NCT04408391WithdrawnNot Applicable
Descriptive Pilot Study of Brain MRI Imaging in Patients With SARS-Cov2 (COVID-19) Infection With or Without Anosmia
Centre Hospitalier Universitaire de Nīmes1 site in 1 countryStarted: May 20, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Brain regional homogeneity between COVID-19 patients with and without anosmia
Study Overview
Brief Summary
To date there is no brain imaging and olfactory data available in COVID-19 positive patients with anosmia. By describing the pathophysiological characteristics underlying the olfactory symptoms and clinical characteristics of COVID-19 infection, the study investigators wish to compare the MRI aspects obtained in COVID-19 patients with and without anosmia, in the absence of other underlying neurological disorders.
Detailed Description
Brain mapping of COVID-19 patients with or without anosmia will allow better understanding of the mechanisms leading to the onset of these symptoms and will provide a pathophysiological basis for the therapeutic interventions to improve the clinical prognosis of affected patients.
The study investigators hypothesize that in COVID-19 patients witch anosmia the brain mapping objectified by an MRI examination is modified and that there are functional abnormalities in the brain in these patients.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Consecutive adult patients consulting the CAREB or hospitalized at the Nîmes teaching hospital due to COVID-19 infection (fever, persistent cough, tiredness, shortness of breath, diarrhea, abdominal pain, chest pain, sore throat, loss of smell or taste)
- •COVID-19 confirmed by RT-PCR and / or chest CT or clinical characteristics (i.e an epidemic history and 2 clinical manifestations or at least 3 clinical manifestations)
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan "with anosmia" group:
- •scoring < 30 on a VAS 0-100 for olfactory ability
- •Responding "yes" to question "have you lost your sense of smell in the last few days?"
- •Negative result to olfactory test with n-Butanol diluted to 1/
- •"without anosmia" group:
- •scoring < 80 on a VAS 0-100 for olfactory ability
- •Responding "no" to question "have you lost your sense of smell in the last few days?"
- •Positive result to olfactory test with n-Butanol diluted to 1/16000.
Exclusion Criteria
- •Patient suffering from serious medical problems or hospitalized in an intensive care unit for invasive ventilation or severe dyspnea.
- •Patient with neurological (motor, sensitive or cognitive), neuropsychiatric or vascular disorders.
- •Patient with a contraindication to MRI (pace maker, claustrophobic patient, metallic heart valve, etc.).
- •Patient with a history of rhinological pathology or a sense of smell problem.
- •Patient with known neurological, psychiatric or neuroradiological manifestation.The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- •The subject is unable to express consent
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •Patient is pregnant, parturient or breastfeeding
Outcomes
Primary Outcomes
Brain regional homogeneity between COVID-19 patients with and without anosmia
Time Frame: Day 0
MRI; Voxels
Secondary Outcomes
- Ability to detect odor(Day 0)
- Ability to taste a pinch of sugar(Day 0)
- Presence of thrombotic and hemorrhagic lesions(Month 3)
- Presence of lesions with hyperintensity(Month 3)
- Brain regional homogeneity between COVID-19 patients with and without anosmia(Month 3)
- Topography of supra- or sub-tentorial lesions between COVID-19 patients with and without anosmia(Day 0)
- Fractional anisotropy between COVID-19 patients with and without anosmia(Month 3)
- Mean diffusivity between COVID-19 patients with and without anosmia(Month 3)
- Radial diffusivity between COVID-19 patients with and without anosmia(Month 3)
- Self-assessed olfactory and gustatory test(Month 2)
- Projection network analysis of all patients(Month 3)
- Blinded independent component analysis of all patients(Month 3)
- default mode network analysis of all patients(Month 3)
- executive control network analysis of all patients(Month 3)
Investigators
Study Sites (1)
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