Expert review of medical devices · 2020
The Flow brain stimulation headset for the treatment of depression: overview of its safety, efficacy and portable design.
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Borrione Lucas, Suen Paulo J C, Razza Lais B, Santos Leonardo Afonso Dos, Sudbrack-Oliveira Pedro, Brunoni André R
Аннотация
INTRODUCTION: Major depressive disorder (MDD) is a prevalent and debilitating condition. First-line treatments include antidepressants and cognitive-behavioral psychotherapy (CBT). However, several patients present treatment-resistance and/or adverse effects. Transcranial direct current stimulation (tDCS), a noninvasive neuromodulation technique, is an effective alternative for MDD.
AREAS COVERED: We hereby review a portable tDCS device designed to be combined with a cognitive-behavioral intervention. This home-use device was developed by Flow Neuroscience™ and was recently approved in the UK and European Union. We discuss present evidence on tDCS efficacy and safety, both as a monotherapy and as a combined treatment. Moreover, we show a computer modeling tDCS procedure based on Flow parameters and montage.
EXPERT OPINION: Electric field simulations revealed that Flow's tDCS device targets prefrontal cortical areas involved in MDD pathophysiology. In addition, the safety and efficacy profile revealed from prior tDCS studies support its use in depression. Finally, combining tDCS with cognitive-behavioral interventions might further enhance overall efficacy, although this aspect should be investigated in upcoming randomized, placebo-controlled trials.
AREAS COVERED: We hereby review a portable tDCS device designed to be combined with a cognitive-behavioral intervention. This home-use device was developed by Flow Neuroscience™ and was recently approved in the UK and European Union. We discuss present evidence on tDCS efficacy and safety, both as a monotherapy and as a combined treatment. Moreover, we show a computer modeling tDCS procedure based on Flow parameters and montage.
EXPERT OPINION: Electric field simulations revealed that Flow's tDCS device targets prefrontal cortical areas involved in MDD pathophysiology. In addition, the safety and efficacy profile revealed from prior tDCS studies support its use in depression. Finally, combining tDCS with cognitive-behavioral interventions might further enhance overall efficacy, although this aspect should be investigated in upcoming randomized, placebo-controlled trials.