Device delivers currents to the brain to restore activity usually lowered in depression patients
Curebase and Flow Neuroscience are launching a clinical trial testing the effectiveness of Flow’s at-home headset in reducing depressive symptoms. The Flow headset is the first transcranial direct current stimulation (tDCS) device to be medically approved for home-use in the UK and EU.
The Flow headset uses a brain stimulation technique typically only delivered in-clinic. The technique has been validated in longitudinal clinical trials, using double-blinded, randomised control studies, as an effective and safe treatment for depression, and provides a non-pharmaceutical alternative for its management.
Flow co-founder and chief technology officer, Erik Rehn said: “This is a pinnacle moment as we embark on collecting large-scale data for the use of brain stimulation delivered via a portable device to treat depression.
“As we have the ability to carry out this clinical trial remotely, powered by Curebase’s platform and the Flow device, we will be able to reach more participants efficiently and bring results for new treatment options faster than would be possible with in-clinic trials using in-clinic devices.”
He added: “These results will pave the way for FDA approval of the Flow at-home brain stimulation treatment for major depressive disorder, enabling access to a non-pharmaceutical option for this debilitating condition.”
The headset delivers gentle electrical currents to an area of the brain called the dorsolateral prefrontal cortex to restore activity which is usually lowered in those suffering from depression.
“Flow’s brain stimulation treatment has been shown in Europe to be an effective and safe alternative to medication for people battling depression,” said Tom Lemberg, founder and CEO of Curebase. “We are excited to be partnering with Flow Neuroscience on this important clinical trial.”
The trial will include 270 participants in London and Houston across two research centres – UTHealth and UEL – and will test the efficacy of tDCS in the treatment of depression through a portable device.