Perception and Integration of Sensory Information in the Early Stages of Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 294
- 试验地点
- 4
- 主要终点
- Visual inference task
研究概览
简要总结
The goal of this observational study is to investigate the early sensory system in clinical high risk (CHR), first episode psychosis (FEP) individuals and heathly controls. The main questions it aims to answer are:
- Can anomalies in visual and auditory sensory processing serve as early markers of psychosis risk?
- How are these sensory anomalies related to clinical symptom severity and emotional recognition deficits?
Researchers will compare CHR and PEP participants to healthy controls to see if sensory processing differences can help identify individuals at higher risk of developing psychosis.
Participants will:
- Complete behavioral tasks evaluating visual processing (contrast sensitivity, contour integration, facial emotion recognition, visual inference using Necker cubes) and auditory processing (tone-matching, auditory emotion recognition). A temporal perception component will also be assessed within the auditory and emotion recognition tasks, rather than as a separate task.
- Undergo electrophysiological assessments of retinal function using flash stimulation to record retinal potentials (a-wave, b-wave, phNR, oscillatory potentials).
- Provide demographic, clinical, and neuropsychological data during study visits.
- For CHR participants, attend follow-up visits up to 6 months post initial assessments to evaluate psychotic symptom progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All groups:
- •Age between 18 and 30 years
- •Normal or corrected-to-normal visual acuity
- •Affiliated with or dependent on a social security health insurance plan
- •Provided informed consent and co-signed the study consent form with the investigator
- •Proficient in French
- •Control group (TEM) specific criteria:
- •No current psychiatric disorder (DSM-IV Axis I), except anxiety disorders
- •No lifetime history of (hypo)manic episodes or psychotic disorders
- •No first-degree family history of schizophrenia spectrum disorders
- •No regular use (more than one month continuously) in the past 6 months of the following medications: benzodiazepines, hypnotics, antidepressants, antipsychotics, mood stabilizers, or psychostimulants
- •Clinical High-Risk (CHR) group specific criteria:
- •Meet CHR criteria according to CAARMS: Attenuated positive symptoms (APS) below clinical threshold in intensity or frequency OR Brief Limited Intermittent Psychotic Symptoms (SPLI) OR Genetic Risk
- •First-Episode Psychosis (PEP) group specific criteria:
- •Meet PEP criteria according to CAARMS (psychosis threshold reached)
排除标准
- •Pregnant, postpartum, or breastfeeding women
- •Individuals deprived of liberty by judicial or administrative decision
- •Individuals in a life-threatening emergency
- •Adults under legal protection measures
- •Adults unable to provide consent and not under legal protection
- •Impairment that makes participation in the study or understanding of information difficult or impossible
- •Alcohol dependence (AUDIT score ≥12 for men, ≥11 for women)
- •Current substance use disorder (DAST score >6)
- •Cannabis use disorder (CUDIT-R score ≥13)
- •History of neurological disorders, including progressive neurological disease
- •Progressive retinal disease
- •Chronic glaucoma
- •Ophthalmologic conditions affecting visual acuity
- •Current eye infection
- •Hearing disorders affecting auditory acuity
- •Criteria incompatible with the electroretinographic device:
- •Presence of photosensitive epilepsy
- •Allergy to components of the electrode gel
- •Behavioral problems causing extreme agitation or aggression
- •Eye or surrounding tissue lesions that may come into contact with the device
研究组 & 干预措施
observational behavioral and electrophysiological assessments
干预措施: behavioral tasks (Behavioral)
observational behavioral and electrophysiological assessments
干预措施: Electroretinography (Device)
observational behavioral and electrophysiological assessments
干预措施: Comprehensive Assessment of At Risk Mental States (CAARMS) (Diagnostic Test)
observational behavioral and electrophysiological assessments
干预措施: Neuropsychological tests (Behavioral)
结局指标
主要结局
Visual inference task
时间窗: Day 1 for healthy controls, Day 1-30 for patients
Computerized visual inference task
Tone matching task
时间窗: Day 1 for healthy controls, Day 1-30 for patients
Computerized tone matching task
Facial emotion recognition task
时间窗: Day 1 for healthy controls, Day 1-30 for patients
computerized emotion recognition task
Auditory emotion recognition task
时间窗: Day 1 for healthy controls, Day 1-30 for patients
Computerized emotion recognition task
Contrast sensitivity task
时间窗: Day 1 for healthy controls, Day 1-30 for patients
computerized contrast detection task
ERG measure
时间窗: Day 1 for healthy controls, Day 1-30 for patients
amplitude and latency of the b-wave, a-wave, PhNR and oscillatory potentials
CAARMS assessment
时间窗: Day 1
次要结局
- fNART(Day 1)
- Verbal fluency test(Day 1)
- CAARMS assessment(6 months follow up)
- TAP Working Memory test(Day 1)
- Tap attention test(Day 1)
- Visual Object and Space Perception Battery (VOSP)(Day 1)