A recent study has indicated that a novel headwear device, which delivers a mild electrical impulse equivalent to that of a 9-volt battery to the brain, may offer significant relief for individuals suffering from depression.

The research, published in the prestigious journal Nature Medicine, involved 87 adults diagnosed with at least moderate levels of depression who utilized the headwear for a period of 10 weeks. The results were compared to a control group of 87 individuals who used a similar-looking, but inactive, headwear over the same duration. The findings revealed that those who used the active device experienced a more substantial improvement in their depressive symptoms. Moreover, the remission rate of depressive symptoms was nearly double in the treatment group compared to the placebo group, with 45% reporting remission versus 22% in the control group.

Dr. Rodrigo Machado-Vieira, a psychiatrist and director of the Experimental Therapeutics and Molecular Pathophysiology Program at UTHealth Houston, one of the institutions involved in patient recruitment for the study, clarified that remission implies the absence of an active mood episode. Patients in remission might still report minor issues such as sleep disturbances or anxiety, but their symptoms would not be severe enough to be classified as clinically depressed.

Dr. Machado-Vieira disclosed that while the company manufacturing the headwear funded the study, the financial support was directed towards a general research fund at his university, and he had no personal financial interest in the product. The device is currently available in the UK, Norway, Hong Kong, and several European Union countries, and is manufactured by a Swedish firm named Flow Neuroscience. The company is reportedly in the final stages of seeking approval from the US Food and Drug Administration to market the device for treating depression in the United States. While similar devices are available in the US market, they typically do not claim to treat any specific symptoms or conditions, instead promising to enhance alertness and concentration without targeting specific brain regions. In contrast, the Flow Neuroscience headwear is designed to stimulate two particular brain areas through the use of an app with a video tutorial and a telemedicine consultation to ensure proper electrode placement.

The first area targeted is the dorsolateral prefrontal cortex, which plays a role in executive functions and cognition. The second is the ventromedial prefrontal cortex, involved in emotional regulation. Research suggests that individuals with depression often exhibit reduced activity in the dorsolateral prefrontal cortex and increased activity in the ventromedial prefrontal cortex compared to the general population. The device aims to normalize brain activity by accelerating it in the underactive region and decelerating it in the overactive region, as explained by Daniel Mansson, a clinical psychologist and co-founder of Flow Neuroscience. The technology employed by the device is known as transcranial direct current stimulation, which uses a low-level electrical current to modulate the action potential of neurons, facilitating their proper functioning. Dr. Cynthia Fu, a professor at the Centre for Affective Disorders at King’s College London and the lead researcher of the study, confirmed that she also has no financial ties to the device.

Leana De Hoyos, a 34-year-old mother of two from Houston, participated in the study. Having struggled with mental health issues since her teenage years, De Hoyos was eager to test the Flow headwear when invited by her psychiatry clinic. She described one of her most challenging symptoms as executive dysfunction, where she mentally desires to perform tasks but is physically unable to do so, often feeling overwhelmed. For the study, De Hoyos would don the headwear and join a computer meeting where a study observer would monitor her for 30 minutes during the treatment session. She described the brain stimulation as starting with a slight buzzing sensation, followed by a tingling and burning feeling, akin to the experience of hair bleaching, which she described as a "spicy sensation." Over several weeks, De Hoyos noticed a change in her motivation to carry out tasks. One of her significant struggles was maintaining a clean home, often resulting in piles of miscellaneous items that needed to be organized. However, after using the headwear, these "doom piles" began to vanish. She expressed amazement at her newfound ability to manage household tasks without much external assistance.

Upon the study's conclusion, De Hoyos had to return the headwear but expressed a desire to use it again if it becomes available in the US. Dr. Fu mentioned that when her team initially explored transcranial direct current stimulation for depression, they reviewed existing medical literature, which showed the technology's effectiveness but only in clinical settings. Recognizing the need for a more accessible and routine application, they developed a new protocol for home use and tested its efficacy. The study demonstrated that individuals could safely and effectively use the technology independently, without the need for clinical supervision. Dr. Fu believes the device could potentially become a first-line treatment for depression or serve as a supplementary treatment for those who feel their medication is insufficient.

The duration of the device's effects remains unclear. After the initial 10-week phase, the study was unblinded, allowing those in the placebo group to use the active headwear for an additional 10 weeks, extending their active participation to approximately five months. Follow-up checks with participants were conducted at three and six months post-study to assess their ongoing well-being, with the results pending publication. Mansson from Flow Neuroscience noted that while the device has not been specifically studied for certain types of depression, such as seasonal affective disorder or postpartum depression, it is approved for major depressive disorder in Europe and can be used to treat these subtypes.

The device appears to be quite safe, with no serious adverse events reported in clinical trials. However, certain individuals should exercise caution and consult with their physicians before using the device, including pregnant women, those under 18, individuals experiencing suicidal thoughts, those who have had a stroke, people with a history of epilepsy or seizures, individuals who have undergone brain surgery or have metal implants in their head, those with skin conditions affecting the forehead, and anyone with bipolar disorder. De Hoyos reported noticing some minor positive effects from the device and expressed a wish to have used it for a longer period, feeling that she was close to a breakthrough just before the study ended and hoping for further improvement with extended use.