Neurolief announces the first patient enrolled in a clinical study evaluating its brain neuromodulation system in the treatment of major depressive disorder
NETANYA, Israel & TAMPA, Florida – (COMMERCIAL THREAD) – Neurolief Ltd., a neurotechnology innovator, today announced the recruitment of the first patient in its pivotal clinical study evaluating RelivionÂ® DP for the treatment of major depressive disorder (MDD). The Relivion DP is the first non-invasive multichannel brain neuromodulation system for the home treatment of neurological and neuropsychiatric disorders. The trial, MOOD, will assess the safety and efficacy of Relivion DP as an adjunct to the pharmaceutical management of MDD in adults who have not achieved satisfactory improvement with antidepressant drugs. The first patient was enrolled at Butler Hospital, Department of Psychiatry and Human Behavior in Brown, Providence, RI.
âWith treatment-resistant depression, many people struggle to find the right medication for them, while others never respond to standard treatments,â said Linda Carpenter, MD, professor of psychiatry and human behavior at Brown University’s Warren Alpert Medical School. and principal investigator of the trial. âThe Relivion DP device offers a promising and practical 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, multicenter, two-arm, double-blind, randomized controlled trial, followed by an open-label active treatment phase. The primary endpoint of the study will assess changes in depressive symptoms from baseline up to 8 weeks after starting treatment when using Relivion DP, compared to the control group, in patients with subjects with MDD. The severity of depressive symptoms will be assessed by the Hamilton Depression Rating Scale.
“I see the negative consequences of depression on a daily basis for patients, who often feel hopeless after failing at several treatment options,” said Dr. Carpenter. âMany don’t have the ability to access other neuromodulation therapies that require frequent visits to specialist clinics. We are delighted to enroll the first patient in the MOOD trial evaluating Relivion DP. There is a collective sense of excitement and hope for this new approach to treatment. 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 like a helmet, is designed to treat major depression by stimulating the release of neurotransmitters in the brainstem and modulating brain networks associated with mood control. Using three adaptive output channels, the device transfers mild electrical impulses to the brainstem via six branches of the occipital and trigeminal nerves, which are used as conductors of electrical stimulation also to the upper brain regions involved in mood disorders. , anxiety and attention. As part of a disease management system, the Relivion DP device is used in tandem with its dedicated smartphone app and a cloud database to enable physicians to remotely monitor patients, analyze their data and personalize treatments to improve treatment outcomes.
MDD is a serious illness that can affect a person’s ability to sleep, work, eat, and go about their daily lives. Symptoms and severity vary and can include lingering 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 the Breakthrough Device designation to Relivion DP in August 2020. The Breakthrough Devices program was created by the FDA to provide patients and healthcare providers with rapid access to transformative technologies by accelerating development, evaluation and review of innovative medical devices.
Dedicated to providing relief to patients with chronic neurological and neuropsychiatric disorders, Neurolief creates a digital therapeutic platform of clinically proven portable neuromodulation solutions. This technology, designed to be worn like a helmet, is intended to provide highly effective and safe treatment options that work with current pharmaceutical therapies or can be an alternative to these therapies. It is designed to simultaneously neuromodulate the main neural pathways in the head and thus affect the regions of the brain involved in the control and modulation of mood and pain. Neurolief’s technology is currently being used for patients with migraine and being studied in patients with major depression. Future indications could include insomnia, ADHD, and other chronic pain and neuropsychiatric disorders. The company is based in Israel, with US operations in Tampa, Florida, and is comprised of highly experienced professionals with proven track records in neuroscience, neuromodulation technology, and the neurotechnology device industry.
I National Institute of Mental Health. Depression. Available at: https://www.nimh.nih.gov/health/topics/depression/. Accessed August 4, 2021.