Abstract

BackgroundNoninvasive neurostimulation with transcranial Pulsed Electromagnetic Fields (tPEMF) may be a promising method for treatment resistant depression (TRD). Studies shown substantial improvement of depressive symptoms in patients with TRD, but there is no information on long-term antidepressant effects. The aim of this study was to investigate the short- and long-term efficacy of tPEMF in participants with TRD. MethodsEligible participants with TRD in this sham-controlled double-blind multicenter trial were randomly assigned to five weeks either daily active or sham tPEMF. Severity of depression and anxiety was assessed pre- and directly post-treatment and five and fifteen weeks post-treatment. Primary outcome was change on the 17-item Hamilton depression rating scale directly post-treatment. Secondary outcome was change on the Hamilton-17 during follow-up and change on the Inventory of Depressive Symptomatology Self-Report and the Beck Anxiety Index. ResultsOf the 55 included participants, 50 completed the treatment protocol. Depressive symptoms improved over time in both groups. The improvement continued until the last follow-up measure. There was no difference in outcome between the active and the sham group on change in depression post-treatment or on any secondary measure. ConclusionTreatment with this type of active tPEMF was not superior to sham in patients with TRD. This is in contrast to a previous study using a similar design and power calculation, but a higher magnetic field strength, that reported improvement of depression after treatment with tPEMF compared to sham. An important limitation of our study was the fact that no different dosing regimens were tried.

Highlights

  • Treatment of depression is often challenging; up to one third of pa­ tients suffering from a severe major depressive disorder (MDD) do not respond to four consecutively prescribed antidepressants (Rush et al, 2006) and are suffering from Treatment Resistant Depression (TRD)

  • We aimed to show the antidepressant effects of transcranial Pulsed Electromagnetic Fields (tPEMF) in treatment resistant depression (TRD) of a low intensity stimulation device

  • In this study we aimed to describe the direct and long-term antide­ pressant effects of tPEMF of a device utilizing a low intensity magnetic field in patients with treatment resistant depression

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Summary

Introduction

Treatment of depression is often challenging; up to one third of pa­ tients suffering from a severe major depressive disorder (MDD) do not respond to four consecutively prescribed antidepressants (Rush et al, 2006) and are suffering from Treatment Resistant Depression (TRD). The clinical antidepressant effect of rTMS relies on different dosing parameters, for example the stimulated brain region or the fre­ quency of the pulses, as well as the strength or intensity of the induced electromagnetic field (Milev et al, 2016). There was no difference in outcome between the active and the sham group on change in depression post-treatment or on any secondary measure. Conclusion: Treatment with this type of active tPEMF was not superior to sham in patients with TRD. This is in contrast to a previous study using a similar design and power calculation, but a higher magnetic field strength, that reported improvement of depression after treatment with tPEMF compared to sham. An important limitation of our study was the fact that no different dosing regimens were tried

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