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临床试验/NCT04968223
NCT04968223已完成不适用

Neural Correlates of Social Touch and Interoceptive Perception As Potential Biomarker for Impaired Social Functioning

University of Oldenburg1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2021年8月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
106
试验地点
1
主要终点
Behavioral responses in a social touch fMRI task

研究概览

简要总结

Recent studies have shown that certain biomarkers of schizophrenia could help to better assess the individual course of the disease and thus, contribute to more personalized treatment options. The aim of the SPIRIT study is to identify potential biomarkers for the prediction of disease-associated outcomes by investigating the neurobiological mechanisms of underlying schizophrenia-related dysfunctions.

详细描述

Alterations in psychosocial functioning are evident from the prodromal phase of schizophrenia and play a crucial role in its chronic course. While recent studies have demonstrated the predictive validity of structural changes in the brain anatomy of patients with schizophrenia, there is a lack of studies assessing the predictive value of disease-associated alterations in the functional brain activity for symptom severity and psychosocial functioning in schizophrenia.

In this longitudinal, observational study, 60 patients with schizophrenia and 40 healthy subjects without family history of psychotic illness will be recruited to investigate differences in behavioural, physiological, and neural correlates of social touch and interoceptive perception between participant groups. Participants' symptom severity and psychosocial functioning level will be examined by a wide range of behavioural, physiological, and neural methods. Potential biomarkers will be identified by estimating the predictive value of initially performed methods on follow-up re-examination of clinical and psychosocial outcomes. Neural readouts include structural and functional magnetic resonance imaging (fMRI) measurements. The fMRI tasks will probe the processing of social touch and interoceptive perception; additionally resting-state connectivity will be assessed. To further investigate pathological distortions of social touch and interoceptive perception, bodily touch allowance maps will be measured and participants will perform a heart-beat discrimination task. Psychometric questionnaires and semi-structured interviews will be used to capture symptom load and level of psychosocial functioning. Long-term effects will be assessed by online questionnaires and semi-structured interviews via phone call 3- and 6 months after initial assessments. The investigators hypothesize that differences in the neural response to social touch as well as in the neural patterns of interoceptive perception could serve as potential biomarkers for psychosocial deficits during the course of the illness. Furthermore, the inclusion of those biomarkers in predictive models could improve the prediction of disease progression and thus, contribute to personalized therapy.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participant is able to provide consent.
  • Diagnosis of schizophrenia or schizoaffective disorder according to DSM-V
  • Control group: No psychiatric or neurological illness.
  • Fluent in German.

排除标准

  • The participant does not fulfill requirements for MRI measurements according to safety guidelines.
  • Acute suicidality.
  • Current substance dependence.
  • A history of head trauma or neurological illness.

结局指标

主要结局

Behavioral responses in a social touch fMRI task

时间窗: One-time baseline assessment

Measured as behavioral ratings during the social touch fMRI task. During the social touch fMRI task, participants rate the comfort of the tactile stimuli on a visual analogue scale.

Changes in clinician-rated symptom severity between baseline and follow-ups

时间窗: Baseline, 3 and 6 months follow- up after initial baseline assessment

Measured by half-structured interviews (e.g. Positive and Negative Syndrome Scale (PANSS); range: 30-210; higher scores indicating more severe symptoms) for disease-related symptoms

Changes in self-reported symptom severity between baseline and follow-ups

时间窗: Baseline, 3 and 6 months follow- up after initial baseline assessment

Measured by self-evaluation questionnaires (e.g. Self-assessment of Negative Symptoms (SNS); range 1-20; higher scores indicating more severe symptoms) for disease-related symptoms

Neural responses in a social touch task

时间窗: One-time baseline assessment

Participants will be measured with functional magnetic resonance imaging (fMRI) while they perceive different types of social and non-social touch

Neural responses in an interoception fMRI task

时间窗: One-time baseline assessment

Participants will be measured with functional magnetic resonance imaging (fMRI) while they perform an interoception task

Behavioral responses in an interoception fMRI task

时间窗: One-time baseline assessment

Measured by performance on the interoception task. During the interoception fMRI task, participants rate how intensely they perceived their heartbeat or their stomach on a visual analogue scale.

Changes in self-reported social-role functioning levels between baseline and follow-ups

时间窗: Baseline, 3 and 6 months follow-up after initial baseline assessment

Measured by the self-evaluation questionnaires for social-role functioning (e.g. Social Network Index (SNI); range 1-12; higher scores indicating higher functioning)

Changes in clinician-rated social-role functioning between baseline and follow-ups

时间窗: Baseline, 3 and 6 months follow- up after initial baseline assessment

Measured by the clinician-rated the social-role functioning scale (range: 1-10; higher scores indicating higher functioning)

次要结局

  • Interoceptive awareness(One-time baseline assessment)
  • Attitude towards social touch(One-time baseline assessment)
  • Bodily maps of social touch(One-time baseline assessment)
  • Interoceptive accuracy(One-time baseline assessment)
  • Blood parameter(One-time baseline assessment)
  • Neural activity at resting state(One-time baseline assessment)
  • Structural connectivity measure(One-time baseline assessment)
  • Urine parameter(One-time baseline assessment)

研究者

发起方
University of Oldenburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dirk Scheele

Deputy Lab Head

University of Oldenburg

研究点 (1)

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