Nctid:
NCT06236399
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"CROSS_SECTIONAL", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>200}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-11-13", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-04", "completionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-04-08", "studyFirstSubmitDate"=>"2024-01-08", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-04-10", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Electroencephalographic (EEG) oscillatory amplitude", "timeFrame"=>"during the intervention", "description"=>"Amplitude of EEG oscillations in theta, alpha and beta frequency bands"}, {"measure"=>"Electroencephalographic (EEG) oscillatory frequency", "timeFrame"=>"during the intervention", "description"=>"Frequency of EEG oscillations in theta, alpha and beta frequency bands"}, {"measure"=>"Electroencephalographic (EEG) oscillatory phase coherence", "timeFrame"=>"during the intervention", "description"=>"Phase coherence of EEG oscillations in theta, alpha and beta frequency bands"}, {"measure"=>"Autism Quotient (AQ)", "timeFrame"=>"during the intervention", "description"=>"Personality questionnaire measuring subclinical autistic traits. Higher score mean worse outcome. Score range: min.= 0, max.= 50."}, {"measure"=>"Schizotypal Personality Questionnaire (SPQ)", "timeFrame"=>"during the intervention", "description"=>"Personality questionnaire measuring subclinical schizotypal traits. Higher score mean worse outcome. Score range: min.= 0, max.= 74."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Human Brain and Cognition"]}, "descriptionModule"=>{"briefSummary"=>"The study involved healthy volunteers (n= 200), in a single center, low-risk intervention protocol of a non-profit nature. The objective of the study is to investigate the neural mechanisms of visual perception and attention, with particular reference to neural oscillations, in the general population through electroencephalogram (EEG) recording and the administration of simple visual tasks on a PC. The study presented is not associated with risks, as EEG is a non-invasive technique for which there are no known contraindications or adverse reactions."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"35 years", "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"Healthy human volunteers", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* age between 18 and 35 years\n* able/willing to sign the informed consent\n* normal or corrected-to-normal vision and hearing\n\nExclusion Criteria:\n\n- history of severe/major neurological or psychiatric conditions"}, "identificationModule"=>{"nctId"=>"NCT06236399", "briefTitle"=>"An EEG Study on the Rhythmic Nature of Perception and Attention", "organization"=>{"class"=>"OTHER", "fullName"=>"Università Vita-Salute San Raffaele"}, "officialTitle"=>"EEG Study of the Rhythmic Nature of Human Visual Perception and Attention", "orgStudyIdInfo"=>{"id"=>"EEGVISION-01"}}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20132", "city"=>"Milan", "status"=>"RECRUITING", "country"=>"Italy", "contacts"=>[{"name"=>"Luca Ronconi", "role"=>"CONTACT", "email"=>"ronconi.luca@unisr.it", "phone"=>"0226434887"}], "facility"=>"IRCCS Ospedale San Raffaele", "geoPoint"=>{"lat"=>45.46427, "lon"=>9.18951}}], "centralContacts"=>[{"name"=>"Luca Ronconi, PhD", "role"=>"CONTACT", "email"=>"ronconi.luca@unisr.it", "phone"=>"0226434887", "phoneExt"=>"+39"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Università Vita-Salute San Raffaele", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor", "investigatorFullName"=>"Luca Ronconi", "investigatorAffiliation"=>"Università Vita-Salute San Raffaele"}}}}
