Pulsed Electromagnetic Fields for Multiple Chemical Sensitivity

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

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • 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

      • 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

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
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

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

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.

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.

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

April 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

April 12, 2013

First Submitted That Met QC Criteria

April 17, 2013

First Posted (Estimate)

April 18, 2013

Study Record Updates

Last Update Posted (Estimate)

April 16, 2014

Last Update Submitted That Met QC Criteria

April 15, 2014

Last Verified

April 1, 2014

More Information

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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