The first device to treat depression using brain stimulation at home has been approved in the United States.
The FDA has approved a device designed to treat depression by delivering an electrical current to a part of the brain known to regulate mood.
For the first time this week, the US Food and Drug Administration approved brain stimulation device intended for the treatment of depression at home. The approval of the first such device for home treatment of depression expands depression treatment options beyond medications.
The device, created by Flow Neuroscience, is used as a headset that delivers an electrical current to a part of the brain called the dorsolateral prefrontal cortex, which is known to be involved in mood disorders and depression. The technique, known as transcranial direct current stimulation (tDCS), has its skeptics. A 2023 test published in Lancet found that tDCS was no better than placebo for treating depression, while other studies, including research funded by Flow Neurosciencehave shown some benefit.
Key to FDA approval was a 2024 Phase 2 study of 174 people. Participants who wore the headset for 30-minute sessions over 10 weeks reported significant improvements in depressive symptoms compared to a control group that did not use the headset. IN document summarizing data In supporting its decision, the FDA said the benefits of the headset, “although modest, are sufficient to outweigh the potential risks.” The agency cited headaches and skin irritation as possible risks of the device.
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“The FDA approval of Flow is a watershed moment in the treatment of depression: the first step in the transition from pharmaceutical treatments to high-tech treatments with minimal side effects,” said Erin Lee, CEO of Flow Neuroscience, in an interview with the FDA. recent statement.
FDA approval will make the headset available by prescription for the treatment of moderate to severe major depressive disorder in adults. The company is in talks with health insurance providers about possibly insuring the device, which would likely cost between $500 and $800, according to the company. Reuters.
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