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Pulsed Electromagnetic Fields for Multiple Chemical Sensitivity

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ClinicalTrials.gov Identifier: NCT01834781
Recruitment Status : Completed
First Posted : April 18, 2013
Last Update Posted : April 16, 2014
Sponsor:
Collaborator:
Aage Bangs Fond
Information provided by (Responsible Party):
The Danish Research Centre for Chemical Sensitivities

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Chemical Sensitivity Device: Pulsed electromagnetic fields Device: w/o pulsed electromagnetic fields Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Pulsed Electromagnetic Fields for Multiple Chemical Sensitivity: a Study Protocol for a Randomized, Double-blind, Placebo-controlled Trial
Study Start Date : April 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


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
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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834781


Locations
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Denmark
The Danish Research Centre for Chemical Sensitivities
Gentofte, Denmark, DK-2820
Sponsors and Collaborators
The Danish Research Centre for Chemical Sensitivities
Aage Bangs Fond
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Danish Research Centre for Chemical Sensitivities
ClinicalTrials.gov Identifier: NCT01834781    
Other Study ID Numbers: MCS-Re5
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: April 16, 2014
Last Verified: April 2014
Keywords provided by The Danish Research Centre for Chemical Sensitivities:
multiple chemical sensitivity, re5 therapy, pulsed electromagnetic fields
Additional relevant MeSH terms:
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Hypersensitivity
Multiple Chemical Sensitivity
Immune System Diseases
Environmental Illness
Disorders of Environmental Origin