[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586853":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":97,"collaborators":26,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":101,"sex":107,"minAge":108,"maxAge":26,"enrollmentInfo":109,"targetDuration":26,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Istituti Clinici Scientifici Maugeri SpA","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Prismatic adaptation group","EXPERIMENTAL","Patients receiving treatment with prismatic lenses and serious games lasting 10 days over a span of 2 weeks, for 40 minutes each session. This training will be administered using a class I medical device SaMD (Software as a Medical Device) associated to prisms.",[13,14],"Device: PRISMATIC ADAPTATION","Device: Serious games",{"label":16,"type":17,"description":18,"interventionNames":19},"Control group","SHAM_COMPARATOR","patients receiving the same serious games for 10 days over a span of 2 weeks, withouth prismatic adaptation session.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","PRISMATIC ADAPTATION","The experimental treatment includes a session of prismatic adaptation, in which patients, wearing priasmatic lenses, performs pointing exercises using an 11'' tablet. The visual target is represented by a black squares randomly presented in one of three spatial positions of the tablet's screen (in the centre of the screen or at 21° to the right or to the left space). Taking into account the type of lesion resulting from traumatic brain injury, the prismatic deviation induced by the lenses will be changed alternately from right to left. Then patients will wear rightward prism lenses for 5 days and leftward prism lenses for other 5 days. The prismatic deviation will be randomized.\n\nFollowing these prismatic adaptation, lasting 10 minutes, cognitive training with serious games will be performed, for the remaining 30 minutes.",[9],null,{"type":22,"name":28,"description":18,"armGroupLabels":29,"otherNames":26},"Serious games",[16,9],[31],{"name":32,"affiliation":33,"role":34},"Simona Spaccavento","Istituti Clinici Scientifici Maugeri IRCCS","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Simona Spaccavento, Psychologist","CONTACT","+393332783524","simona.spaccavento@icsmaugeri.it",[42,54,61,73,85],{"facility":33,"status":43,"city":44,"state":26,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":26},"RECRUITING","Bari","70124","Italy","IT",{"type":49,"coordinates":50},"Point",[51,52],16.86982,41.12066,{"lat":52,"lon":51},{"facility":33,"status":43,"city":44,"state":26,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":55,"geoPoint":57,"contacts":58},{"type":49,"coordinates":56},[51,52],{"lat":52,"lon":51},[59],{"name":37,"role":38,"phone":60,"phoneExt":26,"email":40},"+39332783524",{"facility":33,"status":43,"city":62,"state":26,"zip":63,"country":46,"countryCode":47,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Pavia","27100",{"type":49,"coordinates":65},[66,67],9.15917,45.19205,{"lat":67,"lon":66},[70],{"name":71,"role":38,"phone":26,"phoneExt":26,"email":72},"Marina Rita Manera, Psychologist","marina.manera@icsmaugeri.it",{"facility":33,"status":43,"city":74,"state":26,"zip":75,"country":46,"countryCode":47,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Sciacca","92019",{"type":49,"coordinates":77},[78,79],13.08399,37.50693,{"lat":79,"lon":78},[82],{"name":83,"role":38,"phone":26,"phoneExt":26,"email":84},"Stefania Ruvolo, Psychologist","stefania.ruvolo@icsmaugeri.it",{"facility":33,"status":43,"city":86,"state":26,"zip":87,"country":46,"countryCode":47,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Telese Terme","82037",{"type":49,"coordinates":89},[90,91],14.52681,41.21752,{"lat":91,"lon":90},[94],{"name":95,"role":38,"phone":26,"phoneExt":26,"email":96},"Pasquale Moretta, Psychologist","pasquale.moretta@icsmaugeri.it",{"type":98,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100586853","prismatic-adaptation-in-cognitive-rehabilitation-100586853",false,"NCT06920784","Prismatic Adaptation in Cognitive Rehabilitation","Prismatic Adaptation for Cognitive Rehabiliation in Traumatic Brain Injury Patients","PACoR-TBI","Inclusion Criteria:\n\n* Age \\>18 years\n* Traumatic brain injury (TBI)\n* Rancho Level of Cognitive Functioning (LCF) for TBI patients \\> 4\n* Admission within 90 days from the onset\n\nExclusion Criteria:\n\n* Unilateral Spatial Neglect\n* Aphasia\n* Severe vigilance deficits\n* Severe verbal comprehension deficits\n* Motor deficits of both hands\n* Previous neurological stroke\n* Previous neurological disease\n* Previous psychiatric disease\n* Use of alcohol or drugs\n* Severe visual deficits\n* Premorbid dementia","ALL","18 Years",{"count":110,"type":111},50,"ESTIMATED","INTERVENTIONAL",[114],"NA","The study aims to evaluate the effects of prismatic adaptation and then of a novel rehabilitation protocol that combines PA and Serious Games on cognitive and behavioural deficits in patients with traumatic brain injury , compared to a rehabilitation training without prismatic adaptation.\n\nMoreover, this study aims to assess the impact of this rehabilitation protocol on functional cognitive outcomes.\n\nHypothesis Hypothesis 1 (H1): It is postulated that the utilization of Prismatic Adaptation Treatment (PAT) has a positive impact on the enhancement of cognitive outcome among patients suffering from TBI\n\nHypothesis 2 (H2): It is hypothesized that there will be discernible alterations in resting-state Electroencephalography (EEG) patterns between the initial assessment point (T0) and the subsequent measurement during the course of treatment (T1) in individuals diagnosed with TBI\n\nAssessment times of outcome measures will be conducted before the experimental treatment (T0) and after the 10 rehabilitation sessions (T1).\n\nPatients will be randomized into two groups:\n\n1. Experimental group: Patients receiving treatment with prismatic lenses and serious games lasting 10 days over a span of 2 weeks, for 40 minutes each session.\n2. Control group: patients receiving the same serious games for 10 days over a span of 2 weeks, withouth prismatic adaptation session.\n\nBoth groups will receive also the standard cognitive rehabilitation for the detected deficits, using paper and pen materials.\n\nEach rehabiliation session will last aproximately 1 hour for 5 days a week for 2 weeks.",[117],"Traumatic Brain Injury",[117,119,120,121],"prismatic adaptation","cognitive rehabilitation","serious games","2026-03-24",{"date":124,"type":125},"2026-03-25","ACTUAL",{"date":127,"type":125},"2024-11-07",{"date":129,"type":111},"2026-12-31",{"name":5,"class":6},5]