MedPath

REtinal and VIsual Cortical Response in Early PSYchosis

Not Applicable
Terminated
Conditions
Prodromal Schizophrenia
Psychotic Episode
Prodromal Symptoms
Healthy Controls
Registration Number
NCT05167396
Lead Sponsor
Centre Psychothérapique de Nancy
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Terminated
Sex
All
Target Recruitment
34
Inclusion Criteria
  1. Inclusion Criteria:<br><br> 1. All groups<br><br> Age and gender matching<br><br> Age between 18 and 40<br><br> Enrolled in a social security plan<br><br> Normal or corrected-to-normal visual acuity verified by Monoyer test<br><br> In women of childbearing age: negative urine pregnancy test at the inclusion<br> visit<br><br> Person who has received and understood prior information about the study<br><br> Person who has given free and informed written consent prior to any<br> participation in the study<br><br> 2. Healthy control group (HC; n=30)<br><br> Met all groups criteria<br><br> No current disorders as assessed by the MINI global assessment<br><br> No lifetime (hypo)manic episodes or psychotic disorders and current<br><br> No current or past disorders by CAARMS assessment<br><br> No current disorders according to ICD-10 criteria<br><br> No positive family history (parents/first degree) for affective affective,<br> non-affective psychoses or major affective disorders<br><br> No regular use (more than 3 psychotropic medications: benzodiazepines,<br> hypnotics,antidepressants, antipsychotics or mood regulators or<br> psychostimulants) during the past last 12 months<br><br> 3. High clinical risk group for psychosis (CHRP; n=30)<br><br> Met all groups criteria, Assessment at CAARMS:<br><br> - Attenuated positive symptoms (APS)<br><br> - OR Brief Intermittent Psychotic Symptoms (BIPS)<br><br> - OR Attenuated psychosis of sub-laminar frequency<br><br> - OR sub-laminar attenuated psychosis<br><br> Antipsychotic treatment with a cumulative dose of equivalent chlorpromazine<br> <2500mg lifetime (1)<br><br> 4. First Episode Psychosis (FEP; n=30)<br><br> All-group criteria met CAARMS assessment: Psychosis/antipsychotic treatment<br> threshold treatment threshold achieved at CAARMS<br><br> Antipsychotic treatment with a cumulative dose of equivalent chlorpromazine <2500mg<br> lifetime (1)<br><br> 2. Exclusion Criteria (all groups):<br><br>Impairment of the subject that makes it difficult or impossible to participate in the or<br>comprehension of the information provided to him/her<br><br>Dyslexia<br><br>Substance use disorder according to CIM-10<br><br>Neurological history including progressive neurological pathology<br><br>Progressive retinal disease<br><br>Chronic glaucoma<br><br>Ophthalmologic pathology affecting visual acuity<br><br>Current ocular infection<br><br>Major under guardianship, curatorship or safeguard of justice<br><br>Pregnant or breastfeeding women<br><br>Persons in a life-threatening emergency situation<br><br>Result of the preliminary medical examination incompatible with the research<br><br>Patient presenting a suicidal risk.<br><br>Criteria incompatible with the use of the Retinaute:<br><br> - Allergy to silver<br><br> - Known or suspected allergy to any of the following components:<br><br>polyamide, polyester, elastane, latex, rubber, silicone, or any synthetic material as<br>well as to cotton in case the device is used without the device is used without a<br>protective head covering<br><br> - Sensory disorders making the patient insensitive to pain on the skin.<br><br> - Behavioral problems making the patient extremely agitation or aggression.<br><br> - Mental disorders incompatible with the use of the device.<br><br> - Seizure disorder.<br><br> - Open wound in an area covered or wrapped by the device.<br><br> - User at high risk of contagion.<br><br> - Wearing an implantable medical device (e.g. pacemaker)<br><br> - Pregnant women, women in labor or nursing mothers.<br><br> - Allergy or skin sensitivity to one of the components of the cream Elefix or<br> equivalent on the market: coconut oil, egg oil, propylene glycol egg oil, propylene<br> glycol, glycerin, lanolin...<br><br> - Allergy or skin sensitivity to one of the components of the cream NuPrep or market<br> equivalent<br><br>Participation in another interventional study (exclusion period included)
Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
N95 wave;a wave;b wave;P100 wave
Secondary Outcome Measures
NameTimeMethod
Visual Object and Space Perception (VOSP);Verbal Fluency;Working Memory;Betarythm (EEG oscillatory responses);Contingent Negative Variation (CNV);CPT-AX (Continuous Performance Task version AX);fNART (French adaptation of National Adult Reading Test);TAP (Test of Attentional Performance)
© Copyright 2025. All Rights Reserved by MedPath