For Americans struggling with depression, a new door has opened: the FDA has authorized the first fully remote at-home brain stimulation treatment, following a study demonstrating its safety and efficacy.

“We’re on a mission to make effective, affordable non-drug treatment available to the millions of Americans suffering from depression,” said Erin Lee, CEO of Flow Neuroscience (Flow).

Brain stimulation treatment for depression

Major depressive disorder (MDD) affects more than 21 million adults in the US alone. Despite the availability of numerous pharmacological treatments, approximately one-third of patients do not respond to antidepressants, and many others discontinue treatment due to debilitating side effects.

In the search for non-drug alternatives, transcranial direct current stimulation (tDCS) has emerged as a promising technology. tDCS involves applying a low-intensity electrical current to the scalp to target specific brain regions. In the case of depression, the goal is to stimulate the dorsolateral prefrontal cortex, an area often hypoactive in people with depression, to encourage normal brain activity.

While the efficacy of tDCS administered in clinics is well known, translating this success to home-based devices has historically proven difficult. Early trials for at-home tDCS were often hampered by methodological flaws and, consequently,  produced mixed or negative results.

Flow, a medical technology company, has developed a headset designed to bridge this gap. Last week, they announced that the FDA has granted approval for its FL-100 device, authorizing it as both a stand-alone and adjunctive treatment for MDD in adults.

“For more than 6 years since the device’s launch in Europe, we’ve been building an evidence base globally with clinical trials, peer-reviewed research and real-world case reports. The approval of FL-100 in the US will now offer millions of patients an accessible and effective non-drug treatment option,” said Daniel Månsson, co-founder and CSO of Flow Neuroscience.

Clinical trial results for at-home brain stimulation treatment

The announcement is in response to Flow’s data from a large Phase 2, multisite, randomized, double-blind, sham-controlled trial conducted in the UK and USA.

The trial recruited 174 participants with moderate-to-severe depression. The cohort included a mix of participants who were medication-free and those currently on stable antidepressant regimens. Participants underwent a 10-week treatment course. To ensure compliance and correct usage, the first session was supervised in real time via video conferencing, followed by strict monitoring of device usage logs throughout the trial.

The results demonstrated a clear clinical benefit. The primary outcome measure, the Hamilton Depression Rating Scale (HDRS), showed that participants in the active stimulation group experienced a mean reduction of 9.41 points, compared to a 7.14 point reduction in the placebo group.

At the end of the 10 weeks, 44.9% of the active group had achieved remission (defined by HDRS scores), compared to 21.8% of the sham group.

Future implications of at-home brain stimulation treatment

By validating a “prescribed digital therapeutic” hardware, this development removes the logistical barrier of daily clinic visits, potentially improving long-term adherence for patients struggling with motivation.

Regarding safety, the device profile was generally favorable, though not without side effects. Reports of skin redness and irritation were significantly higher in the active group compared to the sham group. It is also scientifically relevant to note that two participants experienced burns at the electrode site, a rare adverse event that underscores the importance of correct sponge preparation and protocol adherence.

“Among our real-world users, 77% see improvements in as little as 3 weeks. Such treatment, previously confined to clinics, can now be delivered at home, pointing to a scalable way of expanding access to effective depression care,” said Dr. Kultar Garcha, Flow’s chief medical officer.

However, in the trial, 77.6% of participants in the active group correctly guessed they were receiving the treatment, compared to 59.3% in the sham group. While the authors argue that the clinical benefit remained significant even after accounting for these guesses, the potential contribution of the placebo effect cannot be entirely ruled out.

Despite this, the results align with meta-analyses of clinic-based tDCS, suggesting that the home-based delivery method can potentially be used to treat MDD. Future research will need to assess the durability of these effects beyond the 10-week mark and evaluate efficacy in broader populations.

Flow expects the device to be available in the US as early as Q2 2026.

“Flow’s FDA approval is a watershed moment for the treatment of depression: the first step in moving from pharmaceutical treatments to tech-based therapies with minimal side effects,” said Lee.

“We are committed to ensuring that Flow becomes a part of a standard treatment pathway for depression care. We are singularly focused on helping as many patients as possible achieve remission from depression,” she added.

 

This article is a rework of a press release issued by Flow Neuroscience. Material has been edited for length and content.