Headset advances depression treatment

Flow Neuroscience, makers of brain-stimulating headsets, released results from their recent clinical trial that point to a promising future for the treatment of depression. In the trial, their Flow tDCS headset proved to be twice as effective in treating depression as the current leading medication options.  

The Flow tDCS headset is under review for full FDA approval and if approved, it would be the first at-home treatment for depression. In July 2022, Flow obtained the FDA’s Breakthrough Device designation, which is reserved for medical devices that “offer significant advantages over existing approved alternatives.” The Sweden-based company already has regulatory approval in Europe.  

Flow works by delivering a low level electrical current to the brain. Particularly, the Dorsolateral Prefrontal Cortex, which is the area that regulates mood and focus. This technique is thought to modulate neuronal activity and neurotransmitter levels, potentially leading to improvements in mood and cognitive function. Flow Neuroscience’s innovative device combines tDCS with an app-based behavioral therapy program to create a comprehensive and personalized treatment approach. 

Depression symptom reduction 

The trial measured the progress of 173 patients who used the Flow headset at home. After the ten-week trial period, 56% of patients reported total alleviation of depression symptoms and 62% had a “clinical response,” meaning their symptoms improved by over 50%.   

The research revealed that individuals who received the active treatment had over threefold increased likelihood of experiencing significant improvement compared to those who underwent placebo/sham stimulation. This effect size was roughly twice as large as the average observed in trials for the FDA-reviewed top 21 antidepressants currently on the market. 

“These exciting and encouraging new data raise the prospect of a real advance in the treatment of depression. Major depression is undertreated throughout the world, and all of the currently widely used treatment modalities have significant limitations,” said Allan Young, Chair of Mood Disorders, Director of Centre for Affective Disorders in the Institute of Psychiatry, Psychology, and Neuroscience at King’s College London, in the release. 

“The nature of this treatment, being both effective and well tolerated, means that it is a treatment which may be widely adopted and should be a helpful intervention for many people suffering from major depression,” Young added.  

An alternative to drugs

The predominant treatment for depression is to medicate with selective serotonin reuptake inhibitors (SSRIs) like Prozac, Zoloft, and Lexapro. These  modify serotonin levels in the brain, which can come with a slew of side effects including weight gain and sexual problems. Medication management is complicated by the fact that our bodies can build tolerance to the drugs leading to a reduction in its effectiveness and a return of the original symptoms. 

A medical innovation like the Flow tDCS headset offers an alternative avenue for depression treatment that does not involve the chemical alteration of brain neurotransmitters. This has the potential to shield patients from the side effects and challenges associated with traditional medication approaches, providing a new and promising direction in the quest for effective and sustainable depression management. 

“Depression is one of the most common mood disorders, and unfortunately, it is also one of the hardest to treat,” said Flow Neuroscience Co-Founder Daniel Mansson. “Our core mission was to create a treatment that is effective and accessible to as many people as possible in their own homes, with little to no side effects. The results of this clinical trial show how effective this treatment has become and how breakthroughs are still possible in the treatment of depression.”