A New Headset to Help With Depression Is Now Available in the US

With roughly one in six American adults taking an antidepressant medication, Swedish firm Flow Neuroscience is positioning its device as an alternative to traditional drugs. But at the current four-figure price tag, it might take a while for the futuristic-looking headset to catch on with patients. Worn on the forehead for 30 minutes a day and operated with an app, the device provides low-intensity electrical stimulation to the left frontal lobe of the brain, an area involved in regulating mood and emotions. People with depression tend to have lower activity and weaker neural connections in that part of the brain. Flow received approval from the Food and Drug Administration last December, and its device is among a new breed of wearables that monitor, record from, or stimulate the brain. California-based Cognixion, for instance, has modified the Apple Vision Pro to build a communication system for paralyzed people that doesn’t depend on speech or motor control. A headband by Muse promises to improve meditation, and a device by Elemind is meant to help people fall asleep faster. The Flow device targets the same part of the brain as transcranial magnetic stimulation, or TMS, an approved treatment for depression that uses magnetic fields to activate neurons. With TMS, patients have to go to a clinic, and a full dosing series typically requires treatment sessions administered five days a week over several weeks. The whole course of treatment can cost up to $15,000 without insurance. Flow CEO Daniel Månsson, a clinical psychologist before he cofounded the company, says he set out to make a more convenient option for patients. “In order to have a real impact on the problem, you need to create something that has the effect on the brain needed, but that can be used in a home environment in a safe and effective way,” he says. In a trial of 174 people with major depressive disorder, 45 percent of participants who received Flow’s device experienced a remission in symptoms at 10 weeks compared to 22 percent of those in a control group who received a sham version. The trial included people who were taking antidepressants and those who weren’t—evidence that the device can, under medical supervision, be used in addition to medication, Månsson says. Reported side effects were mild: Some people experienced skin irritation, headaches, and trouble concentrating. Antidepressants, meanwhile, can cause nausea, weight gain, drowsiness, dry mouth, and sexual problems, but these can go away a few weeks after beginning medication. In Europe, where the device has been approved since 2019, more than 65,000 people have used the Flow device, says Månsson. The UK’s National Health Service is also piloting the headset. In the US, patients will be able to get a prescription for the Flow device from a clinician in person or via telehealth. But at least for now, they’ll have to pay out of pocket to use it: $2,200 for 10 weeks and then $325 per month after. That’s a lot more than standard antidepressants, which are usually covered by insurance. Månsson says the company is working to get reimbursement from insurers. Vinod Khosla, a billionaire venture capitalist and an early investor in Flow, thinks a nonchemical approach to treating depression is the way of the future. “My bet is, if you ask any person who's on depression drugs, they'd prefer not to be on them,” he says. “They'd like a nondrug, nonchemical treatment for it.”

Source: Wired