The Flow brain stimulation headset for the treatment of depression: overview of its safety, efficacy and portable design

• Published in: Expert review of medical devices Vol. 17; no. 9; p. 867
• Main Authors: Borrione, Lucas, Suen, Paulo J C, Razza, Lais B, Santos, Leonardo Afonso Dos, Sudbrack-Oliveira, Pedro, Brunoni, André R
• Format: Journal Article
• Language: English
• Published: England 01-09-2020
• Subjects: Cognitive Behavioral Therapy; Depression - therapy; Equipment Design; Humans; Transcranial Direct Current Stimulation - adverse effects; Transcranial Direct Current Stimulation - instrumentation; Treatment Outcome; App; neuromodulation; psychotherapy; major depressive disorder; transcranial direct current stimulation
• ISSN: 1745-2422
• DOI: 10.1080/17434440.2020.1813565

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.
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.
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.