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

Covid19 Clinical Trial

— NSpectroCovid  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04546737
• Other study ID #: PI2020_843_0087
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: July 2023

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: July 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Damage
• Brain Injuries
• COVID-19
• Covid19
• Neurologic Manifestations
• Neurological Manifestations

Intervention

Other:
• Magnetic Resonance Spectroscopy (MRS).
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.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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