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

Primary Purpose

Covid19

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

NEURO +

NEURO -

About this trial

This is an interventional health services research trial for Covid19 focused on measuring Nervous system, coronavirus, SARS-CoV-2, Nervous system symptoms

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

NEURO +

NEURO -

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04922905

First Posted

June 9, 2021

Last Updated

June 9, 2021

Sponsor

University Hospital, Toulouse

1. Study Identification

Unique Protocol Identification Number

NCT04922905

Brief Title

Nervous System Symptoms Associated With COVID 19

Acronym

NS-COV

Official Title

Nervous System Symptoms Associated With COVID 19 : NS-COV

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

April 2, 2020 (Actual)

Primary Completion Date

May 7, 2020 (Actual)

Study Completion Date

April 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

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

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NEURO +

Arm Type

Other

Arm Description

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

Arm Title

NEURO -

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

NEURO +

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

NEURO -

Intervention Description

Primary Outcome Measure Information:

Title

percentage of patients in the Neuro + and Neuro- groups

Description

Time Frame

Baseline T0 : inclusion visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marie Rafiq, MD

Organizational Affiliation

University Hospital, Toulouse

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Toulouse

City

Toulouse

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Nervous System Symptoms Associated With COVID 19

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