protocolSection identificationModule nctId: NCT06323031, orgStudyIdInfo id: Blink-DoC, briefTitle: Spontaneous Eye Blinking in Disorders of Consciousness, acronym: Blink-DoC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Fondazione Don Carlo Gnocchi Onlus, class: OTHER, collaborators name: Therapiezentrum Burgau, collaborators name: University of Liege, collaborators name: University Hospital Munich, collaborators name: VITHAS Valencia (Spain), collaborators name: Azienda Ospedaliera Universitaria Ferrara, collaborators name: Ludwig-Maximilians - University of Munich, descriptionModule briefSummary: Differential diagnosis between Unresponsive Wakefulness Syndrome (UWS) and Minimally Conscious State (MCS) is complicated due to severe cognitive and/or sensorimotor deficits in these patients. In this study the investigators aimed at exploring the diagnostic and prognostic validity of spontaneous eye blinking parameters (rate, amplitude, duration, variability) in a sample of patients with Disorders of Consciousness (DoC).This is a multi-center prospective observational study conducted in patients with Severe Acquired Brain Injury (sABI) and DoC admitted to 8 European participating centers, with clinical data collection not deviating from routine practice. The study is non-commercial and will have a maximum total duration of 24 months., conditionsModule conditions: Disorders of Consciousness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Clinical Diagnosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Coma Science Group, GIGA-Consciousness, University of Liege, city: Liege, zip: 4000, country: Belgium, contacts name: Olivia Gosseries, PhD, role: CONTACT, email: ogosseries@uliege.be, contacts name: Olivia Gosseries, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Aurore Thibaut, PhD, role: SUB_INVESTIGATOR, contacts name: Youssra Mezoudi, M.Sc., role: SUB_INVESTIGATOR, geoPoint lat: 50.63373, lon: 5.56749, locations facility: Therapiezentrum Burgau, city: Burgau, zip: 89331, country: Germany, contacts name: Andreas Bender, MD, role: CONTACT, email: a.bender@therapiezentrum-burgau.de, contacts name: Andreas Bender, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Martin Rosenfelder, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 48.43159, lon: 10.40989, locations facility: Dipartimento di Neurologia, LMU Hospital, LMU Munich, city: Munich, zip: 81377, country: Germany, contacts name: Konstantinos Dimitriadis, role: CONTACT, email: konstantin.dimitriadis@med.unimuenchen.de, contacts name: Konstantinos Dimitriadis, role: PRINCIPAL_INVESTIGATOR, contacts name: Moritz Schmidbauer, role: SUB_INVESTIGATOR, contacts name: Julia Zibold, role: SUB_INVESTIGATOR, geoPoint lat: 48.13743, lon: 11.57549, locations facility: Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS, city: Sant'Angelo dei Lombardi, state: AV, zip: 83054, country: Italy, contacts name: Anna Estraneo, PhD, role: CONTACT, phone: 3396418648, phoneExt: 39, email: aestraneo@dongnocchi.it, contacts name: Alfonso Magliacano, PhD, role: CONTACT, phone: 3387389414, phoneExt: 39, email: amagliacano@dongnocchi.it, contacts name: Anna Estraneo, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Alfonso Magliacano, PhD, role: SUB_INVESTIGATOR, contacts name: Giovanni Scarano, BS, role: SUB_INVESTIGATOR, geoPoint lat: 40.92937, lon: 15.17535, locations facility: Unità Gravi Cerebrolesioni - Dipartimento Neuroscienze - Azienda Ospedaliera - Universitaria Ferrara, city: Ferrara, zip: 44124, country: Italy, contacts name: Susanna Lavezzi, role: CONTACT, email: s.lavezzi@ospfe.it, contacts name: Susanna Lavezzi, role: PRINCIPAL_INVESTIGATOR, contacts name: Valentina Bonsangue, role: SUB_INVESTIGATOR, contacts name: Sofia Straudi, role: SUB_INVESTIGATOR, geoPoint lat: 44.83804, lon: 11.62057, locations facility: IRCCS Fondazione Don Gnocchi ONLUS, city: Florence, zip: 50143, country: Italy, contacts name: Bahia Hakiki, PhD, role: CONTACT, email: bhakiki@dongnocchi.it, contacts name: Bahia Hakiki, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Andrea Mannini, PhD, role: SUB_INVESTIGATOR, contacts name: Piergiuseppe Liuzzi, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 43.77925, lon: 11.24626, locations facility: IRCCS Santa Maria Nascente Fondazione Don Gnocchi ONLUS, city: Milan, zip: 20148, country: Italy, contacts name: Angela Comanducci, PhD, role: CONTACT, email: acomanducci@dongnocchi.it, contacts name: Angela Comanducci, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Tiziana Atzori, role: SUB_INVESTIGATOR, contacts name: Chiara-Camilla Derchi, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Instituto de Rehabilitación Neurológica IRENEA, city: Valencia, zip: 46007, country: Spain, contacts name: Enrique Noé, MD, role: CONTACT, email: enoe@comv.es, contacts name: Enrique Noé, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Roberto Llorens, PhD, role: SUB_INVESTIGATOR, contacts name: Alejandro Galvao, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False