The non-invasive technology, designed for clinic and at-home treatment, could provide a new option for people who previously failed to respond to pharmaceutical treatments.
Neurolief’s double-blind, randomized, placebo-controlled, multi-center clinical trial enrolled 124 patients across multiple centers in the U.S. and Israel. Investigators set a primary endpoint of a reduction in depression severity as measured by the Hamilton Depression Rating Scale (HDRS17).
Key findings include a significant reduction in depression symptoms compared to the control group with Neurolief’s neuromodulation. A substantial portion of patients achieved full remission from depression symptoms as well.
Patients tolerated the therapy well, with no serious adverse events related to the treatment. Approximately 95% of patients fully complied with the daily treatment regimen throughout the 16-week treatment period.
Dr. Linda Carpenter, Professor of Psychiatry and Human Behavior at the Warren Alpert Medical School at Brown University and the principal investigator of the trial, said in a news release: “The results of this clinical trial not only show this technology is safe and effective for relieving depression symptoms, but also that patients can self-administer their therapy in a time and place when it is convenient for them and get better! This will have a tremendous impact on the approach for treating major depressive disorder.”
More about the Neurolief technology
Neurolief designed its technology to stimulate the release of neurotransmitters in the brainstem. It modulates brain networks associated with mood regulation.
Using three adaptive output channels, the device non-invasively transfers electrical pulses to the brainstem through major neural pathways in the head. The pathways conduct the electrical stimulation to the brainstem and higher brain regions involved in depression.
Neurolief designed its technology for at-home treatment with a mobile app and a physician interface. This interface features cloud-enabled data-tracking features and AI integration. The setup allows physicians to monitor patients, analyze their data and personalize treatment, enhancing therapy outcomes.
The technology previously received FDA breakthrough device designation to treat major depression. Neurolief plans to use the trial results to support regulatory submissions in the coming months, followed by approval and commercialization.
“We are dedicated to addressing the unmet needs of patients and their families affected by the debilitating impacts of depression. The success of this pivotal trial not only brings us closer to making this groundbreaking therapy widely available but also highlights the transformative potential of our technology in revolutionizing depression treatment,” said Scott Drees, CEO of Neurolief.
