[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598872":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":42,"locations":48,"responsibleParty":199,"collaborators":46,"id":201,"slug":202,"hasResults":203,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":203,"sex":209,"minAge":210,"maxAge":46,"enrollmentInfo":211,"targetDuration":46,"studyType":214,"phases":215,"briefSummary":217,"conditions":218,"keywords":220,"overallStatus":226,"whyStopped":46,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},{"fullName":5,"class":6},"Fondazione IRCCS San Gerardo dei Tintori","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Stimulated group","EXPERIMENTAL","taVNS stimulation using the Parasym device or sham stimulation will be applied from the time of enrolment (between 7 to 15 days since admission in ICU) until day 90 post-enrolment. Active stimulations will be carried out daily for 60 minutes twice daily during the acute phase and daily during the rehabilitation phase The stimulation waveform includes trains of pulses with widths of 200 µs and repetition rate of 20 Hz (Nurosym proprietary waveform); current delivery will be set at a predefined therapeutic level below 0.25 W\u002Fcm² (Watts per centimeter squared), that being the defined risk threshold for a thermal burn. The device adjusts stimulation intensity at 0.8 mA steps; the starting intensity will be set at 16 mA (level 20).",[13],"Device: stimulated group",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","SHAM_COMPARATOR","The Parasym device will be positioned on the patients as for the stimulated group (60 minutes twice daily during the acute phase - two sessions, one in the morning and one in the afternoon), and once daily (single session) during the rehabilitation phase but it won't be switched on.",[19],"Device: Sham (No Treatment)",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","stimulated group","Participants will be randomly assigned to receive either taVNS applied to the tragus of the ear or a sham stimulation from the time of randomization for 90 days. Active simulations will be carried out daily using the Parasym device for 60 minutes twice daily during the acute phase (two sessions, one in the morning and one in the afternoon), and once daily (single session) during the rehabilitation phase. The stimulation waveform includes trains of pulses with widths of 200 µs and repetition rate of 20 Hz (Nurosym proprietary waveform); current delivery will be set at a predefined therapeutic level below 0.25 W\u002Fcm² (Watts per centimeter squared), that being the defined risk threshold for a thermal burn. The device adjusts stimulation intensity at 0.8 mA steps; the starting intensity will be set at 16 mA (level 20).",[9],[27],"experimental arm",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Sham (No Treatment)","The sham stimulation involves placing the electrode on the same site without delivering any electrical current. The device will be applied to the tragus without electrical current delivered from the time of randomization for 90 days (i.e., the time of randomization coincides with the first stimulation session).",[15],[33],"control group",[35,39],{"name":36,"affiliation":37,"role":38},"Giuseppe Citerio, MD, Full Professor","University of Milano-Bicocca \u002F Fondazione IRCCS San Gerardo dei Tintori","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":5,"role":41},"Alberto Addis, MD","STUDY_DIRECTOR",[43],{"name":36,"role":44,"phone":45,"phoneExt":46,"email":47},"CONTACT","+390392334316",null,"giuseppe.citerio@unimib.it",[49,66,80,93,107,120,133,146,159,173,186],{"facility":50,"status":46,"city":51,"state":52,"zip":46,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"ASST degli Spedali Civili di Brescia","Brescia","BS","Italy","IT",{"type":56,"coordinates":57},"Point",[58,59],10.21472,45.53558,{"lat":59,"lon":58},[62,65],{"name":63,"role":44,"phone":46,"phoneExt":46,"email":64},"Francesco Rasulo, MD, Professor","francesco.rasulo@unibs.it",{"name":63,"role":38,"phone":46,"phoneExt":46,"email":46},{"facility":5,"status":46,"city":67,"state":68,"zip":69,"country":53,"countryCode":54,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Monza","MB","20900",{"type":56,"coordinates":71},[72,73],9.27246,45.58005,{"lat":73,"lon":72},[76,79],{"name":40,"role":44,"phone":77,"phoneExt":46,"email":78},"+390392334335","alberto.addis@irccs-sangerardo.it",{"name":40,"role":38,"phone":46,"phoneExt":46,"email":46},{"facility":81,"status":46,"city":82,"state":46,"zip":46,"country":53,"countryCode":54,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"ASST Papa Giovanni XXIII","Bergamo",{"type":56,"coordinates":84},[85,86],9.66721,45.69601,{"lat":86,"lon":85},[89,92],{"name":90,"role":44,"phone":46,"phoneExt":46,"email":91},"Paolo Gritti, MD","pgritti@asst-pg23.it",{"name":90,"role":38,"phone":46,"phoneExt":46,"email":46},{"facility":94,"status":46,"city":95,"state":46,"zip":46,"country":53,"countryCode":54,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"ASST Lariana Ospedale S. Anna","Como",{"type":56,"coordinates":97},[98,99],9.0832,45.80819,{"lat":99,"lon":98},[102,105],{"name":103,"role":44,"phone":46,"phoneExt":46,"email":104},"Simone M Zerbi, MD","simonemaria.zerbi@asst-lariana.it",{"name":106,"role":38,"phone":46,"phoneExt":46,"email":46},"Simone M. Zerbi, MD",{"facility":108,"status":46,"city":109,"state":46,"zip":46,"country":53,"countryCode":54,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Ospedale Policlinico San Martino IRCCS","Genova",{"type":56,"coordinates":111},[112,113],11.87211,45.21604,{"lat":113,"lon":112},[116,119],{"name":117,"role":44,"phone":46,"phoneExt":46,"email":118},"Chiara Robba, MD, Professor","kiarobba@gmail.com",{"name":117,"role":38,"phone":46,"phoneExt":46,"email":46},{"facility":121,"status":46,"city":122,"state":46,"zip":46,"country":53,"countryCode":54,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"ASST Grande Ospedale Metropolitano Niguarda","Milan",{"type":56,"coordinates":124},[125,126],12.59836,42.78235,{"lat":126,"lon":125},[129,132],{"name":130,"role":44,"phone":46,"phoneExt":46,"email":131},"Arturo Chieregato, MD","arturo.chieregato@ospedaleniguarda.it",{"name":130,"role":38,"phone":46,"phoneExt":46,"email":46},{"facility":134,"status":46,"city":135,"state":46,"zip":46,"country":53,"countryCode":54,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Azienda Ospedaliera Università di Padova","Padova",{"type":56,"coordinates":137},[138,139],11.14261,44.38225,{"lat":139,"lon":138},[142,145],{"name":143,"role":44,"phone":46,"phoneExt":46,"email":144},"Marina Munari, MD","marina.munari@aopd.veneto.it",{"name":143,"role":38,"phone":46,"phoneExt":46,"email":46},{"facility":147,"status":46,"city":148,"state":46,"zip":46,"country":53,"countryCode":54,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Azienda Ospedaliera Universitaria di Parma","Parma",{"type":56,"coordinates":150},[151,152],10.32618,44.79935,{"lat":152,"lon":151},[155,158],{"name":156,"role":44,"phone":46,"phoneExt":46,"email":157},"Edoardo Picetti, MD","edo74icuwild@hotmail.com",{"name":156,"role":38,"phone":46,"phoneExt":46,"email":46},{"facility":160,"status":46,"city":161,"state":46,"zip":46,"country":53,"countryCode":54,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","Roma",{"type":56,"coordinates":163},[164,165],11.10642,44.99364,{"lat":165,"lon":164},[168,171],{"name":169,"role":44,"phone":46,"phoneExt":46,"email":170},"Anselmo Caricato, MD, Professor","anselmo.caricato@unicatt.it",{"name":172,"role":38,"phone":46,"phoneExt":46,"email":46},"Anselmo Caricato, MD",{"facility":174,"status":46,"city":175,"state":46,"zip":46,"country":53,"countryCode":54,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Humanitas Research Hospital","Rozzano",{"type":56,"coordinates":177},[178,179],9.1559,45.38193,{"lat":179,"lon":178},[182,185],{"name":183,"role":44,"phone":46,"phoneExt":46,"email":184},"Federico Villa, MD","federico.villa@humanitas.it",{"name":183,"role":38,"phone":46,"phoneExt":46,"email":46},{"facility":187,"status":46,"city":188,"state":46,"zip":46,"country":53,"countryCode":54,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"ASST Sette Laghi Ospedale di Circolo e Fondazione Macchi","Varese",{"type":56,"coordinates":190},[191,192],8.82511,45.82058,{"lat":192,"lon":191},[195,198],{"name":196,"role":44,"phone":46,"phoneExt":46,"email":197},"Luca Cabrini, MD","l.cabrini@asst-settelaghi.it",{"name":196,"role":38,"phone":46,"phoneExt":46,"email":46},{"type":200,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100598872","vagal-nerve-stimulation-to-treat-disorders-of-consciousness-100598872",false,"NCT07077135","Vagal Nerve Stimulation to Treat Disorders of Consciousness","Transcutaneous Vagal Nerve Stimulation to Treat Disorders of Consciousness","REVELATION","Inclusion Criteria:\n\n* Age ≥ 18 years old;\n* any acquired cerebral damage of any known etiology;\n* diagnosis of coma, UWS, or MCS with the corresponding basal CRS-R (Coma Recovery Scale-Revised) score performed during the screening period from 7 to 15 days since admission in ICU;\n* intact ear skin;\n* availability of the device.\n\nExclusion Criteria:\n\n* Patients with severe hemodynamic, respiratory, infectious, or neurological instability requiring active treatment requiring mechanical ventilation or vasoactive drugs or pending acute neurosurgical interventions;\n* Need for deep sedation, including general anesthetics (e.g., propofol) or a combination of central-acting sedatives;\n* Documented pregnancy;\n* Active implant (e.g., pacemaker, cochlear implant);\n* History of previous serious neurological disability before the brain injury;\n* Seizures or status epilepticus as cause sustaining the disorder of consciousness;\n* Patients already enrolled in another ongoing interventional trial.","ALL","18 Years",{"count":212,"type":213},106,"ESTIMATED","INTERVENTIONAL",[216],"NA","This interventional study aims to assess the clinical efficacy of transcutaneous auricular vagal nerve stimulation (taVNS) against sham stimulation on the recovery of consciousness in patients with disorders of consciousness. The main question it aims to answer is: will taVNS improve patients' behavioral scores or will it produce an improvement in the diagnosed level of consciousness? Researchers will compare the results with non-stimulated unconscious patients to see if the re-gain of consciousness is faster in the treated group.\n\nParticipants will undergo taVNS stimulation using the Parasym device or sham stimulation will be applied from the time of enrolment.\n\nActive stimulations will be carried out for 60 minutes twice daily during the acute phase and daily during the rehabilitation phase.",[219],"Disorder of Consciousness",[221,222,223,224,225],"vagal nerve stimulation","transcutaneous","auricolar","disorder of consciousness","coma","NOT_YET_RECRUITING","2025-07-11",{"date":229,"type":230},"2025-07-22","ACTUAL",{"date":232,"type":213},"2025-09-01",{"date":234,"type":213},"2028-09-01",{"name":5,"class":6},11]