[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622583":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":25,"centralContacts":29,"locations":34,"responsibleParty":54,"collaborators":10,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":10,"eligibilityCriteria":62,"healthyVolunteers":59,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":69,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"IRCCS Centro Neurolesi Bonino Pulejo","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Responders",null,"A patient is classified as a \"responder\" if they meet at least one of the following criteria relative to baseline:\n\nI. An increase of ≥3 points on the Coma Recovery Scale-Revised (CRS-R) or a clinically relevant state transition (e.g., VS\u002FUWS → MCS; MCS → emergence from MCS \\[EMCS\\]).\n\nII. An increase of ≥10 points on the Functional Independence Measure (FIM) or ≥0.5 standard deviations (SD) from baseline.\n\nIII. An increase of ≥10 points on the Barthel Index or ≥0.5 SD from baseline.",[13],"Device: Multidisciplinary neurorehabilitation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Multidisciplinary neurorehabilitation","Patients will undergo one or more of the specified rehabilitative treatments, depending on the medical prescriptions issued. All treatments are non-invasive in nature and are administered within the hospital facility. The methods of treatment delivery vary depending on the patient's condition.",[9],[21,22,23,24],"Transcranial direct current stimulation","Transcranial Magnetic Stimulation","Multimodal Sensory Stimulation","Augmentative and alternative communication device with Eye-Tracking",[26],{"name":27,"affiliation":5,"role":28},"Davide Cardile, Psychologist","PRINCIPAL_INVESTIGATOR",[30],{"name":27,"role":31,"phone":32,"phoneExt":10,"email":33},"CONTACT","090 6012 8417","davide.cardile@irccsme.it",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"IRCCS Centro Neurolesi Bonino-Pulejo","RECRUITING","Messina","Sicily","98066","Italy","IT",{"type":44,"coordinates":45},"Point",[46,47],15.55256,38.19394,{"lat":47,"lon":46},[50],{"name":51,"role":31,"phone":52,"phoneExt":53,"email":33},"Davide Cardile, Neuropsychologist","09060128417","+39",{"type":28,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Davide Cardile","Psychologist","100622583","neurorehabilitation-in-patients-with-disorders-of-consciousness-multidimensional-ambispective-study-on-the-impact-of-single-and-combined-approaches-100622583",false,"NCT07385508","Neurorehabilitation in Patients With Disorders of Consciousness: Multidimensional Ambispective Study on the Impact of Single and Combined Approaches","Inclusion Criteria:\n\n* Diagnosis of VS\u002FMCS following ABI, according to clinical and neuroradiological findings.\n* Age between 18 and 90 years.\n* Adequate pulmonary gas exchange function (PaO₂ \u002F FiO₂ ratio ≥ 250).\n* Stable haemodynamic profile (absence of significant arterial variations in mean arterial pressure and\u002For heart rate).\n\nExclusion Criteria:\n\n* Diagnosis of DOC due to non-structural aetiopathogenesis.\n* Having previously undergone multiple rehabilitation cycles\n* Being affected by deafness and\u002For blindness\n* Having unstable intracranial pressure values\n* Having cerebral perfusion values below 60 mmHg\n* Having other concomitant medical conditions that could interfere with the rehabilitation","ALL","18 Years","90 Years",{"count":67,"type":68},140,"ESTIMATED","36 Months","OBSERVATIONAL","Disorders of consciousness (DOC), such as the vegetative state\u002Funresponsive wakefulness syndrome (VS\u002FUWS) and the minimally conscious state (MCS), represent severe clinical conditions arising from acquired brain injury (ABI), exerting a profound impact on patients, caregivers, and healthcare systems. The clinical heterogeneity, diagnostic challenges, and paucity of robust evidence on the comparative efficacy of rehabilitation interventions underscore the need for a deeper understanding of the underlying neurophysiological, cognitive, and biological mechanisms involved in consciousness recovery. This monocentric ambispective observational study aims to investigate the effects of advanced neurorehabilitation treatments-including multimodal sensory stimulation, non-invasive neuromodulation via transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (tDCS), and the use of augmentative and alternative communication (AAC) devices with eye-tracking-on various facets of residual consciousness in patients diagnosed with DOC admitted to the Neurorehabilitation Unit of the IRCCS Centro Neurolesi \"Bonino Pulejo\" in Messina.\n\nThe study design encompasses the collection of clinical and rehabilitation data from hospitalized patients undergoing treatment, both retrospectively and prospectively. Specifically, data from patients admitted and treated in the 36 months preceding study initiation, as well as those admitted and treated in the subsequent 36 months, will be included. Upon data collection, participants will be classified a posteriori as \"responders\" or \"non-responders\" based on whether they meet at least one of the following criteria: (I) an increase of ≥3 points on the Coma Recovery Scale-Revised (CRS-R) from baseline or a clinically relevant state transition (e.g., VS\u002FUWS → MCS; MCS → emergence from MCS \\[EMCS\\]); (II) an increase of ≥10 points on the Functional Independence Measure (FIM) or ≥0.5 standard deviations (SD) from baseline; (III) an increase of ≥10 points on the Barthel Index or ≥0.5 SD from baseline.\n\nThe primary objective is to estimate the proportion of responders and non-responders at the end of training or hospitalization. Secondary objectives include identifying variables predictive of treatment response at the end of intervention (training type\u002Fmodality, aetiology, demographic factors, comorbidities), quantifying the dose-response gradient (number of sessions\u002Fsession duration versus response probability), and assessing changes in neurophysiological, physiological, and biological parameters collected during hospitalization (neuroimaging examinations, neurofilament light chain \\[NfL\\] assays, EEG\u002Fevent-related potentials \\[ERP\\], skin conductance response, heart rate frequency and variability, and oculomotor activity).\n\nData will be analysed using descriptive statistics appropriate to variable distributions. The primary endpoint, defined as the proportion of responders at the end of training\u002Fhospitalization, will be evaluated using logistic regression models in an as-treated approach, reporting odds ratios and marginal estimates (risk ratios and absolute risk differences) with 95% confidence intervals (CI). Confounding will be addressed through multivariable adjustment and propensity score-based methods (inverse probability of treatment weighting \\[IPTW\\]\u002Foverlap weighting). Continuous secondary outcomes will be analysed with linear models or linear mixed-effects models for repeated measures. Dose-response relationships will be explored, alongside sensitivity and subgroup analyses. All analyses will be performed using R software (version 4.4.2), employing two-sided tests with a significance level of α=0.05. The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines.",[73],"Disorder of Consciousness",[75,76,77,78,79,80,81,82],"Vegetative state","Minimally conscious state","Neurorehabilitation","Eye-tracking","Neurofilaments","tDCS","multimodal sensory stimulation","Skin conductance response","2026-05-25",{"date":85,"type":86},"2026-05-27","ACTUAL",{"date":88,"type":86},"2026-01-16",{"date":90,"type":68},"2029-01-16",{"name":5,"class":6},1]