[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612500":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":11,"centralContacts":46,"locations":52,"responsibleParty":73,"collaborators":11,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":11,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":11,"enrollmentInfo":84,"targetDuration":11,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":55,"whyStopped":11,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Istituti Clinici Scientifici Maugeri SpA","OTHER",[8,15,21,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Khymeia + Sham tVNS","SHAM_COMPARATOR",null,[13,14],"Device: Sham tVNS","Device: Khymeia robotic upper limb rehabilitation",{"label":16,"type":17,"description":11,"interventionNames":18},"Traditional Rehabilitation + Active tVNS","EXPERIMENTAL",[19,20],"Device: Active trans-auricular vagus nerve stimulation (tVNS)","Behavioral: Traditional Rehabilitation",{"label":22,"type":10,"description":11,"interventionNames":23},"Traditional Rehabilitation + Sham tVNS",[13,20],{"label":25,"type":17,"description":11,"interventionNames":26},"Khymeia + Active tVNS",[19,14],[28,33,37,41],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"DEVICE","Active trans-auricular vagus nerve stimulation (tVNS)","Active tVNS with the Parasym® device (CE 0197). Electrode placed on the left tragus, 25 Hz, 250 μs, intensity to tolerance, 60 min\u002Fday, 5 days\u002Fweek for 4 weeks.",[25,16],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"Sham tVNS","Sham tVNS using the Parasym® device with electrodes on the left earlobe (non-vagal area). Same schedule as active tVNS (60 min\u002Fday, 5 days\u002Fweek for 4 weeks).",[9,22],{"type":29,"name":38,"description":39,"armGroupLabels":40,"otherNames":11},"Khymeia robotic upper limb rehabilitation","Robotic-assisted rehabilitation for the upper limbs using the Khymeia system.",[25,9],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":11},"BEHAVIORAL","Traditional Rehabilitation","Standard traditional physical therapy and rehabilitation protocols for upper limb recovery.",[16,22],[47],{"name":48,"role":49,"phone":50,"phoneExt":11,"email":51},"Cira Fundaro'","CONTACT","0385247268","cira.fundaro@icsmaugeri.it",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"ICS Maugeri - Montescano","RECRUITING","Montescano","Pavia","27040","Italy","IT",{"type":62,"coordinates":63},"Point",[64,65],9.28366,45.03196,{"lat":65,"lon":64},[68,70],{"name":69,"role":49,"phone":50,"phoneExt":11,"email":51},"Cira Fundarò, MD",{"name":71,"role":72,"phone":11,"phoneExt":11,"email":11},"Weizhi Chen","SUB_INVESTIGATOR",{"type":74,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100612500","effects-of-trans-auricular-vagal-stimulation-on-neuromotor-recovery-in-subacute-stroke-during-technological-and-traditional-training-100612500",false,"NCT07254390","Effects of Trans-Auricular Vagal Stimulation on Neuromotor Recovery in Subacute Stroke During Technological and Traditional Training","Effects of Trans-Auricular Vagal Stimulation on Neuromotor Recovery Post-Stroke in the Subacute Phase During Training With the Khymeia Technological Device and Traditional Rehabilitation","Inclusion Criteria:\n\n* Patients with hemiplegia following ischemic or hemorrhagic stroke occurred within the previous 6 months, clinically stable\n* Age ≥ 18 years\n* Single cortical or subcortical lesion documented on neuroimaging, corresponding to the motor deficit\n* Cognitively able to understand and follow therapeutic instructions\n* Upper limb weakness confirmed by a Motricity Index score below maximum\n* Spasticity, if present, compatible with limb function (Modified Ashworth Scale ≤ 2)\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Multiple brain lesions on neuroimaging\n* Severe spasticity (Modified Ashworth Scale 3-4)\n* Aphasia preventing comprehension of verbal instructions\n* Cognitive decline or behavioral disorders interfering with collaboration during training\n* Orthopedic conditions or surgical outcomes preventing the execution of the rehabilitation training","ALL","18 Years",{"count":85,"type":86},48,"ESTIMATED","INTERVENTIONAL",[89],"NA","This randomized pilot clinical study aims to investigate the effects of trans-auricular vagus nerve stimulation (tVNS) on neuromotor recovery in patients in the subacute phase after stroke. Participants admitted for intensive rehabilitation at ICS Maugeri Centers (Montescano, Pavia, Nervi) will be randomized into four groups receiving either traditional or technological rehabilitation (Khymeia device), combined with active or sham tVNS.\n\nThe Parasym® device (CE 0197) delivers non-invasive stimulation of the auricular branch of the vagus nerve at the left ear for 60 minutes daily.\n\nThe primary outcome is the improvement in upper limb motor function, assessed by the Fugl-Meyer scale. Secondary outcomes include other clinical, cognitive, and psychological measures, as well as neurophysiological and cardiovascular autonomic parameters.\n\nThe study hypothesizes that coupling tVNS with rehabilitation enhances cortical plasticity and accelerates motor recovery. Adverse effects are expected to be minimal, with previous studies reporting only mild transient skin irritation. The results may provide new insights into the neurophysiological mechanisms of recovery and support the integration of non-invasive neuromodulation in post-stroke rehabilitation.",[92],"Stroke",[94,95,96,97,98],"Transcutaneous vagus nerve stimulation (tVNS)","Stroke rehabilitation","Neuroplasticity","Upper limb motor recovery","Non-invasive neuromodulation","2026-05-07",{"date":101,"type":102},"2026-05-12","ACTUAL",{"date":104,"type":102},"2025-01-08",{"date":106,"type":86},"2027-04-03",{"name":5,"class":6},1]