Nervous System Symptoms Associated With COVID 19

NCT ID: NCT04922905

Last Updated: 2021-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-02

Study Completion Date

2021-04-02

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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NEURO +

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

Group Type OTHER

NEURO +

Intervention Type 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 + 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.

NEURO -

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

Group Type OTHER

NEURO -

Intervention Type 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)

Interventions

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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.

Intervention Type 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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie Rafiq, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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CHU Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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RC31/20/0178

Identifier Type: -

Identifier Source: org_study_id

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