Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients (NSpectroCovid)
Primary Purpose
Covid19, Neurological Manifestations, Brain Damage
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Magnetic Resonance Spectroscopy (MRS).
Sponsored by
About this trial
This is an interventional other trial for Covid19 focused on measuring Covid19, Neurological Manifestations, MRI and NMR spectroscopy, Radiological semiology, Spectral profile, Brain Damage
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patient under guardianship or curators or under judicial protection
- Pregnant and breastfeeding women
Sites / Locations
- CHU Amiens
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04546737
First Posted
September 10, 2020
Last Updated
February 7, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT04546737
Brief Title
Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients
Acronym
NSpectroCovid
Official Title
Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 8, 2020 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Neurological Manifestations, Brain Damage
Keywords
Covid19, Neurological Manifestations, MRI and NMR spectroscopy, Radiological semiology, Spectral profile, Brain Damage
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Magnetic Resonance Spectroscopy (MRS).
Intervention Description
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.
Primary Outcome Measure Information:
Title
Variation from baseline of MRI radiological semiology in COVID-19 patients
Description
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.
Time Frame
9 months after patient inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patient under guardianship or curators or under judicial protection
Pregnant and breastfeeding women
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients
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