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临床试验/NCT04405986
NCT04405986终止不适用

Exploring Brain Damages After COVID-19 Infection

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2020年5月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
38
试验地点
2
主要终点
Duration of silent period

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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

干预措施: Auditory Evoked Potentials (AEP) (Procedure)

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

干预措施: Blink and Masseter Inhibitory Reflex (Procedure)

结局指标

主要结局

Duration of silent period

时间窗: Inclusion (T0)

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

Latency of electrophysiological response

时间窗: Inclusion (T0)

Latencies of electrophysiological responses with Auditory Evoked Potentials

Delay of Muscle contraction

时间窗: Inclusion (T0)

Delay of Muscle contraction (Blink reflex)

Delay of silent period

时间窗: Inclusion (T0)

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

Inhibition rate

时间窗: Inclusion (T0)

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

次要结局

未报告次要终点

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

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