The Flow Neuroscience brain stimulator is now TGA-approved for at-home treatment of depression. Photo: Flow Neuroscience.
Brain stimulation for depression, at home and without taking pills, is now available after Therapeutic Goods Administration (TGA) approval.
Aurora BioScience Pty Ltd sponsored the ‘Transcranial electrical stimulation system, continuous-current, home-use’ device for the Australian Register of Therapeutic Goods.
A brain stimulation device product called the Transcranial Direct Current stimulator (tDCS) and associated software applications for treatment of mental and neurological disorders (Depression) is a class IIa Medical Device intended for adults (18+) diagnosed with Major Depressive Disorder (MDD).
Flow Neuroscience markets the device for at-home treatment of depression, saying that with rising waiting times in the Australian mental healthcare system, the approval of the stimulator expands timely access to depression treatment.
Waiting times for mental health services have risen more than threefold over the past decade, while almost one in five Australians experience depressive episodes, according to the latest data.
The Productivity Commission’s review this year of service delays suggests they are among the major barriers, along with staff shortages, to accessing mental health and suicide prevention services in this country.
The tDCS-based brain stimulation headset is for the treatment of major depressive disorder. It must be prescribed and set up by a medical clinician for patients to use independently at home, with scheduled check-ins.
Flow Neuroscience’s global medical director, Kultar Singh Garcha, said the TGA’s approval of the device offers a new dimension to the treatment of depression.
“With Australian doctors now able to prescribe Flow for at-home use, patients can begin treatment immediately and see the effect within weeks,” Dr Garcha said
“In comparison, antidepressants can take months to show results and may require years of trial and error, and side effects like sleep problems, weight gain or sexual dysfunction can further slow recovery.”
Flow has previously conducted a landmark study, published in Nature Medicine, on the effectiveness of its device.
Latest data confirms that more than 70 per cent of patients report a reduction in their depressive symptoms within three to six weeks of use, a much better response to treatment than antidepressants.
The study also found side effects were limited to mild tingling or itching at the electrode site.
Over 10 weeks in randomised controlled trials, active tDCS achieved two to three times higher response and remission rates, even among patients already on medication or psychotherapy, making it far closer to real-world conditions than most previous trials.
Dr Garcha said the non-invasive brain stimulation technology behind the device specifically regulates activity in the prefrontal cortex, the part of the brain involved in mood regulation and stress response, which is often underactive in people with depression.
“tDCS stimulates the prefrontal cortex with low electrical currents, which activate neurons’ ability to respond to signals from other neurons,” he said.
“This strengthens their connectivity, rebalancing the brain to a healthy state.”
The usage protocol involves five or fewer 30-minute sessions per week, or as recommended by a clinician.
During the sessions, the device is placed on the head and turned on, initiating the process of brain stimulation.
Sessions can be conducted while sitting, reading, or engaging in other routine activities.
Flow Neuroscience chief executive officer Erin Lee praised the Federal Government authority for recognising the value and safety of the device for patients. Before its approval by the TGA, the Flow headset has been used by more than 50,000 users in the EU, UK, Switzerland, and Hong Kong.
In the UK, it is also NHS-approved and has been prescribed by doctors within the public health system.
“Governmental health systems all over the world find it challenging to adapt the clinical practice to rapidly rising mental health demands, but we are glad Australia is moving forward,” Ms Lee said.
“Now TGA-approved, Flow can help clinicians extend depression care into the home, easing pressure on services without compromising the oversight.”
Flow Neuroscience is a healthcare company focused on non-drug therapies for depression.
Founded in Sweden in 2016 by clinical psychologist Daniel Mansson and engineer Erik Rehn, the company launched its medical tDCS headset in Europe in 2019.
