This morning, Malmö-based medical device company Flow has announced that it is launching its brain stimulation headset and therapy app to treat depression in the UK.
HOW IT WORKS
Priced at £399, the headset uses transcranial direct current stimulation (tDCS) - a non-invasive treatment using direct electronic currents to stimulate specific parts of the brain in order to help rebalance activity, according to Johns Hopkins Medicine.
“It works by sending a weak electric current, the equivalent of a 9 volt battery, into the frontal parts of the brain. The result is increased activity in the left part of the frontal lobe and decreased activity in the right part of the brain,” Flow details on its website.
The headset is marked as a Class IIa medical device intended for use as a treatment for depression in Europe, certified by the British Standards Institute.
It comes with an app that provides video content, information and advice designed to help patients make behavioural changes known to reduce symptoms of depression, and the treatment lasts for half an hour per session, with 18 carried out over a six-week period, and continued treatment possible afterwards for up to two sessions a week.
Although individuals do not need to have a prescription to use Flow, the company advises them to see a healthcare professional before purchasing the headset.
WHY IT MATTERS
According to the World Health Organisation, over 300 million people around the world suffer from depression, which is the leading cause of disability globally, and less than half receive effective treatments.
A systematic review and network meta-analysis published in the BMJ towards the end of March, which examined brain stimulation for acute treatment of major depressive episodes, concluded that “there is evidence for the consideration of non-surgical brain stimulation techniques as alternative or add-on treatments”.
The experts noted: “Our findings also highlight important research priorities in the specialty of brain stimulation, such as the need to conduct further randomised controlled trials for novel treatment protocols.”
ON THE RECORD
Andre Russowsky Brunoni, associate professor at the University of São Paulo Medical School and co-author of a study that looked to compare tDCS with a type of antidepressant commonly prescribed, said: "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."
Flow said that it was “starting talks” with the NHS to have its headset available on prescription, and that it would also look to obtain regulatory clearance from the FDA in the US.
“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,” cofounder and chief executive of the company Daniel Mansson added in a statement.