Pulsed Electro Magnetic Fields (PEMF) in Depression

Sponsor

University of Southern Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT03556735

Collaborator

Aarhus University Hospital (Other), Rigshospitalet, Denmark (Other), Aalborg University Hospital (Other), Glostrup University Hospital, Copenhagen (Other), Mental Health Centre Copenhagen (Other), Odense University Hospital (Other)

Enrollment

Location

Arm

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

N/A

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 :

Sep 1, 2016

Actual Primary Completion Date :

Nov 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Arm

Intervention/Treatment

Other: 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

Outcome Measures

Primary Outcome Measures

Change in the Hamilton Depression Scale (HAM-D17) [8 weeks]
HamD17 scale

Secondary Outcome Measures

Life Quality [8 weeks]
WHO-5 scale
Side effects [8 weeks]
Prise scale
Response and remission [8 weeks]
HamD17 scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Principal Investigator: Erik R. Larsen, MD, Institute of Clinical Research, Research Unit of Psychiatry, University of Southern Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Erik Roj Larsen, Clinical associate professor, senior consultant, University of Southern Denmark

ClinicalTrials.gov Identifier:

NCT03556735

Other Study ID Numbers:

1-10-72-125-16

First Posted:

Jun 14, 2018

Last Update Posted:

Apr 19, 2019

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Erik Roj Larsen, Clinical associate professor, senior consultant, University of Southern Denmark

Depression, unipolar

Treatment resistant

PEMF

Additional relevant MeSH terms:

Depression

Depressive Disorder

Study Results

No Results Posted as of Apr 19, 2019