Top Neurology Investigators from Medical University South Carolina (MUSC) Drive Virtual Clinical Trial Investigating NeuroCOVID

Nov 19, 2020 | CNS, COVID-19, Decentralized Trial, Inflammation, Medical University South Carolina, NeuroCOVID, Neurology, News, Vagus Nerve, Virtual Clinical Trials

Top Neurology Investigators from Medical University South Carolina (MUSC) Drive Virtual Clincial Trial Investigating NeuroCOVID

In addition to the stages (incubation, symptomatic, early pulmonary & late pulmonary) associated with a SARS-CoV-2 infection, known as COVID-19, two observable broader illness-based phases are associated with the virus, including 1) the acute stage and 2) the post-COVID-19 phase. A societal-wide effort to understand the first phase, that is the acute stage, has been intense and ongoing with some progress made. Medical professionals are documenting the disease process, including the symptoms such as fever, heart and lung problems, etc. Some in the medical community are referring to this second phase as “NeuroCOVID.” The medical community (clinic and research) are collaborating more to better understand the latter post-COVID-19 phase involving potential neuropsychiatric symptoms such as fatigue, anxiety and depression as well as other phenomena associated with so-called “long haulers.” An expert team from Medical University of South Carolina (MUSCH) has organized a “decentralized” or virtual clinical trial to investigate possible treatments for this growing, and vexing set of problems associated with COVID-19.

What is NeuroCOVID?

On the first of October, a research team representing multiple academic medical centers from the United States, France and Italy, document in The Lancet evidence of neurological manifestations associated with COVID-19, ranging from mild (headache, hyposmia, ageusia, myalgia and fatigue or sleepiness) to severe (encephalopathy, ischemic and hemorrhagic strokes, seizures, hypoxic-ischaemic brain injury, and Guillain-Barre and other autoimmune syndromes).

Referring to the second phase as “NeuroCOVID,” the team suggests that the patient faces a potential array of problems from the loss of smell to fatigue, headaches and more intense symptoms mentioned.

First a Discussion on Cooperation: A Drive to Consolidate NeuroCOVID Research Efforts

One challenge called out by the researchers is the disparate nature of the evidence or data about NeuroCOVID. With rapid and parallel study efforts as a response to an emergency pandemic situation, the inevitable result the authors report include “…discrepant data elements and definitions of neurological symptoms and signs.” They shared that the preceding combined with “…fragmented scientific approaches and overlapping consortia” revealed that one investigational center can contribute to multiple observational data registries for example.

As a consequence, the European Academy of Neurology (EAN) and the Neurocritical Care Society (NCS) recently endorsed “Global Consortium Studies of Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID)” to hopefully ensure greater scientific rigor while setting the research stage for more efficient and effective global scientific collaboration.

On to a Recently Announced MUSC Effort

Medical University of South Carolina (MUSC) recently announced they were embarking on a study of NeuroCOVID thanks in part to the efforts associated with GCS-NeuroCOVID. An elite global expert in brain stimulation and depression, Mark George, MD as well as nerve stimulation therapy expert Bashar Badran, PhD, (Dr. Badran happens to be a leading researcher in the field of vagus nerve stimulation therapy), and Steve Kautz, PhD, will collaborate together in association with MUSC-housed National Center for Neuromodulation for Rehabilitation Research as well as the Center of Biomedical Research Excellence in Stroke Recovery (COBRE). Both brain stimulation-focused centers are located at the MUSCH College of Health Professions.

What is the Vagus Nerve?

A major element of the autonomic nervous system, the vagus nerve plays an important part in the regulation of metabolic homeostasis, which apparently leads it to influence the neuroendocrine—immune axis involved with the maintenance of homeostasis. This is accomplished according to research referenced from 2014, in part due to its “…afferent and efferent pathways.” Vagus nerve stimulation (SMS) can be stimulated via manual or electric means.  According to Dr. Robert Howland, VNS on the left cervical is an approved therapy for refractory epilepsy and for treatment of resistant depression. Dr. Howland shared in journal of Psychosocial Nursing and Mental Health Services some of the breakthroughs for various neurological-based conditions.

The vagus nerve is a major component of the autonomic nervous system, has an important role in the regulation of metabolic homeostasis, and plays a key role in the neuroendocrine-immune axis to maintain homeostasis through its afferent and efferent pathways. Vagus nerve stimulation (VNS) refers to any technique that stimulates the vagus nerve, including manual or electrical stimulation. Left cervical VNS is an approved therapy for refractory epilepsy and for treatment resistant depression. Right cervical VNS is effective for treating heart failure in preclinical studies and a phase II clinical trial. The effectiveness of various forms of non-invasive transcutaneous VNS for epilepsy, depression, primary headaches, and other conditions has not been investigated beyond small pilot studies. The relationship between depression, inflammation, metabolic syndrome, and heart disease might be mediated by the vagus nerve. VNS deserves further study for its potentially favorable effects on cardiovascular, cerebrovascular, metabolic, and other physiological biomarkers associated with depression, morbidity and mortality.

The Study

The most recent NeuroCOVID study is financed by the National Institutes of Health (NIH)-funded Delaware Clinical and Translational Research Program to address neuroCOVID issues faced by patients, reports Amanda Lawson with MUSC.  The South Carolina-based study starts in late November and will employ a “revolutionary noninvasive technique to stimulate the vagus nerve and reduce inflammation in 20 participants who report having neuroCOVID symptoms.”

The voluntary study invites all age groups and those with a diverse range of health issues who have been experiencing neuroCOVID symptoms. 

Technology Breakthroughs Pave Way for Decentralized Study

One approach to explore for NeuroCOVID involves the triggering of the vagus nerve in subjects but can necessitate a non-patient-friendly procedure. Now with technological breakthrough—largely made possible by Professor Badran—the MUSC investigational team can stimulate the name nerve employing electrical pulses delivered via an earbud device that patients simply insert without ever leaving home!

This is of course part of a broader movement, long predating but accelerated by the COVID-19 pandemic, toward virtual, decentralized studies. Thanks to cloud-based computing models, ubiquitous use of smartphones and other internet-connected devices and a plethora of U.S. Food and Drug Administration (FDA) regulated apps, studies such as this would have involved far more inconvenience to the patient, not to mention discomfort. In fact, this is one reason why the biopharmaceutical industry is bullish on the concept of virtual clinical trials.

In this study, patients will receive a study kit with tablets for video conferencing, an ear stimulator device and other tools (blood pressure, pulse and oxygen saturation level measurement in real time) to support a compelling initiative to better understand neuroCOVID and the potential for stimulation of the vagus nerve.

For more on decentralized studies (e.g. virtual clinical trials) check out some original surveys written exclusively for TrialSite by Joseph Constance.

Lead Research/Investigators

Mark George, MD, professor of psychiatry, radiology and neuroscience (considered a global expert)

Bashar Badran, PhD, assistant professor, College of Medicine

Steve Kautz, PhD, professor and director of the Center of Biomedical Research Excellence in Stroke Recovery

Call to Action: If you are based somewhere near MUSC and interested in participation, or for that matter, if you are a health care professional interested in learning more, contact Sarah Huffman at (843) 792-8672 or email her at [email protected]. If you would like to check in with TrialSite for more study information, feel free to contact us.

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