AzTrials
AzTrials

Multiple Chemical SensitivityNCT01834781

Pulsed Electromagnetic Fields for Multiple Chemical Sensitivity

A study testing Pulsed electromagnetic fields and w/o pulsed electromagnetic fields in people with Multiple Chemical Sensitivity, run by The Danish Research Centre for Chemical Sensitivities at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Multiple Chemical Sensitivity
What is being tested?
Pulsed electromagnetic fields and w/o pulsed electromagnetic fields
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
1 siteDenmark
Study dates
Apr 2013to Mar 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • The Danish Research Centre for Chemical Sensitivities

    Gentofte Municipality, DK-2820

Other trials in Denmark

About this study

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

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.

Being tested
Pulsed electromagnetic fields, w/o pulsed electromagnetic fields
Keywords
multiple chemical sensitivity, re5 therapy, pulsed electromagnetic fields
Medical subject headings
Multiple Chemical Sensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulsed electromagnetic fieldsDevice

    Also called Re5 Independent System, Re5 therapy

  • w/o pulsed electromagnetic fieldsDevice

Study groups in NCT01834781
Study groupRoleWhat they receive
Pulsed electromagnetic fieldsActive comparatorPulsed electromagnetic fields is applied transcranially 30 minutes twice a day for 7 days a week over 6 consecutive weeks
Receives: Device: Pulsed electromagnetic fields
Wearing the inactive devicePlacebo comparatorThe inactive device is worn on the head for 30 minutes twice a day for 7 days a week over 6 consecutive weeks
Receives: Device: w/o pulsed electromagnetic fields

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups

Secondary outcomes (13)

  1. 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.

    Measured: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups

  2. 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.

    Measured: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups

  3. 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

    Measured: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups

  4. 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.

    Measured: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups

  5. 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.

    Measured: Week 6, and 2½ and 4½ month follow-ups

  6. 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.

    Measured: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups

  7. Change from baseline in anxiety (Symptom Check List-92)

    Measured: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups

  8. Change from baseline in somatization (Symptom Check List-92)

    Measured: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups

  9. 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.

    Measured: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups

  10. 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.

    Measured: Week 1, 2, 3, 4, 5, 6, and 2½ and 4½ month follow-ups

  11. 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.

    Measured: Week 6 and 4½ month follow-ups

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

    Measured: Week 6

  13. 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

    Measured: Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01834781
Sponsor's protocol ID
MCS-Re5
Status last verified
Apr 2014
First submitted
12 Apr 2013
Last updated
16 Apr 2014
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 23947742

Questions about this trial

What is this clinical trial studying?

A study testing Pulsed electromagnetic fields and w/o pulsed electromagnetic fields in people with Multiple Chemical Sensitivity, run by The Danish Research Centre for Chemical Sensitivities at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01834781, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in