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

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04546737
Collaborator
(none)
20
1
19.7
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Magnetic Resonance Spectroscopy (MRS).
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients
Actual Study Start Date :
Sep 8, 2020
Actual Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
May 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Variation from baseline of MRI radiological semiology in COVID-19 patients [9 months after patient inclusion]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Amiens Amiens France 80480

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT04546737
Other Study ID Numbers:
  • PI2020_843_0087
First Posted:
Sep 14, 2020
Last Update Posted:
Nov 3, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire, Amiens
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 3, 2021