CORAL SPRINGS, Fla., Sept. 9, 2025 /PRNewswire/ — Neurolief, a neurotechnology company, is proud to announce the publication of the MOOD study. This trial is the first pivotal multicenter randomized sham-controlled clinical trial evaluating the safety and efficacy of Proliv™Rx, for Major Depressive Disorder (MDD). The study evaluated this novel neuromodulation therapy for MDD that had not responded well to prior treatment.
The study, recently accepted by the Journal, Brain Stimulation, was conducted by a distinguished team of researchers including Dr. Linda L. Carpenter (Butler Hospital, Brown University), Dr. Mark S. George (Medical University of South Carolina), and Dr. Andrew F. Leuchter (UCLA), among others. It involved 160 patients battling severe and chronic depression across 13 US and international clinical sites. The independent investigators assessed the impact of the technology, classified as “external Combined Occipital and Trigeminal Afferent Stimulation “(eCOT-AS) on hard-to-treat-depression.
Key Findings:
- Significant improvement in depressive symptoms among patients using Proliv™Rx compared to sham controls.
- Favorable safety profile with minimal adverse events.
- High patient adherence and satisfaction with the home-based treatment protocol.
“This publication marks a major milestone for both Neurolief and for the field of mental health,” said Scott Drees, Chief Executive Officer at Neurolief. “The MOOD study validates our vision of delivering effective, accessible, and personalized neuromodulation therapy to patients suffering from MDD. We are now one step closer to making Proliv™Rx available to millions in need.”
Dr. Linda Carpenter, Principal Investigator of the MOOD study, added:
“The need for new treatment options for those battling treatment-resistant depression is urgent and unmet. Proliv™Rx offers an accessible and effective solution for patients whose depression is unresponsive to medications, many of whom have endured years of persistent symptoms. This therapy has the potential to become an essential tool in the mental health treatment landscape.”
The MOOD study builds on Neurolief’s commitment to advancing non-invasive brain therapies. The Proliv™Rx system, which received FDA Breakthrough Device Designation, integrates adaptive stimulation with remote monitoring via a dedicated app and cloud-based analytics platform.
The full manuscript, titled “A Novel Home-Based Neuromodulation Therapy for Major Depressive Disorder: Efficacy and Safety Results from a Multicenter Randomized Sham-Controlled Study,” is in press at Brain Stimulation: https://doi.org/10.1016/j.brs.2025.08.022
About Neurolief
Neurolief is a pioneering neuromodulation company committed to developing breakthrough therapies for mental health and neurological disorders. The company has developed the world’s first wearable, non-invasive, multi-channel brain neuromodulation system, that is designed for home use, engineered to simultaneously stimulate key neural pathways in the head to modulate brain regions involved in the regulation of mood and pain. Neurolief’s technology is currently FDA-cleared and CE-marked for the treatment of migraine, and the company is actively seeking regulatory approvals for Proliv™Rx, its flagship product for the treatment of Major Depressive Disorder. If granted, Neurolief will be the first medical device company to offer an FDA-approved MDD treatment that can be delivered outside of the clinic. Learn more at: www.neurolief.com
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