The Role of Oxytocin and Interoception in Functional Neurological Disorder

Last updated: March 24, 2025
Sponsor: University of Fribourg
Overall Status: Completed

Phase

N/A

Condition

Anxiety Disorders

Hypochondriasis

Neurologic Disorders

Treatment

Heartbeat evoked potential (HEP)

Libet task

Heartbeat Tracking (HBT)

Clinical Study ID

NCT06084325
2023-00469
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria for Patients:

  • 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)

Inclusion Criteria for Healthy controls:

  • Capable of judgement

  • Willing to participate in the study (by signing the informed consent form)

Exclusion Criteria for Patients:

  • 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

Exclusion Criteria for Healthy controls:

  • 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

Study Design

Total Participants: 110
Treatment Group(s): 4
Primary Treatment: Heartbeat evoked potential (HEP)
Phase:
Study Start date:
October 05, 2023
Estimated Completion Date:
January 24, 2025

Study Description

The primary objective is to explore interoceptive processing during a behavioural (interoceptive) tasks and its association to the oxytocin (OT) system in patients affected by a functional neurological disorder (FND), in comparison to healthy controls (HC).

Concerning interoception, as primary outcome, it is hypothesized that:

A) FND patients are less interoceptive (judged by objectively measured accuracy) compared to HC in the interoceptive tasks.

Concerning OT, as primary outcome, it is hypothesized that:

B) The OT level is correlated with interoception tasks; specifically the adaption of precision weighting

The secondary objectives are to:

  • Explore the validity and reliability of different interoceptive tasks (e.g. respiratory, cardiovascular, emotional tasks)

  • Explore neuronal regions associated with interoceptive processing and interoceptive accuracy in FND compared to HC

  • Investigate whether FND patients have a higher interoception trait-prediction error (discrepancy between subjective and objective interoception scores) and whether this correlates with their symptom severity

  • Explore the association of the breathing cycle and the voluntary initiation of mental or motor actions, and its readiness potential

  • Explore peripheral biomarkers (e.g. salivary OT) in FND patients, compared to HC

  • Explore the differences in (epi)genetic profile associated with the OT-system in FND compared to HC

  • Investigate the association of the OT-system and traumatic childhood experience, attachment styles and sexual functioning in patients of FND compared to HC

Connect with a study center

  • Inselspital

    Bern, 3010
    Switzerland

    Site Not Available

  • University of Fribourg

    Fribourg, 1700
    Switzerland

    Site Not Available

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