The Role of Oxytocin and Interoception in Functional Neurological Disorder
1 other identifier
observational
110
1 country
2
Brief Summary
The main goal of this project is to better understand the role of oxytocin and Interoception in FND. More specifically oxytocin's association with precision weighing, prediction errors and priors in the interoceptive domains will be investigated. To this end, several methods will be employed: analysis of interoceptive accuracy and sensibility (interoceptive tasks and questionnaires), biomarkers of oxytocin (peripheral, endogenous oxytocin), genetic oxytocin markers (such as allele-frequency in the oxytonergic receptor gene), epigenetics (methylation rates of genes related to oxytocin), neuroactivity (EEG).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2023
CompletedStudy Start
First participant enrolled
October 5, 2023
CompletedFirst Posted
Study publicly available on registry
October 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 24, 2025
CompletedMarch 27, 2025
March 1, 2025
1.3 years
September 20, 2023
March 24, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Difference of interoception behavioural scores between FND patients and Healthy controls
Assessment of the difference between interoception tasks scores between these groups. These scores evaluated the interoception processing abilities of patient/control.
1 day
Difference in brain electrophysiology during interoception processing between FND patients and Healthy controls
Assessment of the difference Evoked Related potential (ERPs) during interoception taks between these groups.
1 day
Association between oxytocin system and interoception and its difference between FND patients and Healthy controls
Study of the correlation between oxytocin system and interoception indices. Oxytocin system was studied with oxytocin concentration (saliva) and genetic markers (blood analysis).
1 day
Secondary Outcomes (10)
Oxytocin concentration (Saliva sampling)
1 day
Epigenetic profile
1 day
Respiratory Resistance Sensitivity
1 day
Behavioral measure: heartbeat counting
1 day
Electrophysiological measure (EEG): Heartbeat evoked potential (HEP) task1
1 day
- +5 more secondary outcomes
Study Arms (2)
FND Patients
Group of patients with functional neurological disorders
Healthy control
Age matched group control of healthy participant
Interventions
The RRST measures interoception on the domain of the breath and thus allows its (non-invasive) manipulation. The RRST apparatus includes a step motor that moves a wedge piece back and forth to change the obstruction level in the breathing circuit. This fully automated apparatus will change the breathing obstruction level via a computer-controlled algorithm. The patient breath by the month though this device.
The HBT measures interoception on the domain of the cardiovascular system, by assessing how accurate participants perceive their own heartbeat. After each time window participants will be asked how many heartbeats they counted, which will be compared to the actual heartbeat measured via electrocardiography (ECG).
The HEP is computed by averaging EEG signals time-locked to specific peaks of simultaneously measured ECG signals. Therefore both an ECG and an EEG will be set up for the participants. The task during the HEP is to simply focus on interoceptive tones (the own heartbeat) with a control condition of focusing on exteroceptive tones (sounds played). A further condition of HEP measurement is the cardio-audio synchronization. Hereby, participants will be instructed to passively listen to sounds presented to them via in-ear phones while further fixating the cross.
Additionally we also link the interoceptive domain of the breath to a well-known and established agency task measuring conscious intention. Participants will do two versions of the Libet taks while simultaneously recording their EEG and breathing signals with a respiratory belt.
Eligibility Criteria
FND patients Participants who are patients will be recruited from the in- and out-patients pool of the Clinic for Neurology of the Hospital of Fribourg and the Inselspital. At both, the treating physician will identify suitable patients (i.e. patients who fulfil the clinical requirement for FND as described in the DSM-5). The treating physician will ask these patients whether they would like to be approached by the Investigator (or his/her designee) concerning a scientific study. In case of affirmative response, the Investigator will approach the patients, inform them about the study. Healthy control Healthy controls will be recruited among students, collaborators, and visitors of the University of Fribourg and Bern, the Hospital of Fribourg and the Inselspital. They will be recruited by flyer, by word-of-mouth and through advertisements in public media.
You may qualify if:
- A diagnosis of FND according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) diagnostic criteria
- Capable of judgement
- Willing to participate in the study (by signing the informed consent form)
- Capable of judgement
- Willing to participate in the study (by signing the informed consent form)
You may not qualify if:
- Presence of comorbid disorders such as psychosis or major depression with suicidal risk
- History of actual or suspected epilepsy
- Past surgery in the brain
- Cardio-vascular disease
- Implanted Investigational Medicinal Products (e.g. cochlear implants, neurostimulators, cardiac pacemakers)
- History of alcohol or drug abuse
- For female participants: breastfeeding, pregnancy (a standard urine pregnancy test will be provided)
- \<6h prior application prostaglandin
- Long QT-syndrome
- Inability to follow the procedures of the study, e.g. due to language problems
- History of actual or suspected epilepsy
- Past surgery in the brain
- Cardio-vascular disease
- Implanted Investigational Medicinal Products (e.g. cochlear implants, neurostimulators, cardiac pacemakers)
- History of alcohol or drug abuse
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Fribourglead
- Insel Gruppe AG, University Hospital Berncollaborator
Study Sites (2)
Inselspital
Bern, Canton of Bern, 3010, Switzerland
University of Fribourg
Fribourg, Canton of Fribourg, 1700, Switzerland
Biospecimen
7.5 ml of blood (2 x 3.4ml EDTA) are taken from the test persons. The DNA is then extracted from the blood using the QIAamp DNA Blood Mini Kit (QIAGEN, Germany).
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2023
First Posted
October 16, 2023
Study Start
October 5, 2023
Primary Completion
January 24, 2025
Study Completion
January 24, 2025
Last Updated
March 27, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share