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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

Tracking Information
First Submitted Date  ICMJE April 12, 2013
First Posted Date  ICMJE April 18, 2013
Last Update Posted Date April 16, 2014
Study Start Date  ICMJE April 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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 ]
  • 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 ]
  • 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.
  • 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.
  • 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.
  • Change from baseline in capsaicin-induced secondary punctate hyperalgesia [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pulsed Electromagnetic Fields for Multiple Chemical Sensitivity
Official Title  ICMJE Transcranial Pulsed Electromagnetic Fields for Multiple Chemical Sensitivity: a Study Protocol for a Randomized, Double-blind, Placebo-controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Chemical Sensitivity
Intervention  ICMJE
  • Device: Pulsed electromagnetic fields
    Other Names:
    • Re5 Independent System
    • Re5 therapy
  • Device: w/o pulsed electromagnetic fields
Study Arms  ICMJE
  • 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
    Intervention: Device: Pulsed electromagnetic fields
  • 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
    Intervention: Device: w/o pulsed electromagnetic fields
Publications * Tran MT, Skovbjerg S, Arendt-Nielsen L, Christensen KB, Elberling J. Transcranial pulsed electromagnetic fields for multiple chemical sensitivity: study protocol for a randomized, double-blind, placebo-controlled trial. Trials. 2013 Aug 16;14:256. doi: 10.1186/1745-6215-14-256.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2014)
39
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2013)
40
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01834781
Other Study ID Numbers  ICMJE MCS-Re5
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Danish Research Centre for Chemical Sensitivities
Study Sponsor  ICMJE The Danish Research Centre for Chemical Sensitivities
Collaborators  ICMJE Aage Bangs Fond
Investigators  ICMJE Not Provided
PRS Account The Danish Research Centre for Chemical Sensitivities
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP