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OpenTrials
Completed

NCT Number: NCT04922905

Nervous System Symptoms Associated With COVID 19

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 + 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 -

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)

Primary outcomes

  1. percentage of patients in the Neuro + and Neuro- groups

    Time frame: Baseline T0 : inclusion visit

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Nervous System Symptoms Associated With COVID 19 : NS-COV

Acronym: NS-COV

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 11, 2021
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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