in Perceived Stress Scale
Time Frame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
The short version of the Perceived Stress Scale (PSS-10) consists of 10 questions and measures the self-perception of stress by grading how different life situations are perceived. The PSS-10 has been shown to be a valid and reliable measure of perceived stress.
Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
Change from baseline in World Health Organization Quality Of Life Brief version
Time Frame: Week 6 and 4½ month follow-ups
The brief version of World Health Organization Quality Of Life (WHOQOL-BREF) is a short multidimensional questionnaire, which measures health-related quality of life. The scale consists of four domains: physical health, psychological well-being, social relationships and environment.
Week 6 and 4½ month follow-ups
Change from baseline in capsaicin-induced secondary punctate hyperalgesia
Time Frame: Week 6
Week 6
Change from baseline in immunological markers in serum
Time Frame: Week 6
IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IL-17, IL-21, IL-22, IL-23, TNFα, IFNγ
Week 6

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.
The Danish Research Centre for Chemical Sensitivities

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.
Aage Bangs Fond

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.

General Publications

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

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.
April 1, 2013

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.
March 1, 2014

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.
March 1, 2014

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 12, 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.
April 17, 2013

First Posted (Estimate)

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.
April 18, 2013

Study Record Updates

Last Update Posted (Estimate)

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.
April 16, 2014

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.
April 15, 2014

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.
April 1, 2014

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.
  • MCS-Re5

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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