Exploring Brain Damages After COVID-19 Infection

Not Applicable

Completed

• Conditions: SARS-CoV 2
• Interventions: Procedure: Auditory Evoked Potentials (AEP); Procedure: Blink and Masseter Inhibitory Reflex

• Registration Number: NCT04405986
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2020-05-08
• Study Start: 2020-05-19
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-28
• Primary Completion: 2021-03-10
• Study Completion: 2021-03-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-07
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electrophysiological procedure	Auditory Evoked Potentials (AEP)	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
Electrophysiological procedure	Blink and Masseter Inhibitory Reflex	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

Primary Outcome Measures

Name	Time	Method
Duration of silent period	Inclusion (T0)	Duration of silent period while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)
Latency of electrophysiological response	Inclusion (T0)	Latencies of electrophysiological responses with Auditory Evoked Potentials
Delay of Muscle contraction	Inclusion (T0)	Delay of Muscle contraction (Blink reflex)
Delay of silent period	Inclusion (T0)	Delay of silent period while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)
Inhibition rate	Inclusion (T0)	Inhibition rate while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France