FDA Approves ProlivRx, First At-Home Neuromodulation Device for MDD

The US Food & Drug Administration (FDA) has approved ProlivRx, the first at-home, physician-directed brain neuromodulation therapy for adults with major depressive disorder (MDD) who did not respond to ≥ 1 antidepressant.1

Announced by Neurolief on January 12, 2026, the therapy can be delivered at home under physician supervision, eliminating the access and operational challenges of clinic-based treatments.

“Until now, patients struggling with difficult-to-treat depression did not have a non-pharmacological therapy option that could be administered at home,” said Linda Carpenter, MD, co-lead investigator of the MOOD clinical trial and professor of psychiatry at Brown University and director of the Neuromodulation Program at Butler Hospital, in a statement. "Even though there is a tremendous need for new treatment approaches when antidepressant medications aren't working, access to interventional psychiatry services like Transcranial Magnetic Stimulation (TMS) remains limited. Now we can offer our patients ProlivRx therapy with continued medical supervision and the convenience of home use.”

ProlivRx offers focal, multi-channel, external Combined Occipital and Trigeminal Afferent Stimulation (eCOT-AS), applying gentle non-invasive electrical pulses to targeted neural pathways associated with depression. A patient wears a headset with 3 pairs of integrated output electrodes that touch the scalp. The treatment has a low risk of systemic adverse events (AEs).2

“Not only does ProlivRx introduce a novel mechanism for noninvasive neuromodulation through its actions on the occipital and trigeminal neural pathways, but it also establishes a new treatment paradigm by making evidence-based neuromodulation widely accessible, beyond the walls of the specialty clinic,” Carpenter added.

Carpenter and colleagues studied ProlivRx as an adjunctive therapy to antidepressants in the randomized, controlled, multicenter MOOD clinical trial, conducted from September 2021 to June 2024 at 13 clinical centers in the US and Israel.2 The study enrolled adults aged 22 to 70 years with a primary diagnosis of unipolar MDD, confirmed by a Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM), with a current depressive episode duration of up to 3 years.

Participants were randomized 1:1 to the active or sham arm for 8 weeks, followed by an 8-week open-label phase. Compared to sham, patients receiving ProlivRx had significantly greater remission rates (21.3 % vs 6.0 %, P =.027) and more shifts to lower HDRS17 depression severity categories. During the open-label phase, patients receiving ProlivRx had a mean reduction of nearly 10 points (9.78) from baseline on the HDRS17 (P <.0001) and achieved a remission rate of 32%.2

Treatment was well-tolerated with mostly mild and transient AEs. There were no unexpected serious AEs.2 The most common AEs were headache, reported in 5 participants; other events included burning sensation, migraine, and pain & discomfort.

"The ProlivRx pivotal study results represent an important new option for patients who have not responded adequately to medications," said Mark S. George, MD, co-lead investigator of the MOOD trial and professor of psychiatry and neurology at the Medical University of South Carolina.1 "This effective and highly accessible therapy with a favorable safety profile addresses a significant unmet need in this underserved patient population and expands how we can deliver care."

Neurolief anticipates ProlivRx to be available in the US in early 2026 via authorized prescribers, with initial distribution focused on health systems, behavioral health programs, and integrated care settings.1

“ProlivRx was developed to extend brain neuromodulation beyond the limitations of traditional clinic-based care," said Scott Drees, CEO of Neurolief.1 "Patients who don't respond adequately to antidepressants face practical barriers to accessing clinic-based therapy. We are excited to make this therapy available to physicians and their patients."

References

1. Neurolief receives FDA PMA Approval for First At-Home Brain Neuromodulation Therapy for Adults Whose Depression Was Not Adequately Improved by Antidepressants. PR Newswire. Published on January 12, 2026. Accessed on January 13, 2026. https://www.prnewswire.com/news-releases/neurolief-receives-fda-pma-approval-for-first-at-home-brain-neuromodulation-therapy-for-adults-whose-depression-was-not-adequately-improved-by-antidepressants-302658098.html

2. Carpenter LL, George MS, Navarro N, Deutsch L, Leuchter AF. A novel home-based, combined occipital and trigeminal afferent stimulation therapy for major depressive disorder: Efficacy and safety results from a double-blind multicenter randomized sham-controlled study. Brain Stimul. 2025;18(5):1695-1704. doi:10.1016/j.brs.2025.08.022