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Pulsed Electro Magnetic Fields (PEMF) in Depression (PEMF)

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ClinicalTrials.gov Identifier: NCT03556735
Recruitment Status : Completed
First Posted : June 14, 2018
Last Update Posted : April 19, 2019
Sponsor:
Collaborators:
Aarhus University Hospital
Rigshospitalet, Denmark
Aalborg University Hospital
Glostrup University Hospital, Copenhagen
Mental Health Centre Copenhagen
Odense University Hospital
Information provided by (Responsible Party):
Erik Roj Larsen, University of Southern Denmark

Brief Summary:
PEMF (Pulsed Electro Magnetic Fields) therapy has been used to stimulate bone repair in non-union since the 1970s. This is an accepted use, which has been approved by the Food and Drug Administration in the US. The mode of action of PEMF is based on creating small electrical fields in tissue and thereby promoting healing. Besides it has been shown that PEMF enhance regeneration of nerve fibers exposed to a lesion For treatment of depression the PEMF equipment, which are provided by the company Re5 A/S, consists of a 220 V impulse generator that creates electrical impulses and an applicator which consists of an electrical cable connected to a helmet on which there are 7 electrical coils on the inside. In comparison with the rTMS (Transcranial Magnetic Stimulation) equipment, which uses stimuli approaching neuronal firing level, the PEMF fields in human is very much lower.

Condition or disease Intervention/treatment Phase
Depression, Unipolar Device: Treatment with PEMF equipment Not Applicable

Detailed Description:

Applied to cells PEMF have a stimulatory effect on intracellular tyrosine kinase activity, especially the Src family. The Src family upregulate NMDAR (N-methyl-D-aspartate) subtype of glutamate receptor thereby gating the production of NMDAR-dependent synaptic potentiation that are vital for processes that underlie physiological and pathological plasticity in the brain. Dysregulation of fibroblast growth factor receptors in frontal cortical regions of the brain seem to be associated with depression. The fibroblast growth factors are highly dependent on the activity of the Src family.

For treatment of depression the PEMF equipment, which are provided by the company Re5 A/S, consists of a 220 V impulse generator that creates electrical impulses and an applicator which consists of an electrical cable connected to a helmet on which there are 7 electrical coils on the inside. In comparison with the rTMS equipment, which uses stimuli approaching neuronal firing level, the PEMF fields in human are very much lower.

PEMF treatment involves placing the treatment helmet on the head and connecting it to a power source (220 V), which leads to induction of a pulsating magnetic field. The treatment was given for 30 min once or twice daily for 8 weeks. Participants are awake during these treatments and sit in a chair where they can read or eat. Pilot data demonstrates that the treatment can give mild transient nausea. No other side effects have been observed.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation Plan for Pulsed Electro Magnetic Fields (PEMF) in a Cohort Study for Patients With Unipolar Depression, Refractory to Antidepressant Drugs. A DUAG (Danish University Antidepressant Group) Study Over 8 Weeks.
Actual Study Start Date : September 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
PEMF treatment
No sham group (placebo) was chosen. Treatment consisted of one active group in a multicenter study.
Device: Treatment with PEMF equipment
Treatment with PEMF in 8 weeks




Primary Outcome Measures :
  1. Change in the Hamilton Depression Scale (HAM-D17) [ Time Frame: 8 weeks ]
    HamD17 scale


Secondary Outcome Measures :
  1. Life Quality [ Time Frame: 8 weeks ]
    WHO-5 scale

  2. Side effects [ Time Frame: 8 weeks ]
    Prise scale

  3. Response and remission [ Time Frame: 8 weeks ]
    HamD17 scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treatment resistant depression is defined as treatment with at least two antidepressants from different classes in an optimal dose and with sufficient duration (at least 8 weeks).
  • A score on HamD17 above 17.
  • Antidepressant medication must not have been changed 4 weeks before inclusion.

Exclusion Criteria:

A Ham-D17 item 3 at 2 or more (suicidal risk increased) A moderate manic condition (MAS-M above 14) The participant must not be under some sort of restrictions Pregnancy Severe personality disorders Psychotic mental disorders Brain diseases


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556735


Locations
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Denmark
Department of Psychiatry, Psychiatry in the Region of Southern Denmark
Odense, Region Of Southern Denmark, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Aarhus University Hospital
Rigshospitalet, Denmark
Aalborg University Hospital
Glostrup University Hospital, Copenhagen
Mental Health Centre Copenhagen
Odense University Hospital
Investigators
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Principal Investigator: Erik R. Larsen, MD Institute of Clinical Research, Research Unit of Psychiatry, University of Southern Denmark

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Responsible Party: Erik Roj Larsen, Clinical associate professor, senior consultant, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03556735     History of Changes
Other Study ID Numbers: 1-10-72-125-16
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication in Peer-Reviewed Journals Participation in Congresses
Supporting Materials: Study Protocol
Time Frame: Planned to be published in 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Erik Roj Larsen, University of Southern Denmark:
Depression, unipolar
Treatment resistant
PEMF

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders