Malmö, Sweden-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, promising similar outcomes as antidepressants, but with fewer side effects.
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 also the first approved treatment of its kind in Europe available to buy and use at home.
Flow is starting talks with the NHS to have its brain stimulation headset available by prescription. Later this year, the company aims to work with the 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, which includes videos and advice about depression and how to reduce symptoms, using 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, which is used for 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.
“We want to support the improvement of the current standard of care for people living with depression by increasing treatment choice and empower patients to self-manage their symptoms at home with effective, non-pharmacological, alternatives,” Daniel Mansson, Flow co-founder and CEO, said in a statement.
In the UK, the Flow headset sells for £399 and can be purchased online. The Flow virtual therapy app, available on iOS, is free to download.