跳至主要内容
临床试验/NCT05595434
NCT05595434招募中不适用

Study of Reality-monitoring Process and Influence of Stress Using an Electrophysiological Approach

Hôpital le Vinatier2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
2
主要终点
Reality-monitoring performances

研究概览

简要总结

Reality-monitoring is a crucial cognitive process in daily life to remember the source of an information. Deficits of reality-monitoring have been shown into the continuum of schizophrenia, suggesting a preexisting alteration in population at-risk for psychosis that will be exacerbated during psychotic transition. It is admitted that stress plays a crucial role in the psychotic transition and can alter cognitive performances. However, less is known about the effects of stress on reality-monitoring, even though this process appears to be central in psychotic disorders.

The aim of this project is to investigate the effect of stress on reality-monitoring, both on behavioral and neurophysiological aspects

详细描述

Forty healthy subjects will be included in the study. Participants will be subject to a standardized stress protocol, half of them receiving an active stress and the other half receiving a placebo. All participants will also complete a reality-monitoring task, electrophysiological (EEG) recordings as well as socio-demographic and psychometric evaluations

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Participants will not be informed about the nature (active or placebo) of the stress test they will perform.

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Right-handed Men and Women aged between 18 and 30
  • Having given their written informed consent
  • For women: oral contraceptive use
  • French speakers and readers

排除标准

  • Do not consent to be included in the study
  • Night workers
  • Having visual or hearing impairments that could prevent the successful completion of tasks involving reading or listening to sounds
  • Taking drug treatment (except oral contraceptive)
  • Having a somatic pathology in particular neurological, endocrinal or blood circulation diseases (e.g., Raynaud's disease)
  • Having personal or first-degree relatives' history of diagnosed psychiatric disorders (according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - DSM5)
  • Having psychotic prodomes measured by a score above 6 in the "prodomal questionnaire' - PQ-16 (Ising et al., 2012)
  • Having developed musical abilities (that is, regularly practicing a musical instrument)
  • Being pregnant or nursing

结局指标

主要结局

Reality-monitoring performances

时间窗: within 1 hour after the stress procedure

scores obtained at the reality-monitoring task (accuracy, range 0-100%)

次要结局

  • Subjective stress(1 time before and 1 time 1 hour after the stress procedure)
  • electroencephalogram (EEG) activity(1time within 1 hour after the stress procedure)
  • Working memory(1 time within 1 hour after the stress procedure)
  • Heart rate(throughout and within 1 hour after the stress procedure)
  • Blood pressure(throughout and within 1 hour after the stress procedure)
  • Salivary cortisol(throughout and within 1 hour after the stress procedure)
  • Psychometric characteristics that may influence stress response (1)(Basline, before the stress procedure)
  • expression rate of genes involved in the regulation of the glucocorticoid receptor signaling pathway(1 time before and 1 time 1 hour after the stress procedure)
  • Basic auditory performances(1 time within 1 hour after the stress procedure)
  • Psychometric characteristics that may influence stress response (3)(Basline, before the stress procedure)
  • Psychometric characteristics that may influence stress response (2)(Basline, before the stress procedure)
  • Psychometric characteristics that may influence stress response (4)(Basline, before the stress procedure)
  • Psychometric characteristics that may influence stress response (5)(Basline, before the stress procedure)

研究者

发起方
Hôpital le Vinatier
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验