Could a headset and a smartphone app really treat depression? That's Flow's claim for the medically approved brain stimulation headset, a device that pushes your neurons with a gentle electrical current, and one you can buy and use in your own home.
For more information on severe depressive disorder, you can also read more on the mental health organization Mind, the NHS website or WebMD.
Flow is a medical technology company that was founded in 2016 and is currently based in Sweden. Its chief executive, clinical psychologist Daniel Mansson, founded the company after writing his thesis on brain stimulation and has years of experience working at the intersection of psychology and software.
We've heard about electric shocks from headphones that help you juggle, but can a hardware product really succeed instead of or even start helping existing medical treatments with depression?
To get a head start on the potential health benefits of a product like this, I spoke with Flow CEO Daniel Mansson while handling a Flow headset to get a feel for the hardware offered.
What is the Flow Headset?
The flow headset is a bit like a VR headset, except that the curved white visor sits solely on your forehead, with a strap that hooks over the top of your head to hold it in place.
The box also comes with a disposable cloth box to place between your skin and the suction pads on the headset, as your skin probably doesn't respond well to direct electric currents.
The treatments last about 30 minutes, "with 18 sessions over a 6-week period" (three times a week) or "as long as needed". The headset is designed to be used in tandem with a virtual therapy app that helps inform users about depression and the kind of "lifestyle changes" the patient can make with their diet, exercise regimen, sleep hygiene and meditation (the app is only on iOS).
There is something a little nervous about the idea of self-administering a mild form of shock therapy, but there are existing therapies that use the same underlying technology: transcranial DC (or TDCS).
This treatment is a non-invasive way to stimulate the brain with mild electrical currents using battery-powered electrodes.
Flow's website states that “People who are diagnosed with depression often have lower activity in the left frontal cortex of their brain. The headset delivers a gentle electrical signal that activates neurons and frontal leg rebalancing activity.
"The headset is based on a well-researched brain stimulation technology called Transcranial Direct Current Stimulation, which has been shown to improve reliable symptoms of depression in clinical trials."
Wait, is this a real thing?
It claims that the claims sound somewhat sci-fi, the technology has undergone numerous medical trials, with the evidence enough to get Flow headsets approved for medical use in England and Europe.
Mansson tells me that Flow is seeking a similar medical approval in the US and is in talks with the UK & # 39; s National Health Service to offer the headset through prescription.
The treatment is listed on the NHS website as a method of treatment, and the National Institute for Health and Care Excellence (NICE) claims there are "no major safety concerns", although patients need to be taken through the risks and side effects associated with it.
You are strongly advised does not to use the headset without the approval of a physician and an official diagnosis of Major Depressive Disorder. Anyone with an "already existing neurological condition" or with broken skin at the point of contact with the headset should pay special attention.
I made a mistake next to caution here – like someone more familiar with anxiety treatments than those used for depression – so I can't speak about the effectiveness myself.
However, both British Journal of Psychiatry and New England Journal of Medicine has published the results of randomized controlled trials using the kind of brain stimulation used in the Flow headset.
Both trials mentioned above worked with several hundred patients (289 in the former, 245 in the latter), with the British Journal of Psychiatry calling the treatment "comparable" to "antidepressant medical treatment in primary care."
However, the New England Journal of Medicine was more hesitant and reported "more side effects" effects – such as "skin redness, tinnitus and nervousness" […] and mania with beginner ”- with no obvious improvement over other forms of therapy. Another study published by the online journal Brain Stimulation discouraged its use in patients prone to seizures or epilepsy.
Flow CEO Daniel Mansson says the company worked for over two years to "ensure that all safety standards and good manufacturing practices were met and documented" before being granted the stamp of approval in June 2019.
But some skepticism is appropriate given the inconsistent results of the mental health treatments previously available to patients in the UK and Europe.
Depression, for all its widespread use in our community (World Heath Organization estimates 300 million people living with the condition worldwide), are really not well understood – and there are a number of different strategies to tackle the problems.
An in-depth psychoanalysis may be recommended to understand the underlying psychological causes, given cognitive behavioral therapy to tackle behavioral symptoms, or given medication as a chemical solution – if not a combination of the three with varying degrees of success.
Also, you can't recommend these things when you need them, given how severe mental illness can be to diagnose. So offering a DIY solution you can buy yourself – bypassing long and potentially triggering consultations, even if you're not meant to do it without medical approval – offers a convenience in itself.
"The combination of the brain stimulation headphone and therapy app," says Mansson, "creates a new, very powerful, but also very safe, home care solution."
There has been tremendous growth in the form of self-care and meditation apps like HeadSpace – often actively recommended by GPs in the UK – offering ways to deal with stress, pain or anxiety.
Of course, costs become a problem when patients are expected to find healthcare outside of national healthcare. Flow headsets cost £ 399 (about $ 480 / AU $ 710) at no additional cost – while the HeadSpace app, in comparison, sets you back $ 95 / £ 72 / AU $ 149 for a one-year subscription.
Mansson makes sure that Flow is just a tool "in the toolbox for treatments", but as a commercially available hardware product, it has the potential to change the way patients commonly receive treatment, especially if costs are scaled down.
“Right now, we are seeing a shift from pharmacological treatments to more digital therapy-based alternatives,” says Mansson, “which empowers patients and motivates them to treat their own condition based on their home comforts.
"Given that brain-stimulating devices (if medically approved) offer few side effects and are affordable and accessible, it makes perfect sense that devices like Flow will become more and more popular."
So … should I get one?
Well, not from your own bat. The jury is out on the effectiveness of tDCS, though it is slowly gaining more traction as a potential aid to severe depressive disorder.
Given the growing push toward more digitally-based therapies and nursing treatments, the signs suggest that there will be more treatments like these proposed by doctors in the future.
But neither Flow nor I would recommend picking this up on a whim, and you really have to wait until your doctor recommends it to help with your specific needs.
For more information, go to Flow-site.