<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04460599</url>
  </required_header>
  <id_info>
    <org_study_id>Brain COVID</org_study_id>
    <nct_id>NCT04460599</nct_id>
  </id_info>
  <brief_title>Neurological Features During COVID19</brief_title>
  <acronym>NeuroSARS</acronym>
  <official_title>Description of neurolOgical Involvement Observed During SARS COV2 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre d'Investigation Clinique et Technologique 805</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre d'Investigation Clinique et Technologique 805</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Description of the neurological impairment: clinico-radiological and electrophysilogical&#xD;
      correlations&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Describe short and long term clinical radiological and electrophysilogical presentations of&#xD;
      neurological damage central and peripheral SARS COV2 infection Describe the association&#xD;
      between neurological, respiratory and dysautonomic Determine the prognosis of neurological&#xD;
      damages to short and long term.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 8, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Primary</measure>
    <time_frame>6 months</time_frame>
    <description>incidence of objective neurological damage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary</measure>
    <time_frame>6 months</time_frame>
    <description>incidence of clinical neurological damage incidence of radiological neurological damage incidence of neurophysiological neurological damage</description>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Encephalitis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation</intervention_name>
    <description>Observation of recorded neurological signs</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Population hospitalized in ICU for COVID 19.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PCR SARS COV2 positive or CT Scan&#xD;
&#xD;
          -  Central neurological signs such as confusion, epilepsy, abnormal movement, pyramidal&#xD;
             signs, motor or sensory deficit, involvement of cranial pairs (such as anomie or&#xD;
             ageusia) or peripheral.&#xD;
&#xD;
          -  Dysautonomic signs such as hypotension or hypertension, bradycardia or tachycardia,&#xD;
             hypothermia, SIADH not explained by therapy or a pathology other than SARS COV 2&#xD;
             infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to performing an MRI scan&#xD;
&#xD;
          -  Minor&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  No follow-up possible at 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>David Orlikowski, MD PhD</last_name>
    <phone>0147107777</phone>
    <email>david.orlikowski@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Isabelle Bossard</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hopital Raymond Poincare</name>
      <address>
        <city>Garches</city>
        <zip>92380</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>DAVID ORLIKOWSKI, MD PHD</last_name>
      <phone>(33)147107777</phone>
      <email>david.orlikowski@rpc.aphp.fr</email>
    </contact>
    <contact_backup>
      <phone>(33)147104469</phone>
    </contact_backup>
    <investigator>
      <last_name>DAVID ORLIKOWSKI, MD PHD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eric Azabou, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marie Christine Durand, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Robert Carlier, MD PHD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre d'Investigation Clinique et Technologique 805</investigator_affiliation>
    <investigator_full_name>david orlikowski</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Cranial nerves</keyword>
  <keyword>brainstem</keyword>
  <keyword>dysautonomia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Encephalitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04460599
org study id: Brain COVID
nct id: NCT04460599
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Description of the neurological impairment: clinico-radiological and electrophysilogical
      correlations
Describe short and long term clinical radiological and electrophysilogical presentations of
      neurological damage central and peripheral SARS COV2 infection Describe the association
      between neurological, respiratory and dysautonomic Determine the prognosis of neurological
      damages to short and long term.
observational model: Cohort
time perspective: Retrospective
measure: Primary
time frame: 6 months
description: incidence of objective neurological damage
measure: Secondary
time frame: 6 months
description: incidence of clinical neurological damage incidence of radiological neurological damage incidence of neurophysiological neurological damage
intervention type: Other
intervention name: Observation
description: Observation of recorded neurological signs
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: David Orlikowski, MD PhD
phone: 0147107777
email: david.orlikowski@aphp.fr
last name: Isabelle Bossard
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Centre d'Investigation Clinique et Technologique 805
investigator full name: david orlikowski
investigator title: Professor
mesh term: Encephalitis
sharing ipd: No