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Exploring Brain Damages After COVID-19 Infection (BRAINCOV)

Primary Purpose

SARS-CoV 2

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Auditory Evoked Potentials (AEP)
Blink and Masseter Inhibitory Reflex
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for SARS-CoV 2 focused on measuring COVID-19, Brainstem, Electrophysiology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electrophysiological procedure

Arm Description

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

Outcomes

Primary Outcome Measures

Latency of electrophysiological response
Latencies of electrophysiological responses with Auditory Evoked Potentials
Delay of Muscle contraction
Delay of Muscle contraction (Blink reflex)
Delay of silent period
Delay of silent period while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)
Duration of silent period
Duration of silent period while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)
Inhibition rate
Inhibition rate while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)

Secondary Outcome Measures

Full Information

First Posted
May 8, 2020
Last Updated
April 7, 2021
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT04405986
Brief Title
Exploring Brain Damages After COVID-19 Infection
Acronym
BRAINCOV
Official Title
Exploring Brain Damages After COVID-19 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 19, 2020 (Actual)
Primary Completion Date
March 10, 2021 (Actual)
Study Completion Date
March 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV 2
Keywords
COVID-19, Brainstem, Electrophysiology

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrophysiological procedure
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Auditory Evoked Potentials (AEP)
Intervention Description
Record of electrophysiological responses (Auditory Evoked Potentials or AEP) during auditory stimulations with an electroencephalogram (EEG).
Intervention Type
Procedure
Intervention Name(s)
Blink and Masseter Inhibitory Reflex
Intervention Description
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 Measure Information:
Title
Latency of electrophysiological response
Description
Latencies of electrophysiological responses with Auditory Evoked Potentials
Time Frame
Inclusion (T0)
Title
Delay of Muscle contraction
Description
Delay of Muscle contraction (Blink reflex)
Time Frame
Inclusion (T0)
Title
Delay of silent period
Description
Delay of silent period while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)
Time Frame
Inclusion (T0)
Title
Duration of silent period
Description
Duration of silent period while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)
Time Frame
Inclusion (T0)
Title
Inhibition rate
Description
Inhibition rate while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)
Time Frame
Inclusion (T0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand Glize
Organizational Affiliation
bertrand.glize@chu-bordeaux.fr
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33 076
Country
France

12. IPD Sharing Statement

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Exploring Brain Damages After COVID-19 Infection

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