Nearly one in four adults in the UK are affected by a mental illness, and suicide is the most common cause of death for men aged 20-49 years in England and Wales. Malmö-based Flow Neuroscience has invented a new, medication-free treatment for depression, comprised of a brain stimulation headset and therapy app, and has now launched in the UK.
The technology has similar outcomes as antidepressants, but with fewer side effects. We just featured Flow as one of our 10 European startups revolutionizing mental health.
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 by prescription. This year, Flow will also be working with the Food and Drug Administration (FDA) to seek regulatory clearance in the US.
Treatment typically lasts for 30 minutes per session, with 18 sessions over 6 weeks. Continued treatment is then possible for 1-2 sessions per week. During the brain stimulation, users engage with a virtual therapist through an app. This includes videos and advice about depression and how to reduce symptoms, using recent expert knowledge from the fields of sleep, nutrition, fitness and meditation.
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,” said Andre Russowsky Brunoni, Psychiatrist and Associate Professor at the University of São Paulo Medical School. “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.”
“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, Flow co-founder and CEO.