Pulsed Electromagnetic Fields for Multiple Chemical Sensitivity

Study Overview
=================
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.

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

Conditions
-----------------
Multiple Chemical Sensitivity

Intervention / Treatment
-----------------
* Device: Pulsed electromagnetic fields
* Device: w/o pulsed electromagnetic fields


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulsed electromagnetic fields<br>Pulsed electromagnetic fields is applied transcranially 30 minutes twice a day for 7 days a week over 6 consecutive weeks | Device: Pulsed electromagnetic fields<br> <br> * Other names: Re5 therapy;|
| Placebo Comparator: Wearing the inactive device<br>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<br> <br> |

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) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Change from baseline in anxiety (Symptom Check List-92) |  | Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups | 
| Change from baseline in somatization (Symptom Check List-92) |  | Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups | 
| 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 | 
| 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 | 
| 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 | 
| Change from baseline in capsaicin-induced secondary punctate hyperalgesia |  | Week 6 | 
| Change from baseline in immunological markers in serum | 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 | Week 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiple chemical sensitivity, re5 therapy, pulsed electromagnetic fields