Nervous System Symptoms Associated With COVID 19

Covid19 Clinical Trial

— NS-COV  

Official title:

Nervous System Symptoms Associated With COVID 19 : NS-COV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04922905
• Other study ID #: RC31/20/0178
• Status: Completed
• Phase: N/A
• Start date: April 2, 2020
• Est. completion date: April 2, 2021

Study information

• Verified date: June 2021
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: April 2, 2021
• Est. primary completion date: May 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

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.
• 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)

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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