Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:26 PM
Study NCT ID:
NCT07446569
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perception and Integration of Sensory Information in the Early Stages of Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D012569', 'term': 'Schizotypal Personality Disorder'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010554', 'term': 'Personality Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004596', 'term': 'Electroretinography'}, {'id': 'D009483', 'term': 'Neuropsychological Tests'}], 'ancestors': [{'id': 'D003941', 'term': 'Diagnostic Techniques, Ophthalmological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 294}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contrast sensitivity task', 'timeFrame': 'Day 1 for healthy controls, Day 1-30 for patients', 'description': 'computerized contrast detection task'}, {'measure': 'Facial emotion recognition task', 'timeFrame': 'Day 1 for healthy controls, Day 1-30 for patients', 'description': 'computerized emotion recognition task'}, {'measure': 'Visual inference task', 'timeFrame': 'Day 1 for healthy controls, Day 1-30 for patients', 'description': 'Computerized visual inference task'}, {'measure': 'Tone matching task', 'timeFrame': 'Day 1 for healthy controls, Day 1-30 for patients', 'description': 'Computerized tone matching task'}, {'measure': 'Auditory emotion recognition task', 'timeFrame': 'Day 1 for healthy controls, Day 1-30 for patients', 'description': 'Computerized emotion recognition task'}, {'measure': 'ERG measure', 'timeFrame': 'Day 1 for healthy controls, Day 1-30 for patients', 'description': 'amplitude and latency of the b-wave, a-wave, PhNR and oscillatory potentials'}, {'measure': 'CAARMS assessment', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'CAARMS assessment', 'timeFrame': '6 months follow up', 'description': 'Follow-up symptomatic assessment to evaluate the predictive power of sensory treatment (computerized tasks, ERG) for the risk of psychotic transition.'}, {'measure': 'TAP Working Memory test', 'timeFrame': 'Day 1'}, {'measure': 'fNART', 'timeFrame': 'Day 1'}, {'measure': 'Tap attention test', 'timeFrame': 'Day 1'}, {'measure': 'Visual Object and Space Perception Battery (VOSP)', 'timeFrame': 'Day 1'}, {'measure': 'Verbal fluency test', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Early Psychosis', 'Schizophrenia Prodromal']}, 'descriptionModule': {'briefSummary': '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:\n\n* Can anomalies in visual and auditory sensory processing serve as early markers of psychosis risk?\n* How are these sensory anomalies related to clinical symptom severity and emotional recognition deficits?\n\nResearchers 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.\n\nParticipants will:\n\n* 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.\n* Undergo electrophysiological assessments of retinal function using flash stimulation to record retinal potentials (a-wave, b-wave, phNR, oscillatory potentials).\n* Provide demographic, clinical, and neuropsychological data during study visits.\n* For CHR participants, attend follow-up visits up to 6 months post initial assessments to evaluate psychotic symptom progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\nAll groups:\n\n* Age between 18 and 30 years\n* Normal or corrected-to-normal visual acuity\n* Affiliated with or dependent on a social security health insurance plan\n* Provided informed consent and co-signed the study consent form with the investigator\n* Proficient in French\n\nControl group (TEM) specific criteria:\n\n* No current psychiatric disorder (DSM-IV Axis I), except anxiety disorders\n* No lifetime history of (hypo)manic episodes or psychotic disorders\n* No first-degree family history of schizophrenia spectrum disorders\n* 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\n\nClinical High-Risk (CHR) group specific criteria:\n\n-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\n\nFirst-Episode Psychosis (PEP) group specific criteria:\n\n-Meet PEP criteria according to CAARMS (psychosis threshold reached)\n\nExclusion criteria:\n\n* Pregnant, postpartum, or breastfeeding women\n* Individuals deprived of liberty by judicial or administrative decision\n* Individuals in a life-threatening emergency\n* Adults under legal protection measures\n* Adults unable to provide consent and not under legal protection\n* Impairment that makes participation in the study or understanding of information difficult or impossible\n* Alcohol dependence (AUDIT score ≥12 for men, ≥11 for women)\n* Current substance use disorder (DAST score \\>6)\n* Cannabis use disorder (CUDIT-R score ≥13)\n* History of neurological disorders, including progressive neurological disease\n* Progressive retinal disease\n* Chronic glaucoma\n* Ophthalmologic conditions affecting visual acuity\n* Current eye infection\n* Hearing disorders affecting auditory acuity\n\nCriteria incompatible with the electroretinographic device:\n\n* Presence of photosensitive epilepsy\n* Allergy to components of the electrode gel\n* Behavioral problems causing extreme agitation or aggression\n* Eye or surrounding tissue lesions that may come into contact with the device'}, 'identificationModule': {'nctId': 'NCT07446569', 'acronym': 'PRIOR-ePSY', 'briefTitle': 'Perception and Integration of Sensory Information in the Early Stages of Psychosis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Psychothérapique de Nancy'}, 'officialTitle': 'Perception and Integration of Sensory Information in the Early Stages of Psychosis', 'orgStudyIdInfo': {'id': '2024-A02456-41'}, 'secondaryIdInfos': [{'id': 'RIPH 2024-04', 'type': 'OTHER', 'domain': 'centre psychothérapique de Nancy'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'observational behavioral and electrophysiological assessments', 'interventionNames': ['Behavioral: behavioral tasks', 'Device: Electroretinography', 'Diagnostic Test: Comprehensive Assessment of At Risk Mental States (CAARMS)', 'Behavioral: Neuropsychological tests']}], 'interventions': [{'name': 'behavioral tasks', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['observational behavioral and electrophysiological assessments']}, {'name': 'Electroretinography', 'type': 'DEVICE', 'description': 'Participants will additionally undergo electrophysiological recordings of retinal function (a-wave, b-wave, phNR, oscillatory potentials) using flash stimulation.', 'armGroupLabels': ['observational behavioral and electrophysiological assessments']}, {'name': 'Comprehensive Assessment of At Risk Mental States (CAARMS)', 'type': 'DIAGNOSTIC_TEST', 'description': 'All participants will be assessed using the CAARMS in order to evaluate their symptoms and classify them into either the CHR or FEP group', 'armGroupLabels': ['observational behavioral and electrophysiological assessments']}, {'name': 'Neuropsychological tests', 'type': 'BEHAVIORAL', 'description': 'TAP attention and working memory test, fNART, VOSP, Verbal fluency test.', 'armGroupLabels': ['observational behavioral and electrophysiological assessments']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69678', 'city': 'Bron', 'country': 'France', 'contacts': [{'name': 'Frédéric HAESEBAERT, PU.PH', 'role': 'CONTACT', 'email': 'Frederic.HAESEBAERT@ch-le-vinatier.fr', 'phone': '04 37 91 55 55'}, {'name': 'Frédéric HAESEBAERT, PU.PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Le Vinatier', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '54520', 'city': 'Laxou', 'country': 'France', 'contacts': [{'name': 'Mélissa FENOT', 'role': 'CONTACT', 'email': 'Melissa.FENOT@cpn-laxou.com', 'phone': '0383925267'}, {'name': 'Naoual MELLOUKI BENDIMRED, PhD', 'role': 'CONTACT', 'email': 'unic@cpn-laxou.com', 'phone': '0383925267', 'phoneExt': '33'}, {'name': 'Vincent LAPRÉVOTE, PU.PH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'florent BERNARDIN, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Psychothérapique de Nancy', 'geoPoint': {'lat': 48.68372, 'lon': 6.14929}}, {'zip': '38120', 'city': 'Saint-Égrève', 'country': 'France', 'contacts': [{'name': 'Clément DONDE, PU.PH', 'role': 'CONTACT', 'email': 'cdondecoquelet@chu-grenoble.fr', 'phone': '04 76 56 42 56'}, {'name': 'Clément DONDE, PU.PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Alpes-Isère', 'geoPoint': {'lat': 45.23313, 'lon': 5.68154}}, {'zip': '42270', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'contacts': [{'name': 'ERIC FAKRA, PU.PH', 'role': 'CONTACT', 'email': 'Eric.Fakra@chu-st-etienne.fr', 'phone': '0477127840'}, {'name': 'Eric FAKRA, PU.PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de Saint Etienne', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}], 'centralContacts': [{'name': 'Mélissa FENOT', 'role': 'CONTACT', 'email': 'Melissa.FENOT@cpn-laxou.com', 'phone': '0383925267'}, {'name': 'Naoual MELLOUKI BENDIMRED, PhD', 'role': 'CONTACT', 'email': 'unic@cpn-laxou.com', 'phone': '0383925267', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Vincent LAPRÉVOTE, PU.PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Psychothérapique de Nancy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Psychothérapique de Nancy', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}