[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586959":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":37,"locations":43,"responsibleParty":69,"collaborators":10,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":10,"enrollmentInfo":83,"targetDuration":10,"studyType":86,"phases":10,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":58,"whyStopped":10,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"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: Tickle stimulation","Device: Neurophysiological Monitoring with SedLine",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"BEHAVIORAL","Tickle stimulation","Patients will be subjected to tickling:\n\nthey will be tickled bilaterally in three areas, the soles of the feet, the armpits, and the ribs-plus a control area, the forehead. The stimulation will be manual and performed by rubbing the targeted body part while opening and closing the fingers in pairs in an arched motion. Additionally, patients will also undergo a neutral stimulation (in the same body areas), which consists of simply touching the area without inducing tickling.",[9],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Neurophysiological Monitoring with SedLine","SedLine is a portable, non-invasive EEG monitoring device used to record electrical brain activity through frontal electrodes. In the TICKLING-DOC study, SedLine is used to assess cortical responses in patients with disorders of consciousness (DoC) during manual tactile stimulation, specifically tickling, and neutral touch. The EEG data are recorded before, during, and after stimulation to detect neural reactivity and possible correlations with behavioral responses. The goal is to investigate whether tickle-evoked EEG activity reflects residual consciousness and contributes to diagnostic and rehabilitative strategies. SedLine allows continuous monitoring in a bedside setting, offering safe, real-time assessment of brain function.",[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],{"name":39,"role":40,"phone":41,"phoneExt":10,"email":42},"Simona Abagnale, PhD","CONTACT","+393487520258","sabagnale@dongnocchi.it",[44,57],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":48,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":10},"Coma Science Group - University of Liege","COMPLETED","Liège","Belgium","4000","BE",{"type":52,"coordinates":53},"Point",[54,55],5.56749,50.63373,{"lat":55,"lon":54},{"facility":32,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":68,"contacts":10},"RECRUITING","Sant'Angelo dei Lombardi","Avellino","83054","Italy","IT",{"type":52,"coordinates":65},[66,67],15.17535,40.92937,{"lat":67,"lon":66},{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Anna Estraneo","MD Neurologist Senior researcher","100586959","tickle-stimulation-in-disorders-of-consciousness-doc-100586959",false,"NCT06922162","Tickle Stimulation in Disorders of Consciousness (DoC)","Behavioural and Physiological Responses to Tickling in Patients With Disorders of Consciousness","TICKLING-DOC","Inclusion Criteria:\n\n* Diagnosis of disorders of consciousness (DoC) based on the CRS-R scale;\n* Age ≥18 years;\n* Time since the event ≥ 28 days\n\nExclusion Criteria:\n\n* Large craniectomy that may interfere with fNIRS recording; Unstable clinical conditions (e.g., respiratory failure, fever, status epilepticus, etc.);\n* Fractures, paralysis, injuries, or muscular dystrophy that prevent proper stimulation of the aforementioned body parts;\n* Lack of informed consent from the legal representative.","ALL","18 Years",{"count":84,"type":85},45,"ESTIMATED","OBSERVATIONAL","The aim of this project is to investigate whether tickling stimulations can have a short-term effect on the responsiveness of patients with Disorders of Consciousness due to Severe Acquired Brain Injury and to compare this effect with that of neutral tactile stimulations that do not induce tickling.",[89],"Disorders of Consciousness",[18,91,92,89],"Behavioural evaluation","Neurophysiological evaluation","2025-04-17",{"date":95,"type":96},"2025-04-23","ACTUAL",{"date":98,"type":96},"2023-06-30",{"date":100,"type":85},"2025-10-31",{"name":71,"class":6},2]