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US approves first brain-stimulation device to treat depression at home

FDA clears wearable headset after trial shows meaningful symptom relief

US approves first brain-stimulation device to treat depression at home
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© Reuters

StarsInsider
12/12/2025 08:15 ‧ 1 hour ago | StarsInsider

HEALTH

Psychology

The Food and Drug Administration (FDA) has approved a new device designed to treat depression by delivering a mild electrical current to a brain region involved in regulating mood.

Created by Flow Neuroscience, the headset targets the dorsolateral prefrontal cortex using a technique called transcranial direct current stimulation (tDCS). The method has drawn mixed reactions: a 2023 Lancet study found no advantage over placebo, while other research, including trials backed by the company, has reported positive effects.

The FDA’s decision relied largely on a 2024 phase 2 trial of 174 participants. Those who used the headset for 30 minutes a day over 10 weeks saw significantly greater symptom improvement compared with those who did not use the device.

Depression, whether major depressive disorder, treatment‑resistant, or bipolar, remains one of the world’s leading causes of disability. For decades, first‑line antidepressants have offered only partial relief, often taking weeks to show effect. That gap has fueled growing interest in faster, more innovative approaches, including nitrous oxide, better known as “laughing gas."

Curious? Click through the gallery to discover how the story of depression treatments is evolving.

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