[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601083":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":47,"centralContacts":51,"locations":60,"responsibleParty":77,"collaborators":25,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":25,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":25,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":62,"whyStopped":25,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Epidural Electrical Stimulation (EES) + Standard Rehabilitation","EXPERIMENTAL","Participants receive the EES intervention combined with standard rehabilitation therapy (e.g., physical therapy, occupational therapy) for 6 months.",[13,14,15,16,17,18],"Procedure: Epidural Electrical Stimulation","Procedure: Standard Rehabilitation Therapy","Radiation: positron emission tomography-computed tomography (PET-CT)","Radiation: Diffusion Tensor Imaging (DTI)","Procedure: Somatosensory Evoked Potentials (SEPs)","Procedure: Motor Evoked Potentials (MEPs)",[20,26,30,35,39,43],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Epidural Electrical Stimulation","Epidural Electrical Stimulation (EES) is a medical technology that involves delivering controlled electrical impulses to the spinal cord through electrodes implanted in the epidural space-the area between the outermost membrane of the spinal cord (dura mater) and the vertebrae. This technique aims to modulate the activity of spinal neural networks, thereby regulating neurological functions and promoting functional recovery, particularly in individuals with spinal cord injuries or certain neurological disorders.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard Rehabilitation Therapy","A structured, multidisciplinary rehabilitation program designed to improve motor function, mobility, and independence in participants with paralysis. The therapy typically includes physical Therapy and occupational Therapy.",[9],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":25},"RADIATION","positron emission tomography-computed tomography (PET-CT)","PET-CT is an advanced hybrid imaging modality that combines metabolic information from positron emission tomography with anatomical details from computed tomography.",[9],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":25},"Diffusion Tensor Imaging (DTI)","DTI is an advanced MRI technique that maps white matter tracts by measuring the directionality (anisotropy) and magnitude of water molecule diffusion in neural tissues. It provides quantitative metrics of fibers.",[9],{"type":21,"name":40,"description":41,"armGroupLabels":42,"otherNames":25},"Somatosensory Evoked Potentials (SEPs)","SEPs are electrophysiological responses recorded from the central or peripheral nervous system following electrical stimulation of sensory nerves. They assess the functional integrity of somatosensory pathways.",[9],{"type":21,"name":44,"description":45,"armGroupLabels":46,"otherNames":25},"Motor Evoked Potentials (MEPs)","MEPs are electrophysiological responses elicited by transcranial magnetic stimulation or electrical stimulation of the motor cortex, recorded from peripheral muscles or the spinal cord. They evaluate the integrity of corticospinal tracts.",[9],[48],{"name":49,"affiliation":5,"role":50},"Junming Zhu, Chief Physician","PRINCIPAL_INVESTIGATOR",[52,56],{"name":49,"role":53,"phone":54,"phoneExt":25,"email":55},"CONTACT","13968055768","dr.zhujunming@zju.edu.cn",{"name":57,"role":53,"phone":58,"phoneExt":25,"email":59},"Zhoule Zhu, Attending Physician","15168377035","doczhuzl@zju.edu.cn",[61],{"facility":5,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"RECRUITING","Hangzhou","Zhejiang","310009","China","CN",{"type":69,"coordinates":70},"Point",[71,72],120.16142,30.29365,{"lat":72,"lon":71},[75,76],{"name":49,"role":53,"phone":54,"phoneExt":25,"email":55},{"name":57,"role":53,"phone":58,"phoneExt":25,"email":59},{"type":50,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Junming Zhu","Chief Physician","100601083","epidural-electrical-stimulation-in-spinal-cord-injury-100601083",false,"NCT07105878","Epidural Electrical Stimulation in Spinal Cord Injury","Epidural Electrical Stimulation for Motor and Sensory Function Reconstruction in Spinal Cord Injury","Inclusion Criteria:\n\n* Spinal Cord Injury, ASIA B-D;\n* Spinal cord injury level above T10;\n* Diagnosed with spinal cord injury for ≥ 8 months and ≤ 36 months;\n* WISCI II score \\\u003C 13;\n* No significant improvement in motor dysfunction after rehabitation over the past 2 months.\n* An expected survival period of ≥ 12 months.\n* Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, cooperate with necessary postoperative rehabilitation training and tests, and assist in follow-up visits.\n\nExclusion Criteria:\n\n* Subjects with other severe organic neurological diseases, mental illnesses other than anxiety\u002Fdepression.\n* Subjects with hemorrhagic diathesis or coagulation dysfunction (prothrombin time \\[PT\\] ≥ 18 seconds).\n* Subjects with a history of alcohol or drug abuse or dependence.\n* Subjects with mental retardation, cognitive dysfunction, or personality disorders.\n* Subjects with a history of electroconvulsive therapy or those requiring continuous electrotherapy.\n* Subjects with implanted cardiac pacemakers, cardioverters, or defibrillators. Expected survival period \\\u003C 1 year.","ALL","16 Years","60 Years",{"count":91,"type":92},10,"ESTIMATED","INTERVENTIONAL",[95],"NA","The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) in motor and sensory function Reconstruction in chronic spinal cord injury (SCI) patients classified as ASIA B-D. The main questions it aims to answer are:\n\nDoes EES treatment significantly improve motor and sensory function in patients with SCI compared to baseline? Is EES a safe intervention for this patient population? Researchers will compare participants' motor function, sensory function, and quality of life assessments before EES implantation, immediately after activation of the device, and at 1, 3, and 6 months post-implantation to evaluate the longitudinal effects of EES.\n\nParticipants will:\n\nUndergo surgical implantation of an EES device in the epidural space. Have the EES device activated and receive personalized stimulation parameter adjustments during follow-up visits.\n\nComplete regular motor and sensory function assessments using standardized protocols.\n\nParticipate in structured rehabilitation training sessions while using the EES device.\n\nReport any adverse events and complete quality of life questionnaires at specified follow-up intervals.",[98],"Spinal Cord Injuries (SCI)",[22,100,101,102],"Spinal Cord Injuries","Sensor function reconstruction","Motor function reconstruction","2026-04-21",{"date":105,"type":106},"2026-04-24","ACTUAL",{"date":108,"type":106},"2025-03-01",{"date":110,"type":92},"2026-12-31",{"name":5,"class":6},1]