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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
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 10, 2020
Last Updated
February 7, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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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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