FDA Approves Launch for Largest Clinical Trial for tDCS Device to Treat Depression

Flow Neuroscience has received the full FDA Investigational Device Exemption to launch its largest trial using the transcranial direct current stimulation (tDCS) headset for the treatment of major depressive disorder. Flow combines tDCS and behaviour therapy in a headset and app treatment programme designed for use at home. The results from the previous trial using tDCS for depression showed that this treatment could be readily accessible for US populations and possibly the UK in the future as an alternative to medications. With the prevalence of depression been increasing in the UK, tDCS has been seen as an effective treatment for people’s depression symptoms. A pivotal trial will commence to gather more clinical evidence for tDCS to work towards offering an alternative for patients and reach adult populations who remain untreated in the US. The data produced from the clinical trial will allow clinicians, researchers, and those suffering from depression to access a validated technique.

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