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Completed

NCT Number: NCT01834781

Pulsed Electromagnetic Fields for Multiple Chemical Sensitivity

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Danish Research Centre for Chemical Sensitivities

Gentofte Municipality, DK-2820, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulsed electromagnetic fields

Device

Other names: Re5 Independent System, Re5 therapy

w/o pulsed electromagnetic fields

Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. Change from baseline in capsaicin-induced secondary punctate hyperalgesia

    Time frame: Week 6

  13. 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

Sponsors and collaborators

Lead sponsor

The Danish Research Centre for Chemical Sensitivities

Other

Collaborators

  • Aage Bangs Fond

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 18, 2013
Registry last updated
Apr 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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