FDA Approves At-Home Neuromodulation Therapy Device for Major Depression
Key Clinical Summary
- FDA approval: Proliv™Rx is the first prescription, physician-directed, at-home brain neuromodulation therapy approved as adjunctive treatment for adults with major depressive disorder (MDD) with inadequate antidepressant response.
- Clinical evidence: Approval was supported by the randomized, controlled, multicenter MOOD Study in patients with MDD who failed at least 1 antidepressant medication.
- Access and delivery: The therapy enables noninvasive neuromodulation at home under physician oversight, addressing access limitations of clinic-based interventions in the United States.
The US Food and Drug Administration has approved Proliv™Rx, a novel at-home neuromodulation therapy as adjunctive treatment for adults with major depressive disorder (MDD) who have not achieved satisfactory improvement with antidepressant medication. Announced January 12, 2026, by Neurolief Inc., the approval is based on promising evidence from the 2025 MOOD Study, a randomized, multicenter clinical trial.
Efficacy Results and Regulatory Decision
Proliv™Rx received Class III Premarket Approval (PMA) for use as an adjunctive therapy for adults with MDD who have failed to respond adequately to at least 1 prior antidepressant medication.
Clinical support for approval came from the MOOD Study, a randomized, controlled, multicenter clinical trial evaluating the safety and effectiveness of Proliv™Rx in patients with inadequate antidepressant response. The study found that Proliv™Rx significantly improved depressive symptoms and remission compared to sham treatment and was well-tolerated, with mild and transient adverse events.
Proliv™Rx delivers focal, multi-channel external Combined Occipital and Trigeminal Afferent Stimulation (eCOT-AS). The therapy applies gentle electrical pulses to neural pathways implicated in depression, specifically targeting occipital and trigeminal afferent pathways. The approach is noninvasive and designed to minimize side effects associated with pharmacologic treatments.
Proliv™Rx is intended for home use under physician direction. This model reduces the need for specialized clinical infrastructure, which can limit patient access to interventional psychiatry services.
Clinical Implications
MDD remains a leading cause of disability, and a substantial proportion of patients do not achieve adequate symptom relief with antidepressant medications alone. For clinicians, the FDA approval of Proliv™Rx introduces a new, evidence-based, nonpharmacological adjunctive option for patients with difficult-to-treat depression.
The at-home design may help address longstanding access barriers associated with clinic-based neuromodulation therapies, including geographic limitations, staffing requirements, and operational costs. By allowing treatment to occur in the patient’s home with continued medical supervision, Proliv™Rx may support broader adoption of neuromodulation earlier in the treatment pathway after medication failure.
Expert Commentary
“The Proliv™Rx pivotal study results represent an important new option for patients who have not responded adequately to medications,” said Mark S. George, MD, professor of psychiatry and neurology at the Medical University of South Carolina in Charleston, South Carolina, and a principal investigator of the MOOD Study, in a news release. He noted that the therapy’s accessibility and safety profile address “a significant unmet need” and expand how clinicians can deliver care.
Linda Carpenter, MD, professor of psychiatry at Brown University and director of the neuromodulation program at Butler Hospital in Providence, Rhode Island, added that Proliv™Rx establishes “a new treatment paradigm by making evidence-based neuromodulation widely accessible, beyond the walls of the specialty clinic.”
Neurolief stated that Proliv™Rx is expected to be commercially available in the United States in early 2026 through authorized prescribers, with an initial focus on health systems, behavioral health programs, and integrated care settings seeking scalable treatment options.
