[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Anna Estraneo\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":120},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,72,98],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100552199","robotic-vs-traditional-verticalization-in-patients-with-severe-acquired-brain-injury-a-randomized-controlled-trial-100552199",false,"NCT06469983","Robotic vs. Traditional Verticalization in Patients With Severe Acquired Brain Injury: a Randomized Controlled Trial","Multicentric Study on Combined Verticalization and Mobilization in Patients With Severe Acquired Brain Injury: A Randomized Controlled Trial","VEM-sABI","Inclusion Criteria:\n\n* Age between 18 and 75 years;\n* sABI due to traumatic, vascular, anoxic, or mixed etiology;\n* Stable behavioral\u002Fcognitive diagnosis on at least 4 behavioral evaluations in 1 week using the Italian version of the CRS-R in patients with pDoC, or the LCF-based cognitive assessment in patients with eDoC;\n* Time post-injury between 28 days and 6 months \\[1\\];\n* Not recovered upright station;\n* Written informed consent by the patient's legal rep-resentative\u002Fprimary caregiver.\n\nExclusion Criteria:\n\n* Severe medical conditions hampering verticalization (e.g., severe hypotension or conditions realizing hemodynamic instability, end stage or severe symptomatic heart failure with reduced ejection fraction, cardiac arrhythmia of new diagnosis or arrhythmic flare, severe hepatic failure, chronic severe lower limb arterio-venous disease, sep-sis\u002Fseptic shock, thrombus venous embolism of new diag-nosis, severe autonomic dysreflexia);\n* Severe medical conditions hampering lower limb mobili-zation (e.g., fractures, heterotopic ossifications);\n* Severe medical conditions impacting EEG activity (e.g., sub-continuous or abundant EEG epileptiform abnormali-ties);\n* Severe medical conditions influencing conscious-ness\u002Fcognitive status, such as severe hyponatremia or hy-poglycemia;\n* Contraindications to the use of Erigo®Basic and\u002For Eri-go®Pro (Hocoma, Volketswil, Switzerland) as per technical data sheet (see Appendix A);\n* Presence of prohibited drugs","ALL","18 Years","75 Years",{"count":21,"type":22},118,"ESTIMATED","INTERVENTIONAL",[25],"NA","In the rehabilitation project for patients with severe Acquired Brain Injury (sABI), it is essential to include exercises that facilitate the recovery of the upright position (or verticalization). Recently, tilt-table equipped with the robot-assisted lower limbs cyclic mobilization has been proposed as a safe and suitable device for accelerating the adaptation to vertical posture in bedridden patients with brain-injury since the acute phase. The present multicentre study aims at evaluating the effectiveness of robotic assisted verticalization plus mobilization (VEM) versus traditional verticalization (TV) in a large cohort of patients with sABI.",[28,29],"Acquired Brain Injury","Disorder of Consciousness",[31,32,33,34],"Disorders of Consciousness","rehabilitation","verticalization","robotic","RECRUITING","2025-11-17",{"date":38,"type":39},"2025-11-20","ACTUAL",{"date":41,"type":39},"2024-12-02",{"date":43,"type":22},"2026-11-30",{"name":45,"class":46},"Anna Estraneo","OTHER",6,{"id":49,"slug":4,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":70,"locationsCount":71},"100552575","NCT06474871","Virtual Reality vs Traditional Cognitive Training in Patients With Severe Acquired Brain Injury","Multicentric Study on Implementation of Virtual Reality for Rehabilitation of Cognitive Functions in Patients With Severe Acquired Brain Injury: a Randomized Controlled Trial","VR-sABI","Inclusion Criteria:\n\n* LCF ≥4 at study entry;\n* Age 18-75\n* Stable clinical diagnosis (i.e., stable LCF);\n* Time post-injury between 28 days and 6 months;\n* Ability to complete the pre-test A section of the Italian version of the Trail Making Test (TMT);\n* A pathological B-A score of the TMT according to normative data adjusted for age and education;\n* Signed informed consent by the patient or by the patient's primary caregiver.\n\nExclusion Criteria:\n\n* Severe medical conditions that might hamper participation in the rehabilitation sessions, or influence diagnosis;\n* Previous neurodegenerative or acquired neurological diseases that affect cognitive domains (e.g., dementia)",{"count":56,"type":22},28,[25],"Considerable evidence exists for using Virtual Reality (VR) for rehabilitation of acquired brain injury (ABI), with a particular focus on stroke. However, to date very little evidence has been collected in patients with ABI with different aetiologies (i.e., traumatic or anoxic brain injury) and level of severity (i.e., severe, sABI). The present multicentre study aims to overcome current literature issues as heterogeneity of populations and outcomes, small sample sizes and a lack of randomized controlled trials, which can affect the level of evidence and generalizability of results, to determine the effectiveness of a non immersive VR-based rehabilitation versus traditional cognitive training (TCT).",[28],[61,32,62,63],"severe acquired brain injury","virtual reality","executive functions","2025-09-24",{"date":66,"type":39},"2025-09-29",{"date":68,"type":39},"2024-10-28",{"date":43,"type":22},{"name":45,"class":46},3,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100586959","tickle-stimulation-in-disorders-of-consciousness-doc-100586959","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.",{"count":81,"type":22},45,"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.",[31],[86,87,88,31],"Tickle stimulation","Behavioural evaluation","Neurophysiological evaluation","2025-04-17",{"date":91,"type":39},"2025-04-23",{"date":93,"type":39},"2023-06-30",{"date":95,"type":22},"2025-10-31",{"name":45,"class":46},2,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":108,"conditions":109,"keywords":110,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":4},"100586956","tactile-stimulation-in-disorders-of-consciousness-doc-100586956","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.",{"count":107,"type":22},30,"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.",[31],[111,31,87,88,112],"Tactile stimulation","Pleasant touch stimulation","NOT_YET_RECRUITING",{"date":91,"type":39},{"date":116,"type":22},"2025-04",{"date":118,"type":22},"2025-10",{"name":45,"class":46},""]