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
|Condition or disease||Intervention/treatment||Phase|
|Depression, Unipolar||Device: Treatment with PEMF equipment||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Change in the Hamilton Depression Scale (HAM-D17) [ Time Frame: 8 weeks ]HamD17 scale
- Life Quality [ Time Frame: 8 weeks ]WHO-5 scale
- Side effects [ Time Frame: 8 weeks ]Prise scale
- Response and remission [ Time Frame: 8 weeks ]HamD17 scale
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
|Department of Psychiatry, Psychiatry in the Region of Southern Denmark|
|Odense, Region Of Southern Denmark, Denmark, 5000|
|Principal Investigator:||Erik R. Larsen, MD||Institute of Clinical Research, Research Unit of Psychiatry, University of Southern Denmark|