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Completed

NCT Number: NCT06084325

The Role of Oxytocin and Interoception in Functional Neurological Disorder

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inselspital, Bern, Canton of Bern, Switzerland

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Respiration resistance sensitivity task (RRST)

Device

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.

Other names: Respiration resistance device

Heartbeat Tracking (HBT)

Behavioral

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).

Other names: ECG

Heartbeat evoked potential (HEP)

Device

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.

Other names: ECG + EEG

Libet task

Device

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.

Other names: Respiration belt + EEG

Primary outcomes

  1. Difference of interoception behavioural scores between FND patients and Healthy controls

    Time frame: 1 day

    Assessment of the difference between interoception tasks scores between these groups. These scores evaluated the interoception processing abilities of patient/control.

  2. Difference in brain electrophysiology during interoception processing between FND patients and Healthy controls

    Time frame: 1 day

    Assessment of the difference Evoked Related potential (ERPs) during interoception taks between these groups.

  3. Association between oxytocin system and interoception and its difference between FND patients and Healthy controls

    Time frame: 1 day

    Study of the correlation between oxytocin system and interoception indices. Oxytocin system was studied with oxytocin concentration (saliva) and genetic markers (blood analysis).

Secondary outcomes

  1. Oxytocin concentration (Saliva sampling)

    Time frame: 1 day

    During the day of the experimental session, 4 samples of saliva at different time are collected. These sample will be used to determine the concentration of oxytocin during the day (30 min post awakening, 30min after lunch, at tasks, upon the arrival for experimental session, after the completion of all tasks).

  2. Epigenetic profile

    Time frame: 1 day

    Blood sample are used for genetic analysis on the oxytocin markers (such as allele-frequency in the oxytonergic receptor gene). Correlation of this with interoceptive scores.

  3. Respiratory Resistance Sensitivity

    Time frame: 1 day

    Difference of accuracy between FND patients and healthy control in the respiratory resistance sensitivity task.

  4. Behavioral measure: heartbeat counting

    Time frame: 1 day

    Difference of accuracy between FND patients and healthy control to count the number of their own heartbeats.

  5. Electrophysiological measure (EEG): Heartbeat evoked potential (HEP) task1

    Time frame: 1 day

    First, study the HEP difference between interoceptive tones (the own heartbeat) with a control condition of focusing on exteroceptive tones (sounds played). Then comparison between FND patients and healthy control.

  6. Electrophysiological measure (EEG): Heartbeat evoked potential (HEP) task2

    Time frame: 1 day

    First, study the difference of mismatch negativity (MMN) evoked potential either if external tone was synchronous or asynchronous with heartbeat. Then comparison between FND patients and healthy control.

  7. Neurophysiological measures: Correlation between agency task and respiration cycle (Libet)

    Time frame: 1 day

    Study of the correlation between a free will key press and the state in respiration cycle. Then comparison of the results between FND patients and healthy control.

  8. Electrophysiological measure (EEG): the readiness potential (Libet)

    Time frame: 1 day

    Analysing the readiness potential related with the motor movement in the implicit compared to the explicit trigger. Then comparison of the results between FND patients and healthy control.

  9. The localization of neuronal activity derived from EEG during interoceptive tasks, and during resting state

    Time frame: 1 day

    Use of the EEG signal during cardiac interception task (HEP),agency task (Libet) and resting to estimate the source generator of brain activities (inverse solution).

  10. Behavioral measure: Correlation between oxytocin and clinical questionaire

    Time frame: 1 day

    Correlating the scores or categories of childhood trauma, attachment style and sexual functioning to oxytocin levels.

Sponsors and collaborators

Lead sponsor

University of Fribourg

Other

Collaborators

  • Insel Gruppe AG, University Hospital Bern

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2023
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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