FDA-Certified At-Home Brain Stimulation Gadget Seeks to Address Depression by Altering Patients’ Brain Excitability
The Evolution of Mental Wellness
A Smithsonian magazine exclusive report
The treatment features a Bluetooth headset that patients can link to an app on their smartphones. It could signify a transformation in mental health therapy
The treatment entails using a headset during multiple at-home sessions.
Flow Neuroscience via Facebook
Late in the previous year, the U.S. Food and Drug Administration (FDA) authorized an at-home brain stimulation device created by Flow Neuroscience to address specific instances of major depressive disorder (MDD). The device, Flow FL-100, enhances accessibility to brain stimulation therapies and signifies an important development in non-drug options for treating depression.
“This is a significant advancement for countless Americans battling depression. The FDA’s endorsement signifies a historic moment, allowing American clinicians to prescribe a unique at-home, non-pharmaceutical therapy as both a standalone and supplementary treatment for adults with MDD,” stated Flow Neuroscience on social media shortly after federal approval.
Flow FL-100 is comprised of a headset that pairs with a smartphone via Bluetooth, where users can access an app that guides them, manages the headset, and monitors its usage, as detailed in the FDA’s report on safety and efficacy data. The device employs transcranial direct current stimulation (tDCS), which means it transmits low-intensity electrical currents through electrodes on the scalp to targeted brain areas. “The electrical current may influence neuronal behavior by modifying the resting membrane potential of cortical neurons, thereby affecting brain excitability,” according to the FDA report.
Neuromodulation is founded on the premise that depression is linked to disrupted neural connections, as highlighted by Rachel Gross from the New York Times. Researchers hypothesize that electrical stimulation of the brain facilitates neuronal firing, thereby helping to improve the overall functioning of a depressed brain.
“In the end, our goal is to penetrate the brain and stimulate neurons,” says psychiatrist Mark George from the Medical University of South Carolina, who consulted on another at-home brain neuromodulation system that received approval last year, according to the Times.
Prior to Flow FL-100’s approval, the FDA had green-lighted two other non-invasive brain stimulation techniques for depression, detailed in an editorial from Brain Stimulation: repetitive transcranial magnetic stimulation (rTMS) and electroconvulsive therapy (ECT), both of which were only available in clinical settings, rendering them far less accessible than a treatment capable of being performed at home.
“Thus, the FDA’s endorsement of at-home brain stimulation broadens access and permits treatment for patients with depression who might otherwise be unable or resistant to engaging with clinic-based therapies,” the editorial authors observe.
The history of ECT as a medical treatment for severe depression stretches back many years. Developed in the 1930s in Italy, ECT brings about brief seizures in patients under anesthesia. (tDCS, by contrast, does not provoke seizures.) As medical historian Jonathan Sadowsky noted for The Conversation in 2017, “numerous psychiatrists, and more crucially, patients, regard it as a safe and beneficial treatment for severe depression and bipolar disorder.” This remains despite a considerable stigma within public perception, bolstered by representations in popular culture like the 1970s film One Flew Over the Cuckoo’s Nest.
A pivotal novel and film: The influence of ‘One Flew Over the Cuckoo’s Nest’
- Crafted by counter-culturist Ken Kesey in 1962, the novel was inspired by Kesey’s volunteer experiences at a Veterans’ Affairs hospital and became integral to the anti-psychiatry movement.
- It was transformed by director Milos Forman in 1975 into a film that “swept” the Academy Awards the following year, securing wins in all four major categories, including a Best Actress accolade for Louise Fletcher, who portrayed the film’s antagonist, nurse Mildred Ratched.
- This representation, along with the film and novel’s portrayal of psychiatry and ECT as instruments of control and abuse, mirrored a societal bias against mental health treatment.
The FDA’s approval was primarily attributed to a 2024 Nature Medicine clinical trial, which, according to the researchers, “demonstrated high efficacy, acceptability, and safety.” However, the authors of the editorial note that the difference in the Hamilton Depression Rating Scale average score reduction between the treatment group (~9) and the sham group (~2) is “sometimes deemed below a clinically relevant difference.”
Flow FL-100 was authorized specifically for adults with moderate to severe MDD whose condition has not proven resistant to treatments like Prozac. The FDA recommended utilizing the device either instead of or alongside medication. Reported side effects include “ringing in the ears, headaches, and mild burns or irritation where the electrode pads made contact with the forehead,” as stated by the Times. Erin Lee, the CEO of Flow Neuroscience, informed Reuters’ Kamal Choudhury in December that they plan for a retail price in the U.S. ranging from $500 to $800 upon its market release later this year.
The device has been recognized as a treatment for depression in England since 2019.