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Research Operations Subcommittee Update 2019-2020

By Currents Editor posted 08-06-2020 10:15

  

By Shraddha Mainali, MD; Molly McNett, PhD, RN, FNCS; Sherry Chou, MD, MMSC, FNCS; Jennifer Kim, MD, PhD; Tom Lawson, CNP

 

The Research Operations Subcommittee (ROSC) of The Neurocritical Care Society (NCS) has continued to support research initiatives throughout the society. Within the past year, the subcommittee has primarily provided operational support for two main projects:

  1. The Curing Coma Campaign (CCC)
  2. The Global Consortium Study of Neurological Dysfunction in COVID-19 (GCS NeuroCOVID).

The Curing Coma Campaign (CCC)

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NCS has taken up the grand challenge to “Cure Coma,” which was officially announced at the NCS 17th Annual Meeting in Vancouver in 2019. The scientific steering committee and the NCS research core (Neurocritical Care Research Network (NCRC), Neurocritical Care Research Network (NCRN)/Mission Control and the ROSC) have continued to work on building the foundation and paving the path to accomplish this colossal mission, despite the unprecedented challenges brought upon by the pandemic.

The ROSC is committed to supporting the CCC by providing logistical support and coordination of various elements of the campaign.  Early in the development of the initial campaign, the ROSC collaborated with NCRN to identify representatives from ROSC to serve within the central coordinating component of CCC, “Mission Control.” Integrating ROSC representation into Mission Control will aid in streamlining communication among various workgroups within the CCC and mobilize additional infrastructure components that may be needed rapidly as the initiative continues to grow. For example, as the CCC began to initiate specific modules and identify individuals with expertise to serve on these teams, the ROSC survey taskforce quickly developed a “call for volunteers” to begin creating a central database of interested volunteers.   Most recently, the ROSC website taskforce has updated the NCS research website to provide specific links to the CCC website and materials.   

Global Consortium Study of Neurological Dysfunction in COVID-19 (GCS NeuroCOVID)

The COVID-19 pandemic continues to surge globally. Within this pandemic, there is an emerging body of literature reporting on various neurological dysfunctions associated with COVID-19 infection. Multiple reports have suggested a spectrum of mild to severe neurological illnesses in patients with COVID-19, including headache, encephalopathy, hyposmia/anosmia, dysgeusia/ageusia, meningitis/encephalitis, seizures, coma, Guillain-Barre syndrome and acute cerebrovascular events.  Neurocritical care teams are uniquely positioned to gather data to better understand the prevalence, mechanisms, phenotypes and prognostic implications of COVID-19-related neurological dysfunctions. Recognizing the existing knowledge gap in areas pertaining to our specialty, a team of neurocritical care experts within ROSC leadership team rapidly developed research protocols to evaluate these gaps in a systematic manner and coordinated with other members of NCS to launch three active studies:

  1. Neurocritical Care COVID 19 Outcomes Study: This prospective, multicenter global observational study aims to evaluate the impact of COVID19 on outcomes of adult neurocritical care patients. This study will focus on five major neurological and neurosurgical conditions managed in the NCCU:
    • Ischemic stroke
    • ICH
    • SAH
    • TBI
    • Status epilepticus

All patients with the relevant diagnoses, regardless of COVID-19 status will be enrolled in the study. To date, there are 83 global sites enrolled in this study. Enrollment is ongoing and interested members can sign up to participate on the NCS COVID Research webpage.            

  1. Global Consortium Study of Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID): Adult Study

The Global Consortium  Study of Neurological dysfunction in COVID-19 (GCS-NeuroCOVID), has been established with the goal of understanding the global prevalence, pathological mechanisms and outcomes of neurological dysfunctions associated with COVID-19.This pragmatic study is designed to be launched in a three-tiered approach with basic prevalence data collection in the first tier and inclusion of more granular details and higher complexity study designs in higher tiers. This approach will allow for adjustment and addition of pertinent new neurological findings in higher tiers as new neurologic manifestations surface over time. As of late July 2020, there are 123 sites, including 44 countries and six continents registered for the Tier 1 study. This study is open for enrollment and interested investigators can register their sites for participation through this portal:

The Tier 2 study consists of prospective collection of functional and cognitive outcomes with greater details of clinical, laboratory and radiographic data performed as part of standard of care. The Tier 3 study involves the high complexity design including collection of experimental biospecimens, such as blood and cerebral spinal fluid (CSF), advanced electrophysiological and imaging analysis, as well as longitudinal outcomes assessment. A team of global experts have been assembled to form scientific working groups to finalize the data elements for Tier 2 and Tier 3 studies, which are currently being finalized.

  1. Global Consortium Study of Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID): Pediatric Study

In parallel to the adult study, a multicenter pediatric core has established a three-tiered pediatric arm to this global research consortium with the aim of capturing prevalence of neurologic dysfunctions in pediatric population, to evaluate specific neurological dysfunctions associated with COVID-19 and to examine patient outcomes related to these dysfunctions.  The Tier 1 pediatric study is active for enrollment through December 2021 and involves data collection from the medical record during the hospital stay. Tier 2 and 3 are actively being developed. To date, 99 sites have registered for the Tier 1 study globally.

The COVID-19 research initiative is endorsed by the NCS and a brief description of all studies with registration links can be found on the NCS website

The GCS NeuroCOVID study team has established a formal partnership with the European Academy of Neurology, expanding the number of registered sites to over 400 locations globally.  Additionally, the project has recently been supported by the Latin American Brain Injury Group (LABIC) to expand access to study materials throughout South America. Members of the study team and ROSC have also been invited to join the Brain Initiative Forum of The World Health Organization to work toward global harmonization of core data elements that will be included in assessments and research regarding neurological manifesations of COVID-19.  Harmonization of core data elements across sites and resource settings through these partnerships is imperative to accurately record data on the prevalence, severity and outcomes associated with COVID-19 infection on a global platform.

For a detailed description of the GCS NeuroCOVID study, please review the methods paper published in the Neurocritical Care Journal.1

Reference:

  1. Frontera J, Mainali S, Fink E, Robertson C, Schber M, Ziai DM, Kochanek PM, Suarez J, Helbok R, McNett M, Chou SH. Global Consortium Study of Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID): Study Design and Rationale. Neurocrit Care UnitedStates; 2020.

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