- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01834781
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
Completed
Conditions
Intervention / Treatment
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
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Gentofte, Denmark, DK-2820
- The Danish Research Centre for Chemical Sensitivities
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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 |
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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
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Other Names:
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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
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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
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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.
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Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
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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
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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.
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Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
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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
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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.
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Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
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Change from baseline in Sheehan Disability Scale
Time Frame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
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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
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Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
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Change from baseline in individual self-selected tasks
Time Frame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
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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.
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Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
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Change from baseline in noise sensitivity
Time Frame: Week 6, and 2½ and 4½ month follow-ups
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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.
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Week 6, and 2½ and 4½ month follow-ups
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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
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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.
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Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
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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
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Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
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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
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Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
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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
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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.
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Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
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Change from baseline in Perceived Stress Scale
Time Frame: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
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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.
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Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups
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Change from baseline in World Health Organization Quality Of Life Brief version
Time Frame: Week 6 and 4½ month follow-ups
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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.
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Week 6 and 4½ month follow-ups
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Change from baseline in capsaicin-induced secondary punctate hyperalgesia
Time Frame: Week 6
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Week 6
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Change from baseline in immunological markers in serum
Time Frame: Week 6
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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
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Week 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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