A Smithsonian magazine special report
FDA-Approved At-Home Brain Stimulation Device Aims to Treat Depression by Changing Patients’ Brain Excitability
The treatment consists of a Bluetooth headset that patients can connect to an app on their smartphones. It could mark a revolution in mental health medicine
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Late last year, the U.S. Food and Drug Administration (FDA) approved an at-home brain stimulation device developed by the company Flow Neuroscience, to treat particular cases of major depressive disorder (MDD). The product, Flow FL-100, makes brain stimulation treatments more accessible and represents a milestone in non-pharmacological depression treatment options.
“This is a monumental step forward for the millions of Americans struggling w/ depression. The FDA approval marks the first time in history American clinicians are able to prescribe a novel at-home, non-drug therapy as both a stand-alone and adjunctive treatment for adults w/MDD,” Flow Neuroscience posted on social media shortly after the federal approval.
Flow FL-100 consists of a headset that connects to a smartphone via Bluetooth, where patients use an app that provides guidance, controls the headset and tracks its usage, according to the FDA’s summary of safety and effectiveness data. The headset uses transcranial direct current stimulation (tDCS), meaning it sends low-intensity direct electrical current through electrodes on the scalp to parts of the brain. “The electrical current may modulate neuronal activity by altering the resting membrane potential of cortical neurons, thereby influencing brain excitability,” reads the FDA summary.
Neuromodulation is based on the idea that depression involves impaired neural connectivity, according to the New York Times’ Rachel Gross. Researchers theorize that electrical brain stimulation makes it easier for neurons to fire, contributing to improving the depressed brain’s general functioning.
“Ultimately, we’re trying to get into the brain and tickle neurons,” Mark George, a psychiatrist at the Medical University of South Carolina, tells the Times. He consulted for a home-based brain neuromodulation system that was also approved last year, according to the outlet.
Before the approval of Flow FL-100, the FDA had cleared two other non-invasive brain stimulation treatments for depression, according to an editorial by the journal Brain Stimulation: repetitive transcranial magnetic stimulation (rTMS) and electroconvulsive therapy (ECT), both of which could only be delivered in a clinic, making them significantly less accessible than a treatment that can be carried out at home.
“So, the FDA approval of at-home brain-stimulation expands access and enables treatment for depressed patients who would otherwise be unable or unwilling to receive clinic-based therapies,” the authors write in the editorial.
ECT’s history as a treatment for medical depression dates back decades. Developed in the 1930s in Italy, ECT induces brief seizures in patients under anesthesia. (tDCS, on the other hand, does not induce seizures.) As medical historian Jonathan Sadowsky wrote for The Conversation in 2017, “many psychiatrists, and more importantly, patients, consider it to be a safe and effective treatment for severe depression and bipolar disorder.” This is despite a pronounced stigma among the general public that’s been reinforced by popular culture, such as the 1970s movie One Flew Over the Cuckoo’s Nest.
An influential novel and movie: The power of 'One Flew Over the Cuckoo's Nest'
- Written by counter-culturist Ken Kesey in 1962, the novel was based on Kesey's volunteer work at a Veterans' Affairs hospital and became a key text for the anti-psychiatry movement.
- It was adapted by director Milos Forman in 1975 into a movie that "swept" the Oscars the following year by winning the four major categories, including a Best Actress award for Louise Fletcher who played the film's villain, nurse Mildred Ratched.
- This portrayal, and the film and novel's depiction of psychiatry and ECT as a tool of abuse and control, reflected a societal stigma against the mental health treatment.
The FDA’s green light was mostly due to a 2024 Nature Medicine clinical trial that, according to the researchers, “showed high efficacy, acceptability and safety.” The authors of the editorial, however, point out that the difference in the Hamilton Depression Rating Scale average point reduction between the treatment group (~9) and the sham group (~2) is “sometimes considered below a clinically meaningful difference.”
Flow FL-100 was specifically approved for adults with moderate to severe MDD whose depression has not been resistant to medication such as Prozac. The FDA recommended the device be used either in place of or in conjunction with medication. Side effects, according to the Times, “include ringing in the ears, headaches and mild burns or irritation where the electrode pads touched the forehead.” Erin Lee, Flow Neuroscience’s CEO, told Reuters’ Kamal Choudhury in December that they are aiming for a U.S. retail price of between $500 and $800 when it hits the market later this year.
The device has been approved as a depression therapy in England since 2019.
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