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Pulsed Electro Magnetic Fields (PEMF) in Depression

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03556735
Acronym
PEMF
Enrollment
59
Registered
2018-06-14
Start date
2016-09-30
Completion date
2017-12-31
Last updated
2019-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Unipolar

Keywords

Depression, unipolar, Treatment resistant, PEMF

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.

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.

Interventions

DEVICETreatment with PEMF equipment

Treatment with PEMF in 8 weeks

Sponsors

Aarhus University Hospital
CollaboratorOTHER
Rigshospitalet, Denmark
CollaboratorOTHER
Aalborg University Hospital
CollaboratorOTHER
Glostrup University Hospital, Copenhagen
CollaboratorOTHER
Mental Health Services in the Capital Region, Denmark
CollaboratorOTHER
Odense University Hospital
CollaboratorOTHER
University of Southern Denmark
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the Hamilton Depression Scale (HAM-D17)8 weeksHamD17 scale

Secondary

MeasureTime frameDescription
Life Quality8 weeksWHO-5 scale
Side effects8 weeksPrise scale
Response and remission8 weeksHamD17 scale

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026