Pulsed Electromagnetic Fields for Multiple Chemical Sensitivity

NCT ID: NCT01834781

Last Updated: 2014-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-03-31

Brief Summary

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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

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Conditions

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Multiple Chemical Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pulsed electromagnetic fields

Pulsed electromagnetic fields is applied transcranially 30 minutes twice a day for 7 days a week over 6 consecutive weeks

Group Type ACTIVE_COMPARATOR

Pulsed electromagnetic fields

Intervention Type DEVICE

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

Group Type PLACEBO_COMPARATOR

w/o pulsed electromagnetic fields

Intervention Type DEVICE

Interventions

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Pulsed electromagnetic fields

Intervention Type DEVICE

w/o pulsed electromagnetic fields

Intervention Type DEVICE

Other Intervention Names

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Re5 Independent System Re5 therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aage Bangs Fond

OTHER

Sponsor Role collaborator

The Danish Research Centre for Chemical Sensitivities

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Danish Research Centre for Chemical Sensitivities

Gentofte Municipality, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 23947742 (View on PubMed)

Other Identifiers

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MCS-Re5

Identifier Type: -

Identifier Source: org_study_id

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