The Role of Oxytocin and Interoception in Functional Neurological Disorder
NCT ID: NCT06084325
Last Updated: 2025-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
110 participants
OBSERVATIONAL
2023-10-05
2025-01-24
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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FND Patients
Group of patients with functional neurological disorders
Respiration resistance sensitivity task (RRST)
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.
Heartbeat Tracking (HBT)
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).
Heartbeat evoked potential (HEP)
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.
Libet task
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.
Healthy control
Age matched group control of healthy participant
Respiration resistance sensitivity task (RRST)
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.
Heartbeat Tracking (HBT)
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).
Heartbeat evoked potential (HEP)
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.
Libet task
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.
Interventions
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Respiration resistance sensitivity task (RRST)
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.
Heartbeat Tracking (HBT)
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).
Heartbeat evoked potential (HEP)
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.
Libet task
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 Intervention Names
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Eligibility Criteria
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Inclusion 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)
Exclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
University of Fribourg
OTHER
Responsible Party
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Locations
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Inselspital
Bern, Canton of Bern, Switzerland
University of Fribourg
Fribourg, Canton of Fribourg, Switzerland
Countries
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Other Identifiers
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2023-00469
Identifier Type: -
Identifier Source: org_study_id
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