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临床试验/NCT06375902
NCT06375902Enrolling By Invitation不适用

The Fragility of Metaphors (FraMe): Learning, Loosing, and How to Train Them

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年7月12日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
64
试验地点
1
主要终点
Tracking down the difficulties in metaphor comprehension via task during electrophysiological recording

研究概览

简要总结

Tracking down the difficulties in metaphor comprehension experienced by individuals with schizophrenia across different metaphor types and exploring the neurological correlates via EEG recording technique

详细描述

The investigators will address the following objectives:

  • Primary Objective: Tracking down the difficulties in metaphor comprehension experienced by individuals with schizophrenia across different metaphor types and exploring the neurological correlates via EEG recording technique
  • Secondary Objectives: 1) Evaluate the interactions between performances in metaphor comprehension and individual differences in psychopathology, cognition, ToM and functioning; 2) Test if the altered neurophysiological patterns associated to the fragility of metaphor comprehension in schizophrenia can be restored through a rehabilitative training

The investigators will enroll 32 schizophrenic patients and 32 healthy subjects as control sample.

Participants will undergo an initial visit with a specialist psychiatrist who will verify that their conditions meet the criteria required by the study. Then, subjects will be tested for metaphor comprehension, as well as for the other variables included in the study, and the electrical brain activity will be registered through a 128 channel EEG.

In the check-up visits (i.e., after the training) the following data will be collected:

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

  • For patients:
  • Age between 18 and 65 years
  • Diagnosis of Schizophrenia according to DSM V criteria
  • Ability to provide informed consent
  • For healthy controls:
  • Age between 18 and 65 years
  • Ability to provide informed consent
  • Absence of psychiatric pathologies
  • Ability to speak Italian

排除标准

  • For patients:
  • Intellectual disability
  • Neurological disorder
  • For healthy controls:
  • Presence of psychiatric pathologies
  • Difficulties in speaking Italian

结局指标

主要结局

Tracking down the difficulties in metaphor comprehension via task during electrophysiological recording

时间窗: through study completion, an average of 2 years

Exploring the difference in the neurological correlates (via electrophysiological recording technique) between patients and controls. Electrophysiological indexes that will be evaluated are event-related potential after the stimulus presentation.

Tracking down the difficulties in metaphor comprehension via a behavioural task

时间窗: through study completion, an average of 2 years

Tracking down the difficulties in metaphor comprehension experienced by individuals with schizophrenia compared to healthy controls across different metaphor types through the Physical and mental metaphor task (PMM) (range values 0-28, higher scores mean a better outcome).

次要结局

  • Evaluation of functioning(through study completion, an average of 2 years)
  • Evaluation of Theory of Mind(through study completion, an average of 2 years)
  • Evaluation of psychopathology(through study completion, an average of 2 years)
  • Evaluation of cognition(through study completion, an average of 2 years)
  • Evaluate the efficacy of a rehabilitative training in restoring metaphor comprehension ability(through study completion, an average of 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marta Bosia

Prof.ssa

IRCCS San Raffaele

研究点 (1)

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