Pulsed Electro Magnetic Fields (PEMF) in Depression

NCT03556735 | Completed DMC

• 1 other identifier: 1-10-72-125-16
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Unipolar

Keywords

Depression, unipolar; Treatment resistant; PEMF

Outcome Measures

Primary Outcomes (1)

• Change in the Hamilton Depression Scale (HAM-D17)

  HamD17 scale

  8 weeks

Secondary Outcomes (3)

• Life Quality

  8 weeks

• Side effects

  8 weeks

• Response and remission

  8 weeks

Study Arms (1)

PEMF treatment

OTHER

No sham group (placebo) was chosen. Treatment consisted of one active group in a multicenter study.

Device: Treatment with PEMF equipment

Interventions

Treatment with PEMF equipment DEVICE

Treatment with PEMF in 8 weeks

PEMF treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Aarhus University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• Aalborg University Hospital: collaborator
• Glostrup University Hospital, Copenhagen: collaborator
• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: collaborator
• Odense University Hospital: collaborator

Study Sites (1)

Department of Psychiatry, Psychiatry in the Region of Southern Denmark

Odense, Region Syddanmark, 5000, Denmark

Location

MeSH Terms

Conditions

Depressive Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Erik R. Larsen, MD

  Institute of Clinical Research, Research Unit of Psychiatry, University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor, senior consultant

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 14, 2018
• Study Start: September 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 19, 2019

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Planned to be published in 2018

Locations

DK (1)