[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BCIFlex Medical Technology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100653225","implantable-wireless-brain-computer-interface-systems-in-patients-with-tetraplegia-100653225",false,"NCT07784088","Implantable Wireless Brain-Computer Interface Systems in Patients With Tetraplegia","A Prospective, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of Implantable Wireless Brain-Computer Interface Systems in Patients With Tetraplegia","LEAP","Inclusion Criteria:\n\n* Age ≥18 years and ≤65 years, male or female;\n* Tetraplegia due to C2-C5 cervical spinal cord injury, diagnosed per 2019 revised ISNCSCI of ASIA, injury grade A to B;\n* Intact cognitive function, MoCA-BLIND score ≥19;\n* Elbow flexor muscle strength ≤ Grade 3 by ISNCSCI;\n* Neurological assessment confirms normal motor cortex function without significant organic or functional brain lesions;\n* Tetraplegia diagnosed for ≥12 months, stable clinical status ≥6 months after standard treatment;\n* Good compliance, voluntary participation; informed consent signed by subject or legal representative.\n\nExclusion Criteria:\n\n* Syringomyelia, severe neuralgia or spasticity limiting training participation;\n* Require tracheotomy, mechanical ventilation, nasogastric feeding to sustain vital functions;\n* High surgical risk: active systemic infection, coagulation disorders, antithrombotic therapy users;\n* Subjects implanted with CNS electrical stimulation medical devices;\n* Unstable medical conditions, severe mental\u002Fcognitive disorders confounding endpoint assessment;\n* Severe, unstable, uncontrolled complex regional pain syndrome;\n* Autoimmune-induced spinal cord dysfunction\u002Finjury;\n* History of stroke, multiple sclerosis, drug-resistant epilepsy, Alzheimer's Disease;\n* Peripheral neuropathy;\n* Pregnant\u002Fbreastfeeding females, females planning pregnancy during trial;\n* Require MRI examinations during device implantation period;\n* Participated in other clinical trials within 1 month prior to enrollment;\n* Investigator judges participation unsafe, or subject unlikely to complete protocol follow-up.","ALL","18 Years","65 Years",{"count":21,"type":22},34,"ESTIMATED","INTERVENTIONAL",[25],"NA","Objectives of Study: This trial aims to evaluate the safety and efficacy of an implantable wireless brain-computer interface system in patients with tetraplegia resulting from spinal cord injury.",[28,29,30],"Spinal Cord Injury Cervical","Tetraplegia\u002FTetraparesis","Spinal Cord Injuries (SCI)",[32,33,30],"BCI","Tetraplegia","RECRUITING","2026-08-20",{"date":37,"type":38},"2026-08-25","ACTUAL",{"date":40,"type":38},"2026-07-15",{"date":42,"type":22},"2027-07",{"name":44,"class":45},"BCIFlex Medical Technology Co., Ltd.","INDUSTRY",""]