Bodily Distress Syndrome Clinical Trial
Official title:
Central Processing of Odour Stimuli in Patients With Multi-systemic Functional Somatic Disorder and Multiple Chemical Sensitivity Compared to Healthy Controls - the Pilot Study
Verified date | October 2022 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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). 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 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 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 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.
Status | Enrolling by invitation |
Enrollment | 40 |
Est. completion date | March 23, 2025 |
Est. primary completion date | March 23, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Female patients and healthy controls 18-60 years old. - Patients with moderate or severe MCS or multi-organ BDS. - Symptoms present >6 months. - Written and verbal informed consent and letter of authority. Exclusion Criteria: 1. Before the beginning of the study; Current sinonasal illness or upper respiratory tract allergy. Serious or unstable medical illness (e.g. Apoplexy, Parkinson's, Alzheimer's disease, ischemic extremity pain, renal failure, liver failure, epilepsy, and Raynaud's phenomenon) that is confirmed by medical history and, if possible, compared to medical records. Current and previous diagnosis of mania, bipolar disorder, psychosis, severe agitation, imminent deliria, current suicide risk, alcohol or drug dependence (ICD-10). Confirmed by psychiatric history and, if possible, compared to psychiatric or medical records. Pregnancy and lactation. MR & MEG scanner incompatibility, assessed by an MR/MEG control questionnaire. 2. After the beginning of the study; MRI diagnosis of incidental pathologic findings; Lesions, Hemorrhage, etc. The onset of acute depression or serve anxiety. Relevant transference to treatment option should be initiated immediately. Suicide risk (treatment will be initiated immediately). Pregnancy and lactation. The patient wishes to leave the study. The patient cannot co-operate during the examination. |
Country | Name | City | State |
---|---|---|---|
Denmark | The Research Clinic for Functional Disorders | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | "Fingerprinting" | The investigators seek to employ whole-brain computational modeling based on MRI-derived functional and structural connectomes. The investigators will use the 3T MR Siemens® scanner that is situated at Aarhus University Hospital. A T1 structural image sequence will be run to obtain an image for later co-registration. After scanning data analyses including pre-processing, first-level analyses, and higher-level analyses will carry out. | Through study completion, an average of 6 months | |
Primary | "Sniffing Stick test" | The standardized psychophysical olfactory test, the "Sniffing Stick" test; will be performed on all three groups of participants before the scanning session. This battery of tests consists of odor threshold (T), discrimination (D), and identification (I) parts. The total score (TDI) was determined by the sum of the three scores (T+D+I).
Habituation test; In order to test the flexible hedonic evaluation of odors in MCS and BDS compare to healthy controls the investigators will carry out habituation tests. The evaluation task asks the participant to rate the odors pleasantness, all individuals responses will be arranged by Likert scale 1-5. |
Through study completion, an average of 6 months. | |
Secondary | Pain thresholds | Pressure pain thresholds by the pressure algometer and cold pressure test with ice water | Through study completion, an average of 3 months. | |
Secondary | Heart Rate Variability | Heart Rate Variability during rest and deep breathing | Through study completion, an average of 6 months. | |
Secondary | Cognitive testing | Participants' cognitive function will also be examined by a series of mental tests. For example, the participant is asked to connect 25 dots on a piece of paper as quickly as possible and in the correct order. Another example is that participants have to repeat a series of numbers from front to back. | Through study completion, an average of 6 months. |
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