FDA

FDA approves first at‑home neuromodulation therapy for adults with depression

January 15, 2026

Brand name: Proliv™Rx

Manufacturer: Neurolief Inc.

Approval date: January 12, 2026

FDA has granted premarket approval for Proliv™Rx, the first prescription, at‑home brain neuromodulation system for adults with major depressive disorder (MDD) who did not achieve adequate improvement with at least one antidepressant. The device delivers noninvasive electrical stimulation to occipital and trigeminal nerve pathways to modulate brain circuits involved in mood regulation.

Neurolief anticipates U.S. availability of Proliv™Rx in early 2026 through authorized prescribers, with initial rollout targeting integrated care and behavioral health programs for patients with inadequate antidepressant response.

Efficacy

Approval was supported by the MOOD trial (NCT04279522), a randomized, controlled study of 124 adults with MDD and inadequate antidepressant response. After eight weeks, patients using Proliv™Rx had a mean HDRS₁₇ score reduction of 8.62 points compared with 6.01 points in the sham group (p = 0.0196). Remission rates were 21.3% for active treatment vs. 6.0% for sham (p = 0.027). In an open‑label extension to 16 weeks, Hamilton Depression Rating Scale (HDRS₁₇) reduction reached 9.78 points, and remission rates increased to 31.7%, indicating sustained benefit.

Safety

Proliv™Rx was generally well tolerated. The most common adverse event was headache. No systemic adverse effects were reported.

Sources:

Neurolief receives FDA PMA Approval for First At-Home Brain Neuromodulation Therapy for Adults Whose Depression Was Not Adequately Improved by Antidepressants. [News release]. 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

Carpenter LL, et al. (2025, Sep-Oct). Brain Stimul. 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. https://pubmed.ncbi.nlm.nih.gov/40886913/