[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588195":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":57,"collaborators":30,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":30,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":30,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":43,"whyStopped":30,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Qilu Hospital of Shandong University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"VNS activated in late stage","EXPERIMENTAL","Following enrollment, participants with a history of stroke greater than 6 months underwent 1 month of upper-extremity rehabilitation twice per week to rule out potential for recovery with rehabilitation therapy alone. Thereafter, each participant underwent surgical implantation of the VNS system. 1 months later, VNS was activated.",[13],"Device: Vagus Nerve Stimulation in late stage",{"label":15,"type":16,"description":17,"interventionNames":18},"VNS activated in early stage","ACTIVE_COMPARATOR","Following enrollment, participants with a history of stroke within 6 months underwent 1 month of upper-extremity rehabilitation twice per week to rule out potential for recovery with rehabilitation therapy alone. Thereafter, each participant underwent surgical implantation of the VNS system. 1 months later, VNS was activated.",[19],"Device: Vagus Nerve Stimulation in early stage",{"label":21,"type":10,"description":22,"interventionNames":23},"VNS not activated in early stage","Following enrollment, participants with a history of stroke within 6 months underwent 1 month of upper-extremity rehabilitation twice per week to rule out potential for recovery with rehabilitation therapy alone. Thereafter, each participant underwent surgical implantation of the VNS system.When the a history of stroke was exceeded over 6 months, VNS was activated.",[13],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","Vagus Nerve Stimulation in early stage","Device implantation was done under general anaesthesia. A horizontal neck crease incision was created left of the midline at the level of the cricoid cartilage. After the vagus nerve was identified, the stimulation lead was wrapped around the vagus nerve. The lead was then tunnelled subcutaneously to the pulse generator device which was contained in a subcutaneous pocket in the pectoral region.",[15],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Vagus Nerve Stimulation in late stage","Device implantation was done under general anaesthesia. A horizontal neck crease incision was created left of the midline at the level of the cricoid cartilage. After the vagus nerve was identified, the stimulation lead was wrapped around the vagus nerve. The lead was then tunnelled subcutaneously to the pulse generator device which was contained in a subcutaneous pocket in the pectoral region",[9,21],[36],{"name":37,"role":38,"phone":39,"phoneExt":30,"email":40},"Chao Zhang","CONTACT","13969007232","chao_zhang@sdu.edu.cn",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Jinan","Shandong","250100","China","CN",{"type":50,"coordinates":51},"Point",[52,53],116.99722,36.66833,{"lat":53,"lon":52},[56],{"name":37,"role":38,"phone":39,"phoneExt":30,"email":40},{"type":58,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100588195","phase-1-wether-vns-in-early-stage-3-months-is-safe-and-more-beneficial-for-post-stroke-motor-rehabilitation-100588195",false,"NCT06938243","Wether VNS in Early Stage (3 Months) is Safe and More Beneficial for Post-stroke Motor Rehabilitation","The Comparison of Safety and Treatment Results Between Early (\u003C6 Months) and Late (> 6 Months) Vagus Stimulation for Post-stroke Motor Rehabilitation: a Randomized Clinical Trial","Inclusion Criteria:\n\n* Eligible individuals suffered a first-time, unilateral, ischemic stroke in the middle cerebral artery territory that spared the diencephalon and basal ganglia 3-36 months before surgery.\n\n  * Individuals with persistent moderate-to-severe upper-extremity hemiparesis as defined by an FM-UE score of ≤42\n  * Sufficient upper-extremity motor ability to engage in rehabilitation (that is, a score of ≥1 on the FM-UE elbow flexion, elbow extension or finger mass flexion or extension).\n\nExclusion Criteria:\n\n* Excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4) . Severe cognitive impairment (Mini Mental State Examination \\\u003C 24)","ALL","30 Years","75 Years",{"count":70,"type":71},100,"ESTIMATED","INTERVENTIONAL",[74],"PHASE1","Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts. In previous study, Vagus nerve stimulation was constricted to patients 9 months after stroke. In this randomized phase I trial, we would apply vagus nerve stimulation in an early stage (\\\u003C6 month) and observe its theraputic effect on motor function after ischaemic Stroke.We hypothesized that the early stimulation could be safe and more beneficial compared to stimulation in late stage.",[77,78],"Stroke","Motor Rehabilitation",[80,81,82],"Hemiparesis","VNS","Limb Motor Function Rehabilitation","2025-04-14",{"date":85,"type":86},"2025-04-22","ACTUAL",{"date":88,"type":71},"2025-05-01",{"date":90,"type":71},"2026-12-30",{"name":5,"class":6},1]