Exploring Brain Damages After COVID-19 Infection

SARS-CoV 2 Clinical Trial

— BRAINCOV  

Official title:

Exploring Brain Damages After COVID-19 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04405986
• Other study ID #: CHUBX 2020/20
• Status: Completed
• Phase: N/A
• Start date: May 19, 2020
• Est. completion date: March 10, 2021

Study information

• Verified date: April 2021
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 10, 2021
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• SARS-CoV 2

Intervention

Procedure:
• Auditory Evoked Potentials (AEP)
Record of electrophysiological responses (Auditory Evoked Potentials or AEP) during auditory stimulations with an electroencephalogram (EEG).
• 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)).

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

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