This project will focus on rehabilitation of olfactory dysfunction in patients with chronic rhinosinusitis with polyps given biological treatment based on functional magnetic resonance imaging.
Age 18 years or above
Olfactory dysfunction (i.e., a TDI score < 30.75)
Eligible for treatment with biologics (i.e., meeting the Danish criteria for treatment with biologics (40) which includes fulfillment of the EPOS criteria for CRS.
Either treatment naïve to biologics or had their first injection within a maximum of 48 hours prior to the scan.
Previously recognized loss of sense of smell and taste due to other sinonasal or neurological conditions.
Neurodegenerative disorders known to cause olfactory deficits (Parkinson's, Alzheimer's, Lewy-Body Dementia, Amyotrophic lateral Sclerosis etc.)
Other obvious explanation for the OD (i.e., smell loss occurring in relation to one of the following (including, but not limited to): head trauma, sinus surgery, upper respiratory infection.
Implants or prostheses of magnetic metal
A study population of patients form the out-patient clinic at Copenhagen University Hospital, Rigshospitalet with CRSwNP offered treatment with biologics meeting the criteria for treatment with biologic as stated in the European Position Paper on Rhinosinusitis and Nasal Polyps 2020 (EPOS 2020) as well as the Danish Medicines Council criteria to be considered for inclusion. Furthermore, healthy controls matched by sex and age recruited through advertisement.
Case-control
Prospective
Not listed
Representational Similarity Matrix (RDM)
Change in representational dissimilarity matrices (RDMs) derived from functional magnetic resonance imaging (fMRI) data during an odor categorization task. RDMs will be constructed from multivoxel activation patterns elicited by three odor stimuli within predefined olfactory regions of interest
Threshold-Discrimination-Identification (TDI) score
Changes in olfactory function measured by Sniffin' Sticks Threshold-Discrimination-Identification (TDI) score
Correlation between changes in RDM metrics and changes in TDI score.
Evaluation of the relationship between treatment-related changes in neural olfactory representations and clinical improvements in olfactory performance.
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Rigshospitalet, Denmark
Lead sponsor
Klinik für Psychiatrie und Psychotherapie der Universität Regensburg
Collaborator
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
