Soterix Medical Inc. the global leader in non-invasive stimulation and synergistic brain imaging technologies, announces a new clinical trial of home-based auricular Vagus Nerve Stimulation (taVNS) for individuals who experience post-COVID neuropsychiatric symptoms, like fatigue, headache, or anxiety. The trial involves an innovative, first-of-its kind home-based neuromodulation solution that combines Soterix Medical’s unique wearable taVNS platform, with ElectraRxTM portal for remote stimulation control, and home-based vital sign monitoring.
Emerging studies show COVID can affect patients during two distinct phases of the disease process: the acute stage, characterized by fever, heart or lung problems, and the post-COVID phase, in which neuropsychiatric symptoms, like fatigue, anxiety and depression, can occur.
Researchers have used the term “neuroCOVID” to describe when the second phase is characterized by one or a combination of neuropsychiatric symptoms like vertigo, loss of smell, headaches, fatigue and irritability as well as anxiety and depression. Some studies estimate one in five COVID patients will develop these long-term symptoms.
The study is supported in part by the National Institutes of Health-funded Delaware Clinical and Translational Research Program to address neuroCOVID symptoms in patients. The trial is designed around a unique technology suite that combines precise vagus nerve stimulation with real-time remote-control as well as remote physiological sensing by the clinical team. The trial is based on the established anti-inflammatory response to vagus nerve stimulation.
Mr. Kamran Nazim, Chief Product Manager of Soterix Medical adds, "This study will leverage our unparalleled expertise in developing noninvasive technologies to stimulate the vagus nerve. Soterix Medical has over a decade of experience designing and deploying the more reliable, targeted, and intelligent non-invasive brain stimulation devices. Our proprietary remote-controlled taVNS system is uniquely optimized for this novel indication.”
Ms. Claudia Giselle, Soterix Medical’s VP Regulatory Affairs, adds “In addition to Soterix Medical’s unique wearable vagus nerve stimulation platform, this trial integrates technology for telemedicine support including video and real-time home-based blood pressure, pulse and oxygen saturation levels. The sophistication of this integrated system is a testament to our commitment to provide the most advanced stimulation and integrated monitoring technologies, for the most important medical indications of our time.”
CAUTION: Soterix Medical taVNS platform is limited by Federal (or United States) law to investigational use only.
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