Neurological Features During COVID19 (NeuroSARS)

Description of neurolOgical Involvement Observed During SARS COV2 Infection

Description of the neurological impairment: clinico-radiological and electrophysilogical correlations

Study Overview

• Status: Unknown
• Conditions: Encephalitis
• Intervention / Treatment: Other: Observation

Detailed Description

Describe short and long term clinical radiological and electrophysilogical presentations of neurological damage central and peripheral SARS COV2 infection Describe the association between neurological, respiratory and dysautonomic Determine the prognosis of neurological damages to short and long term.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: David Orlikowski, MD PhD; Phone Number: 0147107777; Email: david.orlikowski@aphp.fr
• Study Contact Backup: Name: Isabelle BOSSARD

Study Locations

• France
  • Garches, France, 92380
    • Recruiting
    • Hôpital Raymond Poincaré
    • Contact: DAVID ORLIKOWSKI, MD PHD; Phone Number: (33)147107777; Email: david.orlikowski@rpc.aphp.fr
    • Contact: Phone Number: (33)147104469
    • Principal Investigator: DAVID ORLIKOWSKI, MD PHD
    • Sub-Investigator: Eric Azabou, MD
    • Sub-Investigator: Marie Christine Durand, MD
    • Sub-Investigator: Robert Carlier, MD PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Population hospitalized in ICU for COVID 19.

Description

Inclusion Criteria:

• PCR SARS COV2 positive or CT Scan
• Central neurological signs such as confusion, epilepsy, abnormal movement, pyramidal signs, motor or sensory deficit, involvement of cranial pairs (such as anomie or ageusia) or peripheral.
• Dysautonomic signs such as hypotension or hypertension, bradycardia or tachycardia, hypothermia, SIADH not explained by therapy or a pathology other than SARS COV 2 infection

Exclusion Criteria:

• Contraindication to performing an MRI scan
• Minor
• Pregnant woman
• No follow-up possible at 6 months

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary	incidence of objective neurological damage	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary	incidence of clinical neurological damage incidence of radiological neurological damage incidence of neurophysiological neurological damage	6 months

Collaborators and Investigators

• Sponsor: Centre d'Investigation Clinique et Technologique 805

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2020
• Primary Completion (Anticipated): July 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: dysautonomia; Cranial nerves; brainstem
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Encephalitis
• Other Study ID Numbers: Brain COVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No