Exploring Brain Damages After COVID-19 Infection

NCT04405986 | Completed

• 1 other identifier: CHUBX 2020/20
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV 2

Keywords

COVID-19; Brainstem; Electrophysiology

Outcome Measures

Primary Outcomes (5)

• Latency of electrophysiological response

  Latencies of electrophysiological responses with Auditory Evoked Potentials

  Inclusion (T0)

• Delay of Muscle contraction

  Delay of Muscle contraction (Blink reflex)

  Inclusion (T0)

• Delay of silent period

  Delay of silent period while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)

  Inclusion (T0)

• Duration of silent period

  Duration of silent period while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)

  Inclusion (T0)

• Inhibition rate

  Inhibition rate while the patient is asked to tighten the jaws (Masseter Inhibitory Reflex)

  Inclusion (T0)

Study Arms (1)

Electrophysiological procedure

EXPERIMENTAL

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); Procedure: Blink and Masseter Inhibitory Reflex

Interventions

Auditory Evoked Potentials (AEP) PROCEDURE

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

Electrophysiological procedure

Blink and Masseter Inhibitory Reflex PROCEDURE

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)).

Electrophysiological procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33 076, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Evoked Potentials, Auditory; Blinking

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Vestibulocochlear Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Reflex; Ocular Physiological Phenomena

Study Officials

• Bertrand Glize

  bertrand.glize@chu-bordeaux.fr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 28, 2020
• Study Start: May 19, 2020
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

FR (1)