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Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients

Longitudinal and Comparative Study of Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04526054
Enrollment
13
Registered
2020-08-25
Start date
2020-09-03
Completion date
2021-09-03
Last updated
2022-08-03

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

Conditions

COVID-19, Olfaction Disorders

Keywords

anosmia, smell disorder, COVID-19, MRI

Brief summary

Olfactory and gustatory disorders are prevalent symptoms in European COVID-19 patients. This study aimed to detect these disturbances among positive COVID-19 patients (symptom not initially highlighted by the patient and not sought by caregivers) in order to allow early management of olfactory and gustatory dysfunction.

Detailed description

Several medical teams have recently shown that disturbances of smell and taste are common and can be a precursor and even an isolated sign of COVID-19 involvement. Preliminary results suggest the presence of clinical MRI abnormalities, particularly in the olfactory bulbs in anosmic patients with COVID-19. Anosmia and taste disturbance are early warning signs that could be important in improving the detection and diagnosis of COVID-19, and also in monitoring disease. In addition, disturbances in smell and taste could be an aid in establishing the prognosis of the clinical course of the viral disease. The question of olfactory recovery is also fundamental. To date, we do not know the possibilities of recovery from COVID-19 post viral anosmia. ENT exams, olfactometry and MRI are proposed to study these phenomena.

Interventions

DIAGNOSTIC_TESTENT exam

ENT examination of the nasal cavity: nasofibroscopy and anterior rhinoscopy.

DIAGNOSTIC_TESTOlfactometry

Olfactometry test using odorous pens (Sniffin's stick test).

DIAGNOSTIC_TESTBrain MRI

Brain MRI focused on the olfactory bulbs (3 teslas).

Sponsors

Hôpital Raymond Poincaré
CollaboratorOTHER
Hopital Foch
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient aged 18 or over * Patient with or without a sense of smell diagnosed with a positive COVID-19 PCR test by nasopharyngeal swab in one of the investigation centers * Patient who has already undergone cerebral MRI and olfactometry, as part of their routine care, within 3 days of being diagnosed with COVID-19+ or who agrees to undergo cerebral MRI and olfactometry within 3 days of being diagnosed with COVID-19+. * Patient who signed a consent form * Patient being affiliated to a Health Insurance plan

Exclusion criteria

* History of chronic rhino-sinusitis with or without polyp (s) * History of major craniofacial trauma that led to loss of smell * History of chronic sense of smell * Diagnosis of Parkinson's disease or Alzheimer's disease * Refusal to perform the 3 MRIs * Refusal to participate in the study * Pregnant, parturient or lactating woman * Patient with contraindications to performing MRI * Patient not speaking or understanding French * Patient deprived of liberty or under guardianship

Design outcomes

Primary

MeasureTime frameDescription
To compare the qualitative and quantitative morphological abnormalities of the olfactory bulb detected by MRI on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.initial examinationIntensity ratio calculated between average signals of the olfactory bulb and the frontal white matter on a 3-Tesla MRI scanner.
To compare the result of the olfactometry (Sniffin' test) on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.initial examinationSniffin' test score (T threshold score, D discrimination score, I identification score).

Secondary

MeasureTime frameDescription
Longitudinal evaluation of qualitative and quantitative abnormalities of olfactory bulbs on MRI in in COVID-19 anosmic patient at initial examination, between 6 weeks and 2 months and between 6 and 9 months.initial examination, 6 week to 2 months, 6 to 9 monthsIntensity ratio calculated between average signals of the olfactory bulb and the frontal white matter on a 3-Tesla MRI scanner at initial examination, between 6 weeks and 2 months and between 6 and 9 months.
To compare the result of the olfactometry (Sniffin' test) on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.initial examination, 6 week to 2 months, 6 to 9 monthsSniffin' test score (T threshold score, D discrimination score, I identification score).

Countries

France

Outcome results

None listed

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