NCT01834781

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 16, 2014

Status Verified

April 1, 2014

Enrollment Period

11 months

First QC Date

April 12, 2013

Last Update Submit

April 15, 2014

Conditions

Multiple Chemical Sensitivity

Keywords

multiple chemical sensitivity, re5 therapy, pulsed electromagnetic fields

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (13)

  • Change from baseline in Symptom Severity Scale (Quick Environmental Exposure and Sensitivity Inventory)

    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)

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

  • Change from baseline in Sheehan Disability Scale

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

  • Change from baseline in individual self-selected tasks

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

  • Change from baseline in noise sensitivity

    Week 6, and 2½ and 4½ month follow-ups

  • +8 more secondary outcomes

Study Arms (2)

Pulsed electromagnetic fields

ACTIVE COMPARATOR

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

Device: Pulsed electromagnetic fields

Wearing the inactive device

PLACEBO COMPARATOR

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

Interventions

Pulsed electromagnetic fieldsDEVICE
Also known as: Re5 Independent System, Re5 therapy
Pulsed electromagnetic fields
w/o pulsed electromagnetic fieldsDEVICE
Wearing the inactive device

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Danish Research Centre for Chemical Sensitivities

Gentofte Municipality, DK-2820, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 23947742DERIVED

MeSH Terms

Conditions

Multiple Chemical Sensitivity

Condition Hierarchy (Ancestors)

Environmental IllnessHypersensitivityImmune System DiseasesDisorders of Environmental Origin

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2013

First Posted

April 18, 2013

Study Start

April 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 16, 2014

Record last verified: 2014-04

Locations

DK(1)