NETANYA, Israel & TAMPA, Fla.--(BUSINESS WIRE)--Neurolief Ltd., a neurotechnology innovator, today announced enrollment of the first patient in its pivotal clinical study evaluating Relivion® DP for the treatment of major depressive disorder (MDD). The Relivion DP is the first non-invasive, multi-channel brain neuromodulation system for at home treatment of neurological and neuropsychiatric disorders. The trial, MOOD, will assess the safety and efficacy of Relivion DP as an adjunctive treatment to pharmaceutical management of MDD in adults who have not achieved satisfactory improvement from antidepressant medications. The first patient was enrolled at Butler Hospital, Brown Department of Psychiatry and Human Behavior, Providence, RI.
“With treatment-resistant depression, many people struggle to find the medication that works for them, while others never respond to standard treatments,” said Linda Carpenter, MD, a Professor of Psychiatry and Human Behavior in the Warren Alpert Medical School at Brown University and principal investigator of the trial. “The Relivion DP device offers a promising and convenient non-pharmacological solution with the potential to address the unmet needs of patients who do not respond to traditional therapies.”
The MOOD trial is designed as a prospective, multi-center, two-arm, double-blind, randomized controlled trial, followed by an open-label active treatment phase. The study’s primary endpoint will assess changes in depressive symptoms, from baseline to 8 weeks post-treatment initiation when using Relivion DP, compared to the control group, in subjects suffering from MDD. The severity of depressive symptoms will be assessed by the Hamilton Rating Scale for Depression.
“I see daily the toll depression takes on patients, who often feel hopeless after failing several therapeutic options,” said Dr. Carpenter. “Many do not have the ability to access other neuromodulation therapies which require frequent visits to specialized clinics. We are thrilled to enroll the first patient in the MOOD trial assessing Relivion DP. There is a collective feeling of excitement and hope for this new treatment approach. It has the potential to be a life-changing and convenient option for patients whose symptoms do not improve with antidepressants alone.”
Relivion DP, which is worn as a headset, is designed to treat major depression by stimulating the release of neurotransmitters in the brainstem and modulating brain networks associated with mood control. Utilizing three adaptive output channels, the device transfers mild electrical pulses to the brainstem via six branches of the occipital and trigeminal nerves, which are used as conductors of the electrical stimulation also to higher brain regions involved in mood, anxiety and attention disorders. Part of a disease management system, the Relivion DP device is used in tandem with its dedicated smartphone app and a cloud database to allow physicians to remotely monitor patients, analyze their data, and personalize treatments in ways that will enhance treatment outcomes.
MDD is a serious condition that can affect people's ability to sleep, work, eat, and go about their daily lives. Symptoms and severity vary and may include persistent feelings of sadness, hopelessness, or tension; changes in sleep, appetite, or weight; difficulty concentrating; general lack of interest; and thoughts of death or suicidei.
The FDA granted Breakthrough Device designation to Relivion DP in August 2020. The Breakthrough Devices Program was established by the FDA to provide patients and healthcare providers with timely access to transformative technologies by speeding the development, assessment, and review of innovative medical devices.
Dedicated to bringing relief to patients suffering from chronic neurological and neuropsychiatric disorders, Neurolief is creating a digital therapeutics platform of wearable clinically proven neuromodulation solutions. This technology, which is made to be worn like a headset, is intended to offer highly effective, safe treatment options that work with current pharmaceutical therapies or may provide an alternative to these therapies. It is designed to concurrently neuromodulate major neural pathways in the head and thereby affect brain regions that are involved in the control and modulation of mood and pain. Neurolief’s technology is currently being utilized for patients with migraine and investigated in patients with major depression, future indications may include insomnia, ADHD and additional chronic pain and neuropsychiatric disorders. The company is based in Israel, with US operations in Tampa, FL and is made up of highly experienced professionals with a proven track record in neurosciences, neuromodulation technology and the neurotech devices industry.
i National Institute of Mental Health. Depression. Available at: https://www.nimh.nih.gov/health/topics/depression/. Accessed August 4, 2021.