#USA #Depression #Coral Springs #Neurolief #ProlivRx

Neurolief's Groundbreaking MOOD Study

Neurolief, a pioneering company in neurotechnology, has proudly unveiled the results of its recent MOOD study, presenting a potential breakthrough in the treatment of Major Depressive Disorder (MDD). This landmark trial represents the first major multicenter randomized sham-controlled clinical investigation assessing the safety and effectiveness of its innovative Proliv™Rx therapy for patients who have not responded positively to traditional treatments.

Conducted by a distinguished team of researchers, including Dr. Linda L. Carpenter from Butler Hospital at Brown University, Dr. Mark S. George from the Medical University of South Carolina, and Dr. Andrew F. Leuchter from UCLA, this pivotal study included 160 patients grappling with severe and chronic forms of depression from thirteen clinical sites across the United States and internationally. The research focused on evaluating the impact of the external Combined Occipital and Trigeminal Afferent Stimulation (eCOT-AS) technology on those with hard-to-treat depression.

Key Findings of the Study

The MOOD study yielded several compelling results:

• - Significant Improvement in Symptoms: Patients using Proliv™Rx exhibited marked improvement in their depressive symptoms compared to those receiving sham treatment.
• - Favorable Safety Profile: The therapy was found to have minimal adverse events, showcasing a strong safety record.
• - High Patient Satisfaction: Those participating in home treatment protocols reported high adherence and satisfaction levels, indicating a welcoming reception of this innovative approach.

Scott Drees, CEO of Neurolief, expressed the significance of this publication, stating, “This marks a major milestone for both Neurolief and the mental health field as a whole. The MOOD study validates our commitment to providing effective and accessible neuromodulation therapy for MDD patients. We are nearing the point where Proliv™Rx can be made available to millions who suffer from depression.”

Dr. Linda Carpenter, the Principal Investigator of the study, emphasized the urgency of finding new treatment options for those facing treatment-resistant depression: “Proliv™Rx offers an accessible and effective solution for patients whose depression remains unresponsive to established medications. Many have lived with persistent symptoms for years, and this therapy may significantly augment the mental health treatment landscape.”

Innovative Approach to Mental Health

Neurolief’s Proliv™Rx system, which has obtained FDA Breakthrough Device Designation, features a blend of adaptive stimulation and remote monitoring capabilities via a dedicated app and cloud-based analytics platform. This novel system stands out as the world's first wearable, non-invasive, multi-channel brain neuromodulation device designed for home use—targeting key neural pathways that aid in managing mood and pain.

With its technology currently FDA-approved for migraine treatments, Neurolief is actively pursuing regulatory approvals for Proliv™Rx aimed at treating MDD. If successful, the company will be the first to offer an FDA-approved depression treatment that patients can use at home, outside of clinical settings.

The comprehensive manuscript detailing the study's findings, titled “A Novel Home-Based Neuromodulation Therapy for Major Depressive Disorder: Efficacy and Safety Results from a Multicenter Randomized Sham-Controlled Study,” is set to be published in Brain Stimulation.

For further details and updates about Neurolief's innovative solutions and ongoing efforts, you can visit their official website at www.neurolief.com.