[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584686":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":26,"responsibleParty":40,"collaborators":43,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":26,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":26,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":70,"overallStatus":76,"whyStopped":26,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":26},{"fullName":5,"class":6},"First Affiliated Hospital of Fujian Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"VNS group","EXPERIMENTAL","Active VNS paired with rehabilitation Device: VNS A neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve.\n\nOther: Rehabilitation Rehabilitation movements to improve upper limb function after stroke.",[13],"Device: Active-VNS",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","SHAM_COMPARATOR","Sham VNS paired with rehabilitation Device: Sham VNS A neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve, the actual intensity is 0 mA.\n\nOther: Rehabilitation Rehabilitation movements to improve upper limb function after stroke.",[19],"Device: Sham VNS",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Active-VNS","A neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham VNS","A neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve, the actual intensity is 0 mA.",[15],[32],{"name":33,"affiliation":5,"role":34},"Fuxin Lin","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","13600893154","lfxstudy@126.com",{"type":34,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"De-zhi Kang","Prof.",[44],{"name":45,"class":46},"Beijing Pins Medical Co., Ltd","INDUSTRY","100584686","rehabilitation-paired-with-vns-for-motor-function-recovery-100584686",false,"NCT06892574","Rehabilitation Paired with VNS for Motor Function Recovery","A Trial of Rehabilitation Paired with VNS for Motor Function Recovery in Post-ICH Patients (Recovery Study)","Inclusion Criteria:\n\n* Age ≥22 years and \\\u003C80 years, all gender is acceptable.\n* History of unilateral supratentorial intracerebral hemorrhage ≥ 6 months but \\\u003C 5 years.\n* Upper Extremity motor section of the Fugl-Meyer Assessment score ≥20 and ≤50.\n* Right- or left-sided weakness of upper extremity.\n* Ability to communicate, understand, and give appropriate consent. Subjects can follow trial commands.\n* Subjects have good compliance and can complete the visits after surgery.\n\nExclusion Criteria:\n\n* History of ischemic stroke.\n* Cerebral hemorrhage resulting from tumors, trauma, aneurysms, or hemorrhagic transformation of ischemic stroke.\n* Presence of ongoing dysphagia or aspiration difficulties.\n* Prior injury to vagus nerve, either bilateral or unilateral.\n* Subject receiving medication that may significantly interfere with actions of VNS on neurotransmitter systems at study entry, clinic rehabilitation follow-up timepoint, or home rehabilitation follow-up timepoint, such as centrally acting cholinoceptor blockers, centrally acting adrenoceptor blockers, norepinephrine re-uptake inhibitors, etc.\n* Botox injections within 4 weeks prior to enrollment through the unmasking follow-up timepoint (Visit 6).\n* Severe spasticity of the upper extremity (Modified Ashworth ≥ 3).\n* Significant sensory loss of the upper extremity (Upper Extremity sensory section of the Fugl-Meyer Assessment score \\\u003C 6).\n* Current requirement, or likely future requirement, of diathermy.\n* Current use of any other stimulation device, such as a pacemaker or other neurostimulator.\n* Pregnancy or plans to become pregnant or to breastfeed during the study period.\n* Participated in any other clinical trials within the preceding 3 months.\n* Not considered to be applicable by the investigator.","ALL","22 Years","79 Years",{"count":58,"type":59},10,"ESTIMATED","INTERVENTIONAL",[62],"NA","The goal of this clinical trial is to investigate the efficacy and safety of vagus nerve stimulation (VNS) combined with rehabilitation in improving upper extremity motor function after spontaneous intracerebral hemorrhage (ICH).\n\nResearchers will evaluate the efficacy and safety of VNS by comparing the improvements of arm motor function post-ICH in the active VNS combined rehabilitation group with that in the sham VNS combined rehabilitation group (actual intensity 0 mA).\n\nParticipants in this study will undergo a surgical procedure to implant the VNS system and will subsequently recieve a 6 weeks in-clinic therapy, followed by an additional 6 weeks home exercise. During the final 6 weeks, participants will either recieve in-clinic therapy or maintain their home exercise, depending on their assigned group.",[65,66,67,68,69],"Spontaneous Intracerebral Hemorrhage","Motor Function","Upper Extremity Injury","Rehabilitation","Vagus Nerve Stimulation",[71,72,73,69,74,75,68],"Stroke","Hemorrhagic Stroke","Upper Extremity Paresis","Neuromodulation","Randomized Controlled Trial","NOT_YET_RECRUITING","2025-03-23",{"date":79,"type":80},"2025-03-26","ACTUAL",{"date":82,"type":59},"2025-04-01",{"date":84,"type":59},"2027-12-30",{"name":5,"class":6}]