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Exploring Brain Damages After COVID-19 Infection (BRAINCOV)

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ClinicalTrials.gov Identifier: NCT04405986
Recruitment Status : Completed
First Posted : May 28, 2020
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
Although direct evidence is currently lacking, the high identity between SARS-CoV-1 and SARS-CoV-2 suggests, that the latter viral strain could also infect the Central Nervous System (CNS). Indeed, some cases of SARS-COV2 encephalitis begin to be described and CNS damages are increasingly highlighted in the literature, but still not objectified by imaging and do not allow to explain the entire clinical patterns. We hypothesise that these CNS damages are not always objectified by Magnetic Resonance Imaging (MRI) but could be indirectly observed by a physiological dysfunction of neural conduction in the brainstem. We will explore brainstem disruption through an electrophysiological approach.

Condition or disease Intervention/treatment Phase
SARS-CoV 2 Procedure: Auditory Evoked Potentials (AEP) Procedure: Blink and Masseter Inhibitory Reflex Not Applicable

Detailed Description:
Clinical and preclinical data from studies with other coronaviruses suggest an evident neurotropism, which may result in more complex clinical scenarios. Can the SARS-CoV-2 enter the Central Nervous System (CNS) and infect neural cells ? And if yes, how the CNS damage contributes to pathophysiology of the COVID-19, to its signs, symptoms and progression as well as to its sequelae. It has been demonstrated that coronaviruses such as SARS-CoV and MERS-CoV do not limit their presence to the respiratory tract and frequently invade the CNS. The intranasal administration of SARS-CoV-1 or MERS-COV resulted in the rapid invasion of viral particles into the brain of mice, possibly through the olfactory bulb via trans-synaptic route. The brainstem, which hosts the respiratory neuronal circuit in the medulla, was severely infected with both types of viruses, which may contribute to degradation and failure of respiratory centres.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Exploring Brain Damages After COVID-19 Infection
Actual Study Start Date : May 19, 2020
Actual Primary Completion Date : March 10, 2021
Actual Study Completion Date : March 10, 2021

Arm Intervention/treatment
Experimental: Electrophysiological procedure
Brainstem reflexes and neural conduction will be explored using Auditory Evoked Potentials (AEP) and blink and Masseter Inhibitory Reflex (MIR) in hospitalised patients with COVID infection
Procedure: Auditory Evoked Potentials (AEP)
Record of electrophysiological responses (Auditory Evoked Potentials or AEP) during auditory stimulations with an electroencephalogram (EEG).

Procedure: Blink and Masseter Inhibitory Reflex
Electrophysiological exploration while stimulating trigeminal nerve to record 1) motor response induced (muscle contraction delay (Blink)) of the facial nerve, or 2) the contraction inhibition of masseters (Masseter Inhibitory Reflex (MIR)).




Primary Outcome Measures :
  1. Latency of electrophysiological response [ Time Frame: Inclusion (T0) ]
    Latencies of electrophysiological responses with Auditory Evoked Potentials

  2. Delay of Muscle contraction [ Time Frame: Inclusion (T0) ]
    Delay of Muscle contraction (Blink reflex)

  3. Delay of silent period [ Time Frame: Inclusion (T0) ]
    Delay of silent period while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)

  4. Duration of silent period [ Time Frame: Inclusion (T0) ]
    Duration of silent period while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)

  5. Inhibition rate [ Time Frame: Inclusion (T0) ]
    Inhibition rate while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria :

  • Age ≥ 18 years.
  • Hospitalized patient suffering from a positive COVID 19 diagnosed by Reverse transcription polymerase chain reaction (RT-PCR) or chest computed tomography scan (CTscan) with specific lesions

Exclusion Criteria :

  • History of neurological damage interfering with auditory evoked potentials (PEA) and Electromyography (EMG) reflexes of the brainstem (stroke of the brainstem, acoustic neuroma, amyotrophic lateral sclerosis, facial diplegia, damage to nerves V or VII, etc.)
  • Impaired alertness
  • Sedative treatments or treatments that disturb nerve conduction.
  • Pregnancy or breastfeeding
  • Individuals under legal protection or unable to express personally their consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405986


Locations
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France
CHU de Bordeaux
Bordeaux, France, 33 076
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Bertrand Glize bertrand.glize@chu-bordeaux.fr
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04405986    
Other Study ID Numbers: CHUBX 2020/20
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
COVID-19
Brainstem
Electrophysiology
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries