Would you zap your brain to treat depression?
In December, the Food and Drug Administration cleared a device that uses mild electrical currents to stimulate the brain, marking a shift in how the condition could be treated. Known as transcranial direct-current stimulation, or tDCS, the technology is designed for at-home use, potentially offering a more accessible alternative to traditional therapies, according to The New York Times.
The approval applies to a headset made by Swedish company Flow Neuroscience, which has been studying the approach for years. While tDCS itself has existed for more than two decades and has been available in England since 2019, the FDA’s decision gives the treatment new legitimacy in the U.S., where it had largely existed on the fringes of wellness products.
“It legitimizes the therapy itself as a medical therapy, and not just something sold online for wellness or enhancement,” Anna Wexler, an assistant professor of medical ethics at the University of Pennsylvania who studies do-it-yourself brain stimulation, told the Times.
The device works by delivering a weak electrical current to the brain, lowering the threshold for neurons to fire and potentially improving communication between brain regions. That approach reflects a broader shift in how scientists understand depression, as not just a chemical imbalance, but as a disorder tied to disrupted neural connectivity.
For decades, treatment has centered on selective serotonin reuptake inhibitors, or SSRIs, which became dominant in the late 1980s. Today, roughly one in six Americans takes an antidepressant, according to a report. But some researchers say tools like tDCS could push psychiatry beyond its reliance on medication.
“Our brains are so pharmaceutically inclined,” Mark George, of the Medical University of South Carolina, where he is a leading expert in neuromodulation, told the Times.
Rather than altering brain chemistry as medication does, the device directly stimulates neural activity, what George described more simply as trying “to get into the brain and tickle neurons.”
Some clinicians are already seeing potential. Somayya Kajee, a psychiatrist in Norwich, England, said she has used the device to help patients reduce or avoid antidepressants altogether, including those with ADHD or autism who were hesitant to add another medication, the Times reported.
Still, enthusiasm around tDCS has been tempered by inconsistent results. “There’s some positive, but they weren’t overwhelming. They weren’t a slam dunk,” George said. Further, a 2024 study led by Andre Brunoni found that at-home use of the Flow device was no more effective than a surprising placebo: internet browsing, the Times reported.
Even the trial that led to FDA approval showed mixed results. In the so-called Empower study, 174 participants with moderate to severe depression self-administered the treatment at home. By the end, 58% of those using the device showed improvement, compared with 38% in the control group, while 45% reached full remission versus 22% of controls.
But regulators noted “a moderate level of uncertainty of benefit,” in part because participants could often tell whether they were receiving the real treatment.
The approval also comes with limits. The FDA did not authorize the device for patients with treatment-resistant depression, those who have already failed multiple therapies. Instead, it is positioned as a first-line option, either alone or alongside medication, according to the Times.
Unlike electroconvulsive therapy, introduced in 1938 and still considered the gold standard for severe cases of depression, tDCS uses far weaker stimulation. And while transcranial magnetic stimulation has gained traction in recent years, it typically requires expensive, in-office visits.
By contrast, tDCS is designed for accessibility, a relatively low-cost, at-home option that could broaden who gets treated and how.
“We’re just scratching the surface of what’s going to be possible,” Sarah Holly Lisanby, who directs psychiatry and behavioral sciences at Duke University, told the Times.
—Leila Sheridan, News Writer
This article originally appeared on Fast Company’s sister website, Inc.com.
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