Nervous System Symptoms Associated With COVID 19 (NS-COV)

Nervous System Symptoms Associated With COVID 19 : NS-COV

This study aim to prospectively evaluate the neuropsychiatric symptoms of patients infected with the SARS-CoV-2 virus by a standardized neuropsychiatric examination : the global CASE scale (Clinical Assessment Scale in Autoimmune Encephalitis), and the prevalence of disturbances of consciousness, focal neurological deficit, cognitive impairment, headache, anosmia, sleep disturbances, impaired autonomic nervous system and peritraumatic stress.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: NEURO +; Other: NEURO -

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France
    • CHU Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Being hospitalized at the Toulouse University Hospital for a COVID-19 infection proven by a probable PCR or COVID-type examination on the chest scan
• Have given oral consent for the collection of clinical neurological data
• Be in a clinical state compatible with a 30-minute neurological examination
• Be French-speaking
• Be affiliated to a Social Security scheme

Exclusion Criteria:

• Refusal of the neurological examination
• History of neurological pathology at a severe stage
• Pregnant or breastfeeding woman
• Persons with tutors or curators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: NEURO +; Patients "neuro +" are those with a CASE score ≥ 2, "Neuro +" patients will benefit from additional evaluations using paraclinical examinations	Other: NEURO +; The participants will undergo several questionnaires after their classic clinical evaluation allowing to determine the Clinical Assessment Scale in Autoimmune Encephalitis (CASE) score : The dissociative peri-traumatic experiences questionnaire (Birmes et al., 2005); the Peri traumatic distress inventory (Jehel et al., 2005); and the Shortness, Trembling, Racing, Sweating (STRS) (Bracha et al., 2004) Neuro + patients will also have a Brain MRI, cerebrospinal fluid analysis, EEG, as well as an ambulatory sleep recording and electromyography depending on the symptoms observed.
Other: NEURO -; Patients "neuro -" are those with a CASE score < 2	Other: NEURO -; The participants will undergo several questionnaires after their classic clinical evaluation allowing to determine the Clinical Assessment Scale in Autoimmune Encephalitis (CASE) score : The dissociative peri-traumatic experiences questionnaire (Birmes et al., 2005); the Peri traumatic distress inventory (Jehel et al., 2005); and the Shortness, Trembling, Racing, Sweating (STRS) (Bracha et al., 2004)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of patients in the Neuro + and Neuro- groups	The percentage is deducted from the score on a global scale by the Clinical Assessment Scale in Autoimmune Between 0 and 1, patients will be classified in the Neuro group, if this score is greater than or equal to 2, patients will be classified in the Neuro + group.	Baseline T0 : inclusion visit

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Marie Rafiq, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2020
• Primary Completion (Actual): May 7, 2020
• Study Completion (Actual): April 2, 2021

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 11, 2021

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; coronavirus; Nervous system; Nervous system symptoms
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: RC31/20/0178

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