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临床试验/NCT06084325
NCT06084325已完成不适用

The Role of Oxytocin and Interoception in Functional Neurological Disorder

University of Fribourg2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
2
主要终点
Difference of interoception behavioural scores between FND patients and Healthy controls

研究概览

简要总结

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).

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Difference of interoception behavioural scores between FND patients and Healthy controls

时间窗: 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

时间窗: 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

时间窗: 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).

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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