[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586956":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":37,"locations":10,"responsibleParty":46,"collaborators":50,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":10,"enrollmentInfo":62,"targetDuration":10,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":73,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":10},{"fullName":5,"class":6},"Fondazione Don Carlo Gnocchi Onlus","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with Disorders of Consciousness (DoC)",null,"All patients with disorders of consciousness who are consecutively admitted to the participating centers of the study will be enrolled with a diagnosis of disorders of consciousness based on the CRS-R scale, with an age ≥18 years and a time since the event ≥ 28 days.",[13,14],"Behavioral: Tactile stimulation","Device: Neurophysiological Monitoring with SedLine",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"BEHAVIORAL","Tactile stimulation","Patients will undergo a resting-state EEG and fNIRS recording, followed by the administration of the SECONDs scale. Tactile stimulation will then be performed on eight areas of the body (internal and external forearms, palms and backs of the hands on both sides) using six different stimuli categorized as pleasant, neutral, or unpleasant. Stimuli will be applied manually in randomized blocks. EEG and fNIRS data will be recorded before, during, and after stimulation. Behavioural responses will be evaluated through video analysis by independent raters. The session will last approximately 90 minutes.",[9],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Neurophysiological Monitoring with SedLine","SedLine is a non-invasive neurophysiological monitoring device used to record the brain's electrical activity (EEG) through frontal electrodes. In this study, SedLine is employed to measure resting-state and stimulus-evoked cortical responses in patients with disorders of consciousness (DoC), in combination with functional near-infrared spectroscopy (fNIRS). The EEG signals are used to assess changes in neural activity before, during, and after tactile stimulation with various affective valences (pleasant, neutral, unpleasant). This combined multimodal approach enhances the understanding of sensory processing and cortical reactivity in patients with impaired consciousness.",[9],[27,28],"SedLine EEG Monitor","Masimo SedLine",[30,34],{"name":31,"affiliation":32,"role":33},"Anna Estraneo, MD","Fondazione Don Gnocchi","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":36,"role":33},"Olivia Gosseries, PhD, Professor","University of Liege",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":10,"email":42},"Simona Simona Abagnale, PhD","CONTACT","+39 3487520258","sabagnale@dongnocchi.it",{"name":44,"role":40,"phone":10,"phoneExt":10,"email":45},"Anna Estraneo, MD Study Principal Investigat","aestraneo@dongnocchi.it",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Anna Estraneo","MD Neurologist Senior researcher",[51],{"name":36,"class":6},"100586956","tactile-stimulation-in-disorders-of-consciousness-doc-100586956",false,"NCT06922123","Tactile Stimulation in Disorders of Consciousness (DoC)","Behavioural and Neurophysiological Reactions During Tactile Stimulation in Patients Suffering From Disorders of Consciousness (DoC)","TACTILE-DOC","Inclusion Criteria:\n\n* Clinical diagnosis of a disorder of consciousness (DoC), as determined by repeated Coma Recovery Scale-Revised (CRS-R) assessments;\n* Age ≥ 18 years;\n* Time since acute event ≥ 28 days.\n* Written informed consent obtained from the legal representative\n\nExclusion Criteria:\n\n* Presence of large craniectomy that may interfere with fNIRS signal acquisition;\n* Unstable clinical conditions (e.g., respiratory insufficiency, fever, status epilepticus);\n* Fractures, paralysis, lesions, or muscular atrophy that prevent proper tactile stimulation of the specified body areas;\n* Absence of informed consent from the legal representative.","ALL","18 Years",{"count":63,"type":64},30,"ESTIMATED","OBSERVATIONAL","The aim of this project is to evaluate the behavioural and neurophysiological responses to pleasant touch in patients with disorders of consciousness (DoC) and to determine whether these responses are related to the level of consciousness. Specifically, the study aims to:\n\n1. explore the relationship between pleasant tactile stimulation and behavioural and neurophysiological responses in patients with DoC;\n2. determine whether behavioural responses to pleasant touch stimulation correlate with the level of consciousness;\n3. assess whether behavioural responses vary depending on the valence of the stimulus (pleasant, neutral, or unpleasant);\n4. examine neurophysiological responses to tactile stimulation using functional near-infrared spectroscopy (fNIRS), and evaluate whether brain activation patterns are associated with behavioural responses;\n5. improve diagnostic accuracy in patients with DoC by exploring the value of somatosensory responses in distinguishing unresponsive wakefulness syndrome (UWS) from minimally conscious state (MCS) or conscious patients;\n6. explore the potential usefulness of implementing this type of stimulation within rehabilitation programs to support better recovery of consciousness.",[68],"Disorders of Consciousness",[18,68,70,71,72],"Behavioural evaluation","Neurophysiological evaluation","Pleasant touch stimulation","NOT_YET_RECRUITING","2025-04-17",{"date":76,"type":77},"2025-04-23","ACTUAL",{"date":79,"type":64},"2025-04",{"date":81,"type":64},"2025-10",{"name":48,"class":6}]