US approves first device to treat depression with at-home brain stimulation
The FDA has approved a device that aims to treat depression by sending electrical currents to the part of the brain known to regulate mood.
For the first time, the U.S. Food and Drug Administration this week approved a brain stimulation device designed to treat depression at home. The approval of the first such device for home depression treatment expands therapeutic options for depression beyond medications.
Manufactured by Flow Neuroscience, the device is worn as a headset that delivers an electrical current to a part of the brain called the dorsolateral prefrontal cortex, which is thought to be involved in mood disorders and depression. There is doubt over a technique known as transcranial direct current stimulation (tDCS). A 2023 test published in Knife Other investigations, including tDCS, found that tDCS is no better than placebo for treating depression. Trial funded by Flow NeuroscienceHas shown some benefits.
The key to FDA approval was a 2024 Phase 2 trial involving 174 people. Participants who wore the headset for 30-minute sessions for 10 weeks experienced significant relief from their depression symptoms compared to participants who did not use the headset. one in document summarizing data Supporting its decision, the FDA said that the benefit of the headset, “although modest, is sufficient to outweigh its potential risks.” The agency pointed to headaches and skin irritation among the potential dangers of the device.
On supporting science journalism
If you enjoyed this article, consider supporting our award-winning journalism Subscribing By purchasing a subscription, you are helping ensure a future of impactful stories about the discoveries and ideas shaping our world today.
“FDA approval of Flow is a historic moment for the treatment of depression: the first step in moving from pharmaceutical treatments to technology-based treatments with minimal side effects,” said Erin Lee, CEO of Flow Neuroscience. a recent statement,
The FDA approval will make the headset available on prescription for the treatment of moderate to severe major depressive disorder in adults. The company is in talks with health insurance providers on possible coverage for the device, which is expected to cost between $500 and $800. reuters,
It’s time to stand up for science
If you enjoyed this article, I would like to ask for your support. scientific American He has served as an advocate for science and industry for 180 years, and right now may be the most important moment in that two-century history.
i have been one scientific American I’ve been a member since I was 12, and it’s helped shape the way I see the world. Science Always educates and delights me, and inspires a sense of awe for our vast, beautiful universe. I hope it does the same for you.
if you agree scientific AmericanYou help ensure that our coverage focuses on meaningful research and discovery; We have the resources to report on decisions that put laboratories across America at risk; And that we support both emerging and working scientists at a time when the value of science is too often recognised.
In return, you get the news you need, Captivating podcasts, great infographics, Don’t miss the newsletter, be sure to watch the video, Challenging games, and the best writing and reporting from the world of science. you can even Gift a membership to someone.
There has never been a more important time for us to stand up and show why science matters. I hope you will support us in that mission.
