[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647752":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":25,"centralContacts":30,"locations":38,"responsibleParty":91,"collaborators":94,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":10,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":10,"enrollmentInfo":106,"targetDuration":10,"studyType":109,"phases":10,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":123,"whyStopped":10,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Fondazione Don Carlo Gnocchi ETS","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with severe acquired brain injury and disorders of consciousness",null,"Consecutive adult inpatients with severe acquired brain injury and a stable diagnosis of disorder of consciousness admitted to one of the four participating centers and meeting eligibility criteria. All eligible participants will undergo SWADOC validation assessments. A nested subgroup of the first 22 participants who also meet BERA-specific criteria will undergo BERA validation assessments.",[13,14],"Diagnostic Test: Italian SWallowing Assessment in Disorders of Consciousness (SWADOC)","Diagnostic Test: Italian Brief Evaluation of Receptive Aphasia (BERA)",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"DIAGNOSTIC_TEST","Italian SWallowing Assessment in Disorders of Consciousness (SWADOC)","Structured clinical assessment of oral and pharyngeal swallowing components in patients with disorders of consciousness. The Italian version will be administered and scored by trained examiners to evaluate inter-rater and test-retest reliability.",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"Italian Brief Evaluation of Receptive Aphasia (BERA)","Brief clinical assessment of receptive language abilities, including phonology, semantics, and morphosyntax. Responses are based on visual\u002Feye-movement behavior, allowing assessment of patients unable to communicate verbally or through reliable motor responses. It will be administered to the nested subgroup meeting BERA-specific criteria.",[9],[26],{"name":27,"affiliation":28,"role":29},"Alfonso Magliacano, PhD","Fondazione Don Carlo Gnocchi","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":10,"email":34},"CONTACT","393387389414","amagliacano@dongnocchi.it",{"name":36,"role":32,"phone":10,"phoneExt":10,"email":37},"Anna Estraneo, MD","aestraneo@dongnocchi.it",[39,55,68,81],{"facility":40,"status":10,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Polo Specialistico Riabilitativo Fondazione Don Gnocchi","Sant'Angelo dei Lombardi","AV","83054","Italy","IT",{"type":47,"coordinates":48},"Point",[49,50],15.17535,40.92937,{"lat":50,"lon":49},[53],{"name":54,"role":32,"phone":33,"phoneExt":10,"email":34},"Alfonso Magliacano",{"facility":56,"status":10,"city":57,"state":10,"zip":10,"country":44,"countryCode":45,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"IRCCS Fondazione Don Carlo Gnocchi","Florence",{"type":47,"coordinates":59},[60,61],11.24626,43.77925,{"lat":61,"lon":60},[64],{"name":65,"role":32,"phone":66,"phoneExt":10,"email":67},"Bahia Hakiki","3905573931","bhakiki@dongnocchi.it",{"facility":69,"status":10,"city":70,"state":10,"zip":10,"country":44,"countryCode":45,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"IRCCS Istituto Neurologico Carlo Besta","Milan",{"type":47,"coordinates":72},[73,74],12.59836,42.78235,{"lat":74,"lon":73},[77],{"name":78,"role":32,"phone":79,"phoneExt":10,"email":80},"Matilde Leonardi","390223941","Matilde.Leonardi@istituto-besta.it",{"facility":82,"status":10,"city":70,"state":10,"zip":10,"country":44,"countryCode":45,"cosmosGeoPoint":83,"geoPoint":85,"contacts":86},"IRCCS SM Nascente Fondazione Don Carlo Gnocchi",{"type":47,"coordinates":84},[73,74],{"lat":74,"lon":73},[87],{"name":88,"role":32,"phone":89,"phoneExt":10,"email":90},"Angela Comanducci","3902403081","acomanducci@dongnocchi.it",{"type":92,"investigatorFullName":54,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Researcher",[95],{"name":96,"class":6},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta","100647752","cross-cultural-adaptation-and-multicenter-validation-of-the-italian-versions-of-the-brief-evaluation-of-receptive-aphasia-bera-and-swallowing-assessment-in-disorders-of-consciousness-swadoc-100647752",false,"NCT07711119","Cross-cultural Adaptation and Multicenter Validation of the Italian Versions of the Brief Evaluation of Receptive Aphasia (BERA) and SWallowing Assessment in Disorders of Consciousness (SWADOC)","Adattamento Trans-culturale e Validazione Multicentrica Della Versione Italiana Delle Scale Brief Evaluation of Receptive Aphasia (BERA) e SWallowing Assessment in Disorders of Consciousness (SWADOC)","Inclusion Criteria:\n\n* Age \\>= 18 years.\n* Native Italian speaker.\n* Diagnosis of severe acquired brain injury.\n* At least 28 days since the acute event.\n* For SWADOC validation: stable clinical diagnosis of disorder of consciousness, including UWS, MCS, or EMCS, assessed with the Coma Recovery Scale-Revised repeated at least five times over two weeks.\n* For BERA validation: stable clinical diagnosis of MCS or EMCS assessed with the Coma Recovery Scale-Revised repeated at least five times over two weeks.\n* For BERA validation: presence of visual fixation and\u002For visual pursuit assessed with the Coma Recovery Scale-Revised.\n* No remote history of neurological, neurodegenerative, or psychiatric disease; for SWADOC validation, no remote history of otorhinolaryngological disease.\n* Written informed consent provided by the primary caregiver\u002Flegal representative according to local regulations.\n\nExclusion Criteria:\n\n* Occurrence of a second cerebral event between enrollment and data collection.\n* Unstable general clinical condition preventing assessment, including but not limited to need for ventilatory support, severe infection, or status epilepticus.","ALL","18 Years",{"count":107,"type":108},79,"ESTIMATED","OBSERVATIONAL","Patients with severe acquired brain injury may evolve from coma into prolonged disorders of consciousness. In these patients, residual language comprehension and swallowing abilities are difficult to evaluate because standard assessments often depend on verbal or motor responses. The Brief Evaluation of Receptive Aphasia (BERA) assesses receptive language abilities through visual\u002Feye-movement responses, whereas the SWallowing Assessment in Disorders of Consciousness (SWADOC) assesses oral and pharyngeal components of swallowing in patients with disorders of consciousness. This national multicenter observational study aims to perform the Italian cross-cultural adaptation and validation of BERA and SWADOC. Consecutive adult inpatients with severe acquired brain injury and disorders of consciousness will be recruited from four Italian centers. SWADOC will be administered to 57 patients, and BERA will be administered to a nested subgroup of 22 patients who meet additional criteria. Inter-rater reliability, test-retest reliability over 24 hours, and convergent validity with Coma Recovery Scale-Revised scores will be analyzed.",[112,113],"Consciousness Disorders","Severe Acquired Brain Injury",[115,116,117,118,119,120,121,122],"disorders of consciousness","severe acquired brain injury","BERA","Brief Evaluation of Receptive Aphasia","SWADOC","swallowing assessment","Receptive Aphasia","rehabilitation","NOT_YET_RECRUITING","2026-07-14",{"date":126,"type":127},"2026-07-17","ACTUAL",{"date":129,"type":108},"2026-09-01",{"date":131,"type":108},"2028-08-31",{"name":54,"class":6},4]