A new brain stimulation headset has received approval from the Therapeutic Goods Administration (TGA) for at-home treatment of major depressive disorder (MDD). This advancement, confirmed on September 22, 2023, aims to address the lengthy waitlists faced by individuals seeking depression treatment in Australia.
The device, developed by Flow Neuroscience, enables patients to engage in treatment independently. After receiving a prescription from a clinician, users can utilize the headset at home and monitor their progress through a mobile app, which tracks key indicators like mood, sleep quality, and concentration levels. The technology specifically targets the prefrontal cortex, a brain region crucial for mood regulation and stress response, using low electrical currents to stimulate neuronal activity.
According to Dr Kultar Singh Garcha, global medical director at Flow Neuroscience, these electrical currents enhance the connectivity of neurons, helping to restore the brain to a healthier state. “This strengthens their connectivity, rebalancing the brain to a healthy state,” Dr Garcha stated.
Patients typically observe symptom improvement within approximately ten weeks of use. However, Flow Neuroscience recommends that treatment continue for a period of 6 to 12 months to mitigate the risk of relapse in individuals who respond positively to the therapy. This approach offers a significant advantage over traditional antidepressants, which often require months to show results and can entail extensive trial and error. Furthermore, the side effects associated with these medications—such as sleep disturbances, weight gain, and sexual dysfunction—can hinder recovery.
Protocol and Accessibility
The recommended usage protocol for the Flow headset consists of five or fewer 30-minute sessions per week, determined by the prescribing clinician. During each session, the device is placed on the user’s head and activated to initiate brain stimulation. Following the ten-week period, patients have the option to adjust the frequency of their sessions if a stronger effect is needed.
Prior to its approval in Australia, the Flow headset had received endorsements in several countries, including Switzerland and the United Kingdom. Flow Neuroscience reports that over 50,000 individuals worldwide have utilized the device, highlighting its growing acceptance and potential impact.
Potential Impact on Mental Health Services
The introduction of this headset could significantly alleviate the pressure on mental health services, which currently face long waitlists for treatment. Steve Mathews, a representative from Riverina Bluebell, a not-for-profit organization dedicated to raising awareness about mental health in New South Wales, emphasized the potential of this device to serve as a “silver bullet” during times of increased demand for mental health support.
“The long waiting lists and the shortage of professionals make it really difficult,” Mathews noted. “So this could be a silver bullet, and anything that can help in the meantime to get people through has to be a good thing.”
While the headset shows promise, Mathews also cautioned that individual experiences with depression vary greatly. “Everybody is different; while the diagnosis might be the same, they’ve all got different trigger points, and they are at different stages and different levels.”
The device is approved for use by individuals aged 18 years and older. As the mental health landscape continues to evolve, innovative solutions like the Flow headset may play a crucial role in enhancing access to effective treatment options.
