Nervous System Symptoms Associated With COVID 19

NCT04922905 | Completed

• 1 other identifier: RC31/20/0178
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19

Keywords

Nervous system; coronavirus; SARS-CoV-2; Nervous system symptoms

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

NEURO +

OTHER

Patients "neuro +" are those with a CASE score ≥ 2, "Neuro +" patients will benefit from additional evaluations using paraclinical examinations

Other: NEURO +

NEURO -

OTHER

Patients "neuro -" are those with a CASE score \< 2

Other: NEURO -

Interventions

NEURO - OTHER

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 -

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

COVID-19; Neurologic Manifestations; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie Rafiq, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an observational, prospective, cross-sectional and monocentric cohort study

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 11, 2021
• Study Start: April 2, 2020
• Primary Completion: May 7, 2020
• Study Completion: April 2, 2021
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)