Curebase, Flow Neuroscience Announce Joint Clinical Trial for the use of an at-home tDCS device for treating depression
May 17, 2022
SAN FRANCISCO and MALMO, Sweden, May 17, 2022 /PRNewswire/ -- Curebase, a company committed to democratizing access to clinical studies, and Flow Neuroscience, creator of Europe's only medically approved transcranial direct current stimulation (tDCS) device and behavioral therapy app for depression, are launching a clinical trial in which participants will test the effectiveness of Flow's at-home headset in reducing depressive symptoms.
The Flow headset is the first portable tDCS device to be medically approved for home use in the U.K. and European Union. The brain stimulation technique used in the Flow headset, typically delivered only in-clinic, has been validated in longitudinal clinical trials, using double-blinded RCT studies, as an effective and safe treatment for depression. Providing a non-pharmaceutical alternative, the Flow headset works by delivering gentle electrical currents to an area called the dorsolateral prefrontal cortex to restore activity usually lowered in those with depression. The self-managed treatment's unique safety system and design allows for a remote solution that is immediately accessible to support patients in reducing their depression at home. Similarly, the remote capability of the Flow device enables reach, supporting decentralized clinical trials and further depression research at scale.
The trial will include 270 participants in London and Houston across two research centres, UTHealth and UEL. The University of Texas led by Dr. Sudhakar Selvaraj with co-researcher Professor Jair Soares and the University of East London led by Professor Cynthia Fu with co-researcher Professor Allan Young, King's College London. Testing the efficacy of using tDCS to treat depression through a portable device, the trial will see participants follow a treatment plan of ten weeks where they will have five stimulation sessions per week in the first three weeks and two stimulation sessions per week in the next seven weeks.
Powered by Curebase's decentralized clinical trial platform, initial data will be collected from participants at home securely as researchers can schedule virtual interviews as well as gather all electronic clinical outcome assessment (eCOA) data to select eligible participants. In addition, the company's patient management system will amplify efficiency as both researchers and participants can work effectively in the decentralized trial setup with scheduled virtual check-ins, collecting patient reported outcomes (ePROs) and sending reminders.
"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."
Major depressive disorders (MDD) affect 17.5 million adults in the U.S. and costs the economy $326 billion in 2018, up 38% from 2010, according to the latest research from Analysis Group. MDD can have a devastating impact on individuals, families and communities. Similarly, in the U.K. one in five adults reported having depressive symptoms in 2021. This is more than double from previous years, with younger populations and women amongst some of the most affected and mental health services are now reported to be at breaking point.
As this unmet need grows, so does the demand need for more treatment options. Decentralization allows for more large-scale trials to be executed faster so that researchers and companies can bring alternatives at a higher rate than ever before. Both the remote Flow technology and the Curebase platform in this trial have the unique capabilities to bring renewed hope to finding alternatives to treat depression.
The trial began in Mayis slated to begin in February, with data results expected in the fall. Flow is applying to the U.S. Food and Drug Administration (FDA) for approval of its at-home device and app as a treatment for depression.
"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." Flow co-founder and CTO, Erik Rehn comments. "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. 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."
Curebase's decentralized clinical trial model ensures more diverse studies through the inclusion of underrepresented populations. The company's virtual research sites also provide physicians with new and unique options to offer their patients, regardless of location. The Curebase platform empowers sponsors, CROs and physicians from practices of all sizes to conduct clinical research, including private practices, independent clinics, and large academic research sites.
About Flow Neuroscience
Flow Neuroscience is the creator of Flow, a physical and behavioural at-home treatment for depression that comprises a brain stimulation headset and therapy app. It is the first and only medically approved treatment for depression of its kind in Europe. Classified as a Class IIa medical device, Flow was developed from the fields of clinical psychology, neuroscience and innovative technology. Flow empowers and motivates individuals to take control and self-manage their depression with effective, non-pharmacological, digital alternatives. Based in Malmö, Sweden, Flow was founded in 2016 by clinical psychologist Daniel Mansson and neuroscientist Erik Rehn. Their team consists of prominent researchers in the field of psychiatry and brain stimulation.
At Curebase, our mission is to bring quality medical innovations to patients faster and improve human wellbeing through more efficient clinical studies. We are proving that clinical research can be radically accelerated if we empower physicians everywhere to enroll patients in the communities where they live. By applying cutting edge clinical software and remote study management techniques to the problem, we are reinventing clinical trials and research from the ground up.