The Therapeutic Goods Administration (TGA) in Australia has approved a new brain stimulation device developed by Flow Neuroscience for treating major depressive disorder. This intuitive wearable is the first with advanced transcranial Direct Current Stimulation (tDCS) technology. This provides an additional treatment alternative for Americans who continue to fight depression.
Flow Neuroscience’s device comprises a modified version of that same headset with dual pads that sit on the forehead. These small pads deliver a low-intensity electrical current to the dorsolateral prefrontal cortex. This area of the brain is typically less active in individuals suffering from major depression. The device has already created quite a splash in Europe and the United Kingdom, quickly attracting around 50,000 users in its four-year existence. PMP is becoming more popular in the U.S.
In Australia, it is limited to just people 18 and older. They need to have a formal diagnosis of major depressive disorder. Clinical oversight is absolutely necessary for its use. This helps provide a user with continuous monitoring no matter where they are in their treatment path.
Background of the Technology
Flow Neuroscience’s device is based on pioneering research by Professor Colleen Loo at the University of New South Wales. With the Black Dog Institute, her research tested the feasibility and acceptability of text-message based interventions. At the Black Dog Institute, Professor Loo has been operating a Clinic for about 10 years. In his practice, he provides treatment alternatives that emphasize these same techniques.
“We’ve been running a clinic at the Black Dog Institute for probably almost 10 years now, offering this,” – Professor Colleen Loo
CEO of Flow Neuroscience, Erin Lee, stressed the importance of this technology in delivering new treatment options to patients. Her deeper goal was to use the device to activate a key brain region known to play an important role in depression.
“When we look at pictures of depressed brains, what we’ll often see is lower activity in that particular region, and so what we’re doing is using that mild electricity to re-stimulate activity and reduce symptoms,” – Erin Lee
For the millions of people over the world who need this device, it is bringing hope. It equally needs to be acknowledged that it’s probably the least effective of the treatments, I mean electroconvulsive therapy, ketamine.
Expert Opinions and Concerns
Since the announcement, experts have had a cautiously optimistic take on its potential. Professor Ian Hickie said that the device provides a significantly improved treatment alternative. He noted that the evidence for its effectiveness, particularly for severe cases of depression, is still inconclusive.
“The evidence is much more mixed as to whether it’s a really useful treatment, particularly in more severe forms of depression,” – Professor Ian Hickie
Moreover, there is a moral panic around patients self-medicating outside the oversight of a licensed medical professional.
“There is a danger, with the DIY approach, that people who really require more significant treatments don’t get them, and they’re further delayed in receiving effective treatment,” – Professor Ian Hickie
Professor Loo expressed these concerns. He cautioned that some people might treat the device as a panacea for their disease, causing a deterioration in their state without the proper guidance from a trained professional.
“I do have concerns about people who are seeing this as a self-treatment option and who may be either doing themselves harm or coming to grief because they’re treating themselves, they’re getting worse, they’re feeling suicidal, and then not having proper treatment,” – Professor Colleen Loo
The Role of Flow Neuroscience’s Device
“Professor Loo was impressed that Flow Neuroscience’s device fills a major treatment gap. It gives hope to anyone who has had a hard time with taking medications or has not been helped by the usual route of treatment.
“But it fills a nice gap in the middle ground for people who haven’t got well with medications or can’t tolerate medications, but who need some kind of biological treatment,” – Professor Colleen Loo
Erin Lee pictured, right explaining how the device works. In addition, she mentioned that consumers would be provided with specific instructions on how to place the headset so that they get the best results. The device interacts with a user-facing mobile app that tracks all the parameters to maintain safety and efficacy.
“Because the device speaks with our user-facing app, we’re monitoring current, we are monitoring connectivity, and so we make sure that it’s in the right place [on your head] and that it is delivering the right type of current,” – Erin Lee
