Central Processing of Odour Stimuli in Patients With Functional Somatic Disorder, MCS or Post Covid Compared to Healthy Controls

Summary

Background:

Functional somatic disorders (FSD) are frequent in all medical settings and characterized by persistent physical symptoms that cannot be explained by other somatic or psychiatric conditions. In recent decades, a number of different types of functional somatic disorders have been defined, but so far there is no clear explanation for the pathophysiology.

The high prevalence of olfactory problems in some patients with FSD suggests that olfactory symptoms are a potential diagnostic biomarker, especially in patients with multiple chemical sensitivity (MCS) and/ or post-covid.

The olfactory system is a unique sense with direct pathways to the limbic system, which is associated with emotion and mood. The focus on the olfactory system has revealed a significant association of this sense with numerous diseases.

Hypotheses:

* Patients with MCS and FSD have normal olfactory tests (normosmic subjects according to TDI score using "sniffing test") but differ in habituation test compared to healthy controls.
* MCS, post-covid and FSD patients have different odour perception processing in the brain as a "fingerprint" of functional somatic disorder compared to healthy controls.

Research plan:

The aim of this parts of the study is to identify specific MRI and paraclinical measures for MCS, post covid and BDS. In the first phase, 5 patients with MCS and 5 healthy controls will have a full clinical test of the olfactory system at the Flavour Institute, AU. In addition, they will be scanned (for "fingerprinting") where the investigators expect to find changes in olfactory connectivity similar to those seen in depression. This phase of the study will lead to a conclusion on the exact MR parameters to be used in the main study. In the second phase of the study, 10 patients with MCS, 10 with post-covid, 10 with FSD, and 10 healthy controls will be evaluated using a test battery of questionnaires and paraclinical tests.

Perspectives:

Previous imaging studies have focused on pain stimulation paradigms, rest-state fMRI, and DTI, but the olfactory system may be the "missing link" in identifiying a quantitative candidate in terms of whole-brain computational modeling and could potentially be used as a "fingerprint" in diagnosis and treatment monitoring.

Conditions

• Functional Disorder
• Bodily Distress Syndrome
• Multiple Chemical Sensitivity
• Post COVID-19

Interventions

DIAGNOSTIC_TEST

MRI and paraclinical tests

The patients and controls will be evaluated using MRI and furthermore a large test battery of questionnaires and paraclinical tests. Including the following test: MCS checklist, BDS-Checklist, Symptom Checklist-92 (SCL-92), Whiteley-8, SF-36, Major Depression Inventory (MDI), GAD-10 anxiety scale, and related questionnaire, behavioral olfactory test (TDI), habituation test, pain measurement thresholds tests, Heart Rate Variability and cognitive testing.

Sponsors & Collaborators

• University of Aarhus

  lead OTHER

Principal Investigators

• Lise Gormsen, PhD · Functional Disorders

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-11-02

Primary Completion

2026-08-31

Completion

2026-08-31

Countries

• Denmark

Study Locations