Flow launches a medication-free treatment for depression comprising a brain stimulation headset and therapy app. In Europe, Flow is classified as a Class IIa medical device intended for use as a treatment for depression and was certified by BSI’s Netherlands notified body. It is the first approved treatment of its kind in Europe available to buy and use at home. Randomised controlled trials published in the New England Journal of Medicine and the British Journal of Psychiatry showed that brain stimulation, of the type used in the Flow headset, had a similar impact to antidepressants but with fewer and less-severe side effects.
Flow is starting talks with the NHS to have its brain stimulation headset available on prescription. In 2019, Flow will also be working with the US Food and Drug Administration (FDA) to seek regulatory clearance in the USA.
People diagnosed with depression often have a lower neural activity in their left frontal lobe, the part of the brain controlling important cognitive skills, including emotional expression. The Flow headset uses transcranial direct current stimulation (tDCS), a form of neurostimulation that delivers constant, low direct current via electrodes on the head to stimulate neurons in this area and help rebalance activity. The brain stimulation delivered in the Flow headset is technically and clinically equivalent to devices used in these randomised controlled trials.
“By combining tDCS with behavioural therapy, the Flow team has created a powerful medical device treatment. I have seen first-hand the possibilities this technique has in providing a treatment for unipolar depression without the several adverse effects associated with pharmacological therapies,” said Andre Russowsky Brunoni, Psychiatrist, Associate Professor at the University of São Paulo Medical School and co-author of the study.
Treatment typically lasts for 30 minutes per session, with 18 sessions over six weeks. Continued treatment is then possible for one to two sessions per week.
During brain stimulation, users engage with a virtual therapist, via an app. This features videos and advice about depression, and how to reduce symptoms, using recent expert knowledge from the fields of sleep, nutrition, fitness and meditation.
“We want to support the improvement of the current standard of care for people living with depression by increasing treatment choice and empowering patients to self-manage their symptoms at home with effective, non-pharmacological, alternatives,” said Daniel Mansson, co-founder and CEO of Flow.