Health

A New Hope In Depression Treatment: Home Use Of Brain-Stimulating Devices

KCL

Groundbreaking Research for At-Home Depression Treatment

A recent study in Nature Medicine explores a novel method for managing depression symptoms: a wearable headset that delivers a gentle electrical current. This headset, powered by a 9-volt battery, could potentially alleviate depression symptoms through direct brain stimulation. Researchers observed that among 87 adults with moderate depression who used the headset consistently over a 10-week period, depression symptoms markedly improved compared to a control group wearing an inactive headset. Notably, twice as many participants in the active group reported a remission in depressive symptoms (45%) compared to the placebo group (22%).

“Remission means they don’t have an active mood episode anymore,” said Dr. Rodrigo Machado-Vieira, a psychiatrist and director of the Experimental Therapeutics and Molecular Pathophysiology Program at UTHealth Houston, one of the clinical sites for patient recruitment. In layman’s terms, if patients who achieved remission were to fill out a questionnaire, they might still report mild concerns—such as occasional sleep disturbances or anxiety—yet they wouldn’t meet the clinical threshold for depression.

The study received funding from the device manufacturer but was conducted independently, with funds allocated to a general research account at UTHealth Houston. Machado-Vieira clarified that he held no personal financial interest in the device, underscoring the research’s commitment to impartiality.

The Mechanisms Behind Brain Stimulation for Depression

This innovative headset, designed by Swedish company Flow Neuroscience, is already accessible in the UK, Norway, Hong Kong, and across the European Union. The company has plans to seek regulatory approval from the U.S. Food and Drug Administration (FDA), aiming to introduce this treatment in the United States. Although various brain stimulation devices are already available on the U.S. market, they are primarily marketed for enhancing focus or alertness rather than specifically treating mood disorders. The Flow headset stands out for targeting specific brain regions directly implicated in depression.

Flow Neuroscience’s device works with an app and includes a guided video tutorial, as well as a telemedicine session to ensure correct usage. Two electrodes are precisely positioned to activate the dorsolateral prefrontal cortex, linked with executive function and cognition, and the ventromedial prefrontal cortex, which plays a role in emotional regulation. Research suggests that individuals with depression tend to exhibit less activity in the dorsolateral prefrontal cortex and heightened activity in the ventromedial prefrontal cortex. This imbalance in brain function appears to exacerbate depressive symptoms.

The headset’s mechanism is designed to correct these irregularities. By increasing activity where it’s lacking and reducing it where it’s excessive, the device aims to create a more balanced brain state, explained Daniel Mansson, a clinical psychologist and Flow Neuroscience’s co-founder. “So you’re trying to rebalance the activity,” Mansson said.

The stimulation technique, known as transcranial direct current stimulation (tDCS), uses a low-intensity current to make neurons more responsive. As Dr. Cynthia Fu, a professor at King’s College London and lead investigator of the study, elaborated, “It uses a low current, a small electric current that modulates the action potential of the neuron, so it makes it easier for the neuron to fire or discharge.” She emphasized that, like Dr. Machado-Vieira, she has no financial connection to the device.

Personal Insights: Users Share Their Experiences

Leana De Hoyos, a 34-year-old Houston mother, participated in the study and shared her journey with mental health challenges. A lifelong struggle with executive dysfunction, which impairs the ability to translate intention into action, made her eager to test the Flow headset. “One of the worst symptoms that I have is called executive dysfunction, and that’s where in my head, I want to do something, but physically, I cannot get myself to do it,” she explained. “For whatever reason, I’m just overwhelmed or I just can’t.”

De Hoyos used the device under supervision for 30 minutes per session, while connected to a virtual meeting for observation. She described the sensation as a mix of buzzing, tingling, and mild burning. “If you’ve ever had your hair bleached, it feels like that, weirdly,” she noted. “It’s a little bit of a spicy sensation.”

After several weeks, she noticed improvements in motivation. “The more I did it, the more I noticed that I was a little bit more motivated to actually do things,” she said. Even mundane tasks like tidying her house, which she previously struggled with, became manageable. “I have these things that I call doom piles, which is like a pile of random stuff that you need to put away that you don’t know where it should go,” she shared. After using the headset, she noticed her “doom piles” starting to disappear, a tangible symbol of her improved motivation.

Although De Hoyos had to return the headset at the study’s conclusion, she remains hopeful that it will soon be available in the United States, noting she would readily use it again.

The Path to Home-Based Brain Stimulation

Dr. Fu’s research team initially explored tDCS technology by reviewing existing medical literature. The studies they found showed promise but required the therapy to be administered in a clinical setting, an arrangement that proved impractical for ongoing treatment. Given that regular usage is key for effectiveness, Fu and her team recognized the need to develop a more accessible home-based treatment protocol.

They devised a protocol that could be used independently by patients and tested its feasibility. The study’s results indicate that individuals can safely and effectively administer the treatment from home. Dr. Fu believes this advancement positions the Flow headset as a potential first-line treatment for depression or as a supplementary aid for those who find their medication insufficient.

“People continue to stay well, in general, but it needs to be looked at,” Fu remarked regarding the technology’s long-term effectiveness. Participants in the study remained in the treatment or placebo groups for the initial 10 weeks, followed by an additional 10-week extension where placebo participants switched to the active headset. A three- and six-month follow-up indicated positive results for most participants, although the findings are still awaiting formal publication.

Addressing Safety Concerns and Potential Risks

Flow Neuroscience is committed to safety and has conducted extensive trials, during which no serious adverse effects were reported. However, certain groups should exercise caution or consult medical professionals before using such a device. People who should consider alternative options or seek guidance include:

  • Those who are pregnant
  • Individuals under age 18
  • People experiencing suicidal thoughts
  • Those with a history of epilepsy, seizures, or stroke
  • Individuals with recent brain surgery or metal implants in the skull
  • People with skin conditions, like psoriasis, affecting the forehead
  • Those diagnosed with bipolar disorder

These precautions are standard for brain stimulation devices, ensuring the technology remains safe for a wide range of users. Flow Neuroscience is working to broaden its applicability across various types of depression, including conditions like seasonal affective disorder and postpartum depression. While the device has not been rigorously tested for these subtypes, its approval for major depressive disorder in Europe permits its use for different depression presentations within a clinical framework.

Limitations and Future Possibilities

De Hoyos expressed a desire for longer usage, as she felt she was approaching a breakthrough in her mental health when the study ended. “I felt like I was getting close to a breakthrough right before we were done with the study. I felt like it wasn’t long enough for me,” she said, “I really wanted to do more of it and see, if I did it more, if it would help even more.”

Experts share her optimism, seeing potential for expanded study duration and more varied clinical trials to understand the device’s benefits fully. Researchers also aim to assess how the Flow headset compares to traditional depression treatments, including cognitive-behavioral therapy and medication, to determine its relative efficacy and best use cases.

Looking Forward: Revolutionizing Depression Treatment

As more studies investigate the Flow headset’s effectiveness, its potential to revolutionize depression treatment grows. The appeal of self-administered, non-invasive brain stimulation represents a shift toward more accessible, patient-centered care. In countries where it is already approved, the headset is helping users manage their symptoms independently, offering a hopeful glimpse into the future of mental health treatment. With U.S. regulatory approval pending, many Americans like De Hoyos await the opportunity to experience its benefits.

The Flow Neuroscience headset represents a significant step forward in harnessing science and technology to address mental health challenges. As research continues to validate its safety and efficacy, it could become an invaluable tool in treating depression—whether as a stand-alone option, a first-line treatment, or an effective add-on for patients needing additional support.