Perception and Integration of Sensory Information in the Early Stages of Psychosis

Обзор

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.

Вмешательства

• Поведенческое behavioral tasks
  All participants will undergo behavioral assessments of visual and auditory processing, including contrast sensitivity, facial emotion recognition, visual inference using Necker cubes, tone-matching, and auditory emotion recognition.
• Устройство Electroretinography
  Participants will additionally undergo electrophysiological recordings of retinal function (a-wave, b-wave, phNR, oscillatory potentials) using flash stimulation.
• Диагностический тест Comprehensive Assessment of At Risk Mental States (CAARMS)
  All participants will be assessed using the CAARMS in order to evaluate their symptoms and classify them into either the CHR or FEP group
• Поведенческое Neuropsychological tests
  TAP attention and working memory test, fNART, VOSP, Verbal fluency test.

Первичные конечные точки

• Contrast sensitivity task [Срок оценки: Day 1 for healthy controls, Day 1-30 for patients]
• Facial emotion recognition task [Срок оценки: Day 1 for healthy controls, Day 1-30 for patients]
• Visual inference task [Срок оценки: Day 1 for healthy controls, Day 1-30 for patients]
• Tone matching task [Срок оценки: Day 1 for healthy controls, Day 1-30 for patients]
• Auditory emotion recognition task [Срок оценки: Day 1 for healthy controls, Day 1-30 for patients]
• ERG measure [Срок оценки: Day 1 for healthy controls, Day 1-30 for patients]
• CAARMS assessment [Срок оценки: Day 1]

Вторичные конечные точки (6)

• CAARMS assessment [Срок оценки: 6 months follow up]
• TAP Working Memory test [Срок оценки: Day 1]
• fNART [Срок оценки: Day 1]
• Tap attention test [Срок оценки: Day 1]
• Visual Object and Space Perception Battery (VOSP) [Срок оценки: Day 1]
• Verbal fluency test [Срок оценки: Day 1]

Критерии участия

Критерии включения

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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 4 центра

• Centre Hospitalier Le Vinatier — Bron
• Centre Psychothérapique de Nancy — Laxou
• Centre Hospitalier Alpes-Isère — Saint-Égrève
• Centre Hospitalier Universitaire de Saint Etienne — Saint-Priest-en-Jarez

Идентификаторы

NCT: NCT07446569 · 2024-A02456-41 · RIPH 2024-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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