REtinal and VIsual Cortical Response in Early PSYchosis
Not Applicable
Terminated
- Conditions
- Prodromal SchizophreniaPsychotic EpisodeProdromal SymptomsHealthy 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
- 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
Name Time Method N95 wave;a wave;b wave;P100 wave
- Secondary Outcome Measures
Name Time Method 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)