Clinical trial NCT03556735: Pulsed Electro Magnetic Fields (PEMF) in Depression
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Unipolar
Keywords: Depression, unipolar
Treatment resistant
PEMF
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Rigshospitalet, Denmark
name: Aalborg University Hospital
name: Glostrup University Hospital, Copenhagen
name: Mental Health Services in the Capital Region, Denmark
name: Odense University Hospital
First posted: 2018-06-14
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in the Hamilton Depression Scale (HAM-D17)
timeFrame: 8 weeks
Secondary outcomes:
measure: Life Quality
timeFrame: 8 weeks
measure: Side effects
timeFrame: 8 weeks
measure: Response and remission
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Psychiatry, Psychiatry in the Region of Southern Denmark
state: Region Of Southern Denmark
Study officials:
affiliation: Institute of Clinical Research, Research Unit of Psychiatry, University of Southern Denmark
name: Erik R. Larsen, MD
role: PRINCIPAL_INVESTIGATOR
References: