[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590304":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":57,"studyPopulation":50,"armGroups":58,"interventions":71,"overallOfficials":81,"centralContacts":86,"locations":91,"responsibleParty":120,"collaborators":122,"id":126,"slug":50,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":133,"sex":134,"minAge":135,"maxAge":50,"enrollmentInfo":136,"targetDuration":50,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":94,"whyStopped":50,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"IRCCS San Camillo, Venezia, Italy","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":46,"otherOutcomes":50},[9,13,16,19,22,24,27,29,31,34,37,40,43],{"measure":10,"description":11,"timeFrame":12},"Change pre-post rehabilitation in eye movements patterns during free viewing","Eye movements patterns described by fixations, saccades and blinks related features summarized by principal component analysis (PCA)","At day 0 and day 30 (i.e., end of the rehabilitation)",{"measure":14,"description":15,"timeFrame":12},"Change pre-post rehabilitation in Behavioral Inattention Test score","Neuropsychological test assessing visuospatial deficits",{"measure":17,"description":18,"timeFrame":12},"Change pre-post rehabilitation in Trail Making Test score","Neuropsychological test assessing visuospatial abilities, scored as the time to complete the task",{"measure":20,"description":21,"timeFrame":12},"Change pre-post rehabilitation in Posner Test reaction times","Neuropsychological test assessing visuospatial abilities, scored with the measured reaction times",{"measure":23,"description":15,"timeFrame":12},"Change pre-post rehabilitation in Attention Matrices Test",{"measure":25,"description":26,"timeFrame":12},"Change pre-post rehabilitation in Brief Visuospatial Memory Test Revised","Neuropsychological test assessing visuospatial memory",{"measure":28,"description":15,"timeFrame":12},"Change pre-post rehabilitation in Bells Test",{"measure":30,"description":15,"timeFrame":12},"Change pre-post rehabilitation in Apple Test score",{"measure":32,"description":33,"timeFrame":12},"Change pre-post rehabilitation in Comb and Razor Test","Neuropsychological test assessing functional activities to investigate spatial attention deficits",{"measure":35,"description":36,"timeFrame":12},"Change pre-post rehabilitation in Mental Number Interval Bisection","Neuropsychological test investigating spatial biases in the mental number line",{"measure":38,"description":39,"timeFrame":12},"Change pre-post rehabilitation in Anosognosia","Neuropsychological test investigating deficits awareness",{"measure":41,"description":42,"timeFrame":12},"Change pre-post rehabilitation in Load Test","Neuropsychological test assessing spatial attentional deficits with cognitive load as a moderator",{"measure":44,"description":45,"timeFrame":12},"Change pre-post rehabilitation in the Catherine-Bergego Scale score","Test assessing activities of daily living involving spatial attention",[47],{"measure":48,"description":49,"timeFrame":12},"Change pre-post rehabilitation in structural and functional connectivity","Structural and functional MRI connectivity maps",null,{"allocation":52,"interventionModel":53,"interventionModelDescription":50,"primaryPurpose":54,"observationalModel":50,"timePerspective":50,"maskingInfo":55},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":56,"maskingDescription":50,"whoMasked":50},"NONE","This study is divided into two parts concerning the diagnostic and treatment of visuospatial deficits in patients affected by unilateral stroke. Eye movements indices during free viewing of natural scenes will be correlated to the standard neuropsychological evaluation, describing the cognitive, motor and functional spectrum of patient status. Moreover, functional and structural neuroimaging will be exploited to identify neural correlates of patient eye movements characteristics. Ultimately, a subsample of randomly assigned participants, at the IRCCS San Camillo, will undergo a novel visual exploration training, in addition to the standard rehabilitation. This protocol consists of natural scene exploration guided by an auditory biofeedback system which tracks online parsed fixations. Concretely, the training maneuvers exploration toward salient regions of the presented image, as indicated by a normative sample. Changes in free viewing behavior, neuropsychological assessment and neuroimaging will be discussed compared to an active control group and a healthy sample.",[59,66],{"label":60,"type":61,"description":62,"interventionNames":63},"Intervention","EXPERIMENTAL","This group will undergo ten sessions of the experimental visual exploration protocol and the standard neuropsychological rehabilitation delivered in the clinical facility",[64,65],"Behavioral: Visual exploration training","Behavioral: Standard neuropsychological rehabilitation",{"label":67,"type":68,"description":69,"interventionNames":70},"Control","ACTIVE_COMPARATOR","This group will undergo the standard neuropsychological rehabilitation at the IRCCS San Camillo hospital",[65],[72,77],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":50},"BEHAVIORAL","Visual exploration training","Visual exploration of natural scenes guided by closed-loop auditory biofeedback through eye-tracking",[60],{"type":73,"name":78,"description":79,"armGroupLabels":80,"otherNames":50},"Standard neuropsychological rehabilitation","Standard rehabilitation delivered at the IRCCS San Camillo hospital",[67,60],[82],{"name":83,"affiliation":84,"role":85},"Marco Zorzi","San Camillo IRCCS, Venice, Italy","PRINCIPAL_INVESTIGATOR",[87],{"name":83,"role":88,"phone":89,"phoneExt":50,"email":90},"CONTACT","+39 049 827 6618","marco.zorzi@unipd.it",[92,108],{"facility":93,"status":94,"city":95,"state":96,"zip":50,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"Azienda Ospedaliera di Padova","RECRUITING","Padova","PD","Italy","IT",{"type":100,"coordinates":101},"Point",[102,103],11.14261,44.38225,{"lat":103,"lon":102},[106],{"name":107,"role":88,"phone":50,"phoneExt":50,"email":50},"Andrea Zangrossi",{"facility":109,"status":94,"city":110,"state":111,"zip":50,"country":97,"countryCode":98,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"IRCCS San Camillo","Venice-Lido","VE",{"type":100,"coordinates":113},[114,115],12.3742,45.4131,{"lat":115,"lon":114},[118],{"name":119,"role":88,"phone":50,"phoneExt":50,"email":50},"Valeria Camparini",{"type":85,"investigatorFullName":83,"investigatorTitle":121,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"Professor",[123,124],{"name":93,"class":6},{"name":125,"class":6},"University of Padova","100590304",false,"NCT06965673","Assessment of Eye Movements in Stroke Patients and Closed-loop Intervention","Eye-movement Dynamics During Free Viewing as a Biomarker for Assessment of Visuospatial Functions and for Closed-loop Rehabilitation in Stroke","EMS","Inclusion Criteria:\n\n* Vigilant\n* First unifocal ischemic or hemorragic stroke\n* Presence of maximum two lacunae, clinically silent, smaller than 15 mm. in the structural MRI\n* Evident symptoms in the visual, attentive, memory, motor or language domain supported by the radiological exam\n\nExclusion Criteria:\n\n* Previous stroke history, visible at the radiological exam\n* Multifocal deficit\n* Incapacity to remain vigilant during the required assessments\n* Claustrophobia and\u002For metallic objects which could prevent MRI acquisition\n* Presence of other neurological, psychiatric or medical conditions which may undermine interpretation of behavioral and neuroimaging results",true,"ALL","18 Years",{"count":137,"type":138},30,"ESTIMATED","INTERVENTIONAL",[141],"NA","The current study evaluates first the assumption that eye-movements during free viewing behavior are potential biomarkers of visuospatial deficits in stroke population. Second, it assesses the feasibility of a novel visual exploration training to ameliorate visuospatial deficits, by exploiting an auditory biofeedback system coupled with online parsed fixations.",[144],"Stroke",[146],"Visuospatial","2025-05-01",{"date":149,"type":150},"2025-05-11","ACTUAL",{"date":152,"type":150},"2023-04-01",{"date":154,"type":138},"2025-06",{"name":5,"class":6},2]