Pulsed Electromagnetic Fields for Multiple Chemical Sensitivity

Multiple Chemical Sensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01834781
• Other study ID #: MCS-Re5
• Status: Completed
• Phase: N/A
• First received: April 12, 2013
• Last updated: April 15, 2014
• Start date: April 2013
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: The Danish Research Centre for Chemical Sensitivities
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Chemical Sensitivity

Intervention

Device:
• Pulsed electromagnetic fields

• w/o pulsed electromagnetic fields

Locations

Country	Name	City	State
Denmark	The Danish Research Centre for Chemical Sensitivities	Gentofte

Sponsors (2)

Lead Sponsor	Collaborator
The Danish Research Centre for Chemical Sensitivities	Aage Bangs Fond

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Life Impact Scale (Quick Environmental Exposure and Sensitivity Inventory)	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	No
Secondary	Change from baseline in Symptom Severity Scale (Quick Environmental Exposure and Sensitivity Inventory)	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	No
Secondary	Change from baseline in Chemical Intolerance Scale (Quick Environmental Exposure and Sensitivity Inventory)	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	No
Secondary	Change from baseline in Sheehan Disability Scale	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	No
Secondary	Change from baseline in individual self-selected tasks	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	No
Secondary	Change from baseline in noise sensitivity	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	No
Secondary	Change from baseline in depression (Symptom Check List-92)	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	No
Secondary	Change from baseline in anxiety (Symptom Check List-92)		Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups	No
Secondary	Change from baseline in somatization (Symptom Check List-92)		Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups	No
Secondary	Change from baseline in 6-item Hamiltons Depression Scale	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	No
Secondary	Change from baseline in Perceived Stress Scale	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	No
Secondary	Change from baseline in World Health Organization Quality Of Life Brief version	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	No
Secondary	Change from baseline in capsaicin-induced secondary punctate hyperalgesia		Week 6	No
Secondary	Change from baseline in immunological markers in serum	IL-1ß, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IL-17, IL-21, IL-22, IL-23, TNFa, IFN?	Week 6	No