Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients

NCT04546737 | Unknown

• 1 other identifier: PI2020_843_0087
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Viral pandemics, such as HIV and SARS-Cov-V1, have shown that they can lead to acute and / or delayed neurological complications. At the actual context of the pandemic Coronavirus disease 2019 (COVID-19), neurological manifestations seem to be confirmed since in 85% of COVID-19 patients, present neurological symptoms, including anosmia, ageusia, periorbital pain, dizziness, fatigue, even moderate headache, moderate memory and/or behavioral disorders. However, these neurological manifestations are not well studied and their radiological features are not well described. It is therefore important to assess these potential neurological complications in COVID-19 patients. To the investigator knowledge, there is no previous study in the literature describing spectral brain changes in COVID + patients. Thus, the goal of this work is to describe the radiological semiology using MRI and particularly Magnetic Resonance Spectroscopic (MRS) biomarkers in the evaluation of acute and / or delayed brain damage in COVID + patients presenting a neurological manifestations that are initially related to the cranial nerves damage.

Conditions

Covid19; Neurological Manifestations; Brain Damage

Keywords

Covid19; Neurological Manifestations; MRI and NMR spectroscopy; Radiological semiology; Spectral profile; Brain Damage

Outcome Measures

Primary Outcomes (1)

• Variation from baseline of MRI radiological semiology in COVID-19 patients

  The radiological semiology as described by MRI and particularly Magnetic Resonance Spectroscopic (MRS) biomarkers in the COVID-19 patients presenting neurological manifestations related initially to the cranial nerves damage.

  9 months after patient inclusion

Interventions

Magnetic Resonance Spectroscopy (MRS). OTHER

This is a Nuclear Magnetic Resonance (NMR) technique which can detect the NMR signal allowing to measure under curves areas, amplitudes, ratios and concentrations of various metabolites contained in a biological tissue, in addition to water and lipids. This offers the possibility, in addition to the contribution of MRI imaging, to better characterize pathological processes (inflammatory, infectious, etc.) through spectral and metabolic changes that can be quantitatively evaluated. Spectroscopic measurements will be carried out with a mono-voxel spectroscopy using a PRESS \[Point RESolved Spectroscopy\] sequence with a short Echo Time (TE) of 35 ms, an intermediate TE of 144 ms and a long TE of 288 ms.

Eligibility Criteria

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

You may qualify if:

• Major COVID-19 patient (≥18 years old)
• COVID-19 patient presenting at least one the neurological manifestations:
• anosmia, ageusia, periorbital pain, dizziness, fatigue, moderate headache, moderate memory and behavioral disorders.
• Patient who have signed an informed consent form for the study

You may not qualify if:

• Patient under guardianship or curators or under judicial protection
• Pregnant and breastfeeding women

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

COVID-19; Neurologic Manifestations; Brain Injuries

Interventions

Magnetic Resonance Spectroscopy

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; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 14, 2020
• Study Start: September 8, 2020
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)