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Brain MRI Imaging in Patients With SARS-Cov2 (COVID-19) Infection With or Without Anosmia

Descriptive Pilot Study of Brain MRI Imaging in Patients With SARS-Cov2 (COVID-19) Infection With or Without Anosmia

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04408391
Acronym
ANOSIRM
Enrollment
0
Registered
2020-05-29
Start date
2020-05-20
Completion date
2020-07-06
Last updated
2020-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anosmia, Covid-19

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.

Interventions

Resting state, functional, structural and morphometric MRI; diffusion tensor imaging on a 3-Tesla MRI scanner

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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 1/1000. 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

Design outcomes

Primary

MeasureTime frameDescription
Brain regional homogeneity between COVID-19 patients with and without anosmiaDay 0MRI; Voxels

Secondary

MeasureTime frameDescription
Topography of supra- or sub-tentorial lesions between COVID-19 patients with and without anosmiaDay 0MRI; Voxels
Fractional anisotropy between COVID-19 patients with and without anosmiaDay 0MRI; voxels, value between 0-1
Mean diffusivity between COVID-19 patients with and without anosmiaDay 0MRI; mm2/s
Radial diffusivity between COVID-19 patients with and without anosmiaDay 0MRI; mm2/s
Self-assessed olfactory and gustatory testDay 0Four questions measured by 0-100 visual analogue scale: how do you rate the quality of your sense of smell/taste normally/today
Ability to detect odorDay 0Ability to smell 1.5ml air freshner on a 0-100 VAS scale (cut-offs: strang (\>80), moderate (40-80), attenuated (\<40)
Brain regional homogeneity between COVID-19 patients with and without anosmiaMonth 3MRI; Voxels
Presence of thrombotic and hemorrhagic lesionsDay 0MRI: absence/presence
Presence of lesions with hyperintensityDay 0Short Ti Inversion Recovery (STIR); presence/absence
Projection network analysis of all patientsDay 0beta voxels
Blinded independent component analysis of all patientsDay 0beta voxels
default mode network analysis of all patientsDay 0beta voxels
executive control network analysis of all patientsDay 0beta voxels
Ability to taste a pinch of sugarDay 0Patient asked to describe whether a pinch of sugar on their tongue taste sweet or salty

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026