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Clinical Trials/NCT06084325
NCT06084325
Completed
Not Applicable

The Role of Oxytocin and Interoception in Functional Neurological Disorder

University of Fribourg2 sites in 1 country110 target enrollmentOctober 5, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Functional Neurological Disorder
Sponsor
University of Fribourg
Enrollment
110
Locations
2
Primary Endpoint
Difference of interoception behavioural scores between FND patients and Healthy controls
Status
Completed
Last Updated
last year

Overview

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).

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 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

Registry
clinicaltrials.gov
Start Date
October 5, 2023
End Date
January 24, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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.

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

  • Electrophysiological measure (EEG): Heartbeat evoked potential (HEP) task2(1 day)
  • Oxytocin concentration (Saliva sampling)(1 day)
  • Epigenetic profile(1 day)
  • Respiratory Resistance Sensitivity(1 day)
  • Neurophysiological measures: Correlation between agency task and respiration cycle (Libet)(1 day)
  • Behavioral measure: Correlation between oxytocin and clinical questionaire(1 day)
  • Behavioral measure: heartbeat counting(1 day)
  • Electrophysiological measure (EEG): the readiness potential (Libet)(1 day)
  • The localization of neuronal activity derived from EEG during interoceptive tasks, and during resting state(1 day)
  • Electrophysiological measure (EEG): Heartbeat evoked potential (HEP) task1(1 day)

Study Sites (2)

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