Status:

COMPLETED

The Role of Oxytocin and Interoception in Functional Neurological Disorder

Lead Sponsor:

University of Fribourg

Collaborating Sponsors:

Insel Gruppe AG, University Hospital Bern

Conditions:

Functional Neurological Disorder

Eligibility:

All Genders

18+ years

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 t...

Detailed 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 neurologica...

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

Exclusion

    Key Trial Info

    Start Date :

    October 5 2023

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    January 24 2025

    Estimated Enrollment :

    110 Patients enrolled

    Trial Details

    Trial ID

    NCT06084325

    Start Date

    October 5 2023

    End Date

    January 24 2025

    Last Update

    March 27 2025

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Inselspital

    Bern, Canton of Bern, Switzerland, 3010

    2

    University of Fribourg

    Fribourg, Canton of Fribourg, Switzerland, 1700