[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653225":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":11,"studyPopulation":11,"armGroups":47,"interventions":54,"overallOfficials":11,"centralContacts":60,"locations":66,"responsibleParty":84,"collaborators":11,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":11,"studyType":100,"phases":101,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":69,"whyStopped":11,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"BCIFlex Medical Technology Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Success rate of brain-controlled tasks",null,"2, 3, 6 months post-implant",[14,16,19,22,25,27,29,31,34,37],{"measure":15,"description":11,"timeFrame":12},"Digital Instrumental Activities of Daily Living (dIADL)",{"measure":17,"description":18,"timeFrame":12},"Brain Control Fluency Index","The Brain Control Fluency Index is defined as the mean Information Transfer Rate measured by the Web-Grid Task performed by the patients with implantable wireless Brain-Computer Interface System.",{"measure":20,"description":11,"timeFrame":21},"Patient Health Questionnaire-9 (PHQ-9)","Baseline, 2, 3, 6 months post-implant",{"measure":23,"description":11,"timeFrame":24},"Average Monthly Device Usage Duration","6 months post-implant",{"measure":26,"description":11,"timeFrame":21},"WHO Quality of Life BREF",{"measure":28,"description":11,"timeFrame":21},"Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)",{"measure":30,"description":11,"timeFrame":12},"Psychosocial Impact of Assistive Devices Scale (PIADS)",{"measure":32,"description":33,"timeFrame":12},"Subject Satisfaction with the Device","Trial subject report questionnaire to measure the trial subject's satisfaction of using trial device.",{"measure":35,"description":36,"timeFrame":12},"Investigator Satisfaction with Device Operation","Investigator report questionnaire to measure the investigator's satisfaction with device operation.",{"measure":38,"description":39,"timeFrame":40},"Device Reliability","Device Reliability is measure by the Electrode Impedance of the Device","up to 6 months post-implant",{"allocation":42,"interventionModel":43,"interventionModelDescription":11,"primaryPurpose":44,"observationalModel":11,"timePerspective":11,"maskingInfo":45},"NA","SINGLE_GROUP","TREATMENT",{"masking":46,"maskingDescription":11,"whoMasked":11},"NONE",[48],{"label":49,"type":50,"description":51,"interventionNames":52},"Implanted Brain-Computer Interface","EXPERIMENTAL","Device: Implantable wireless brain-computer interface systems",[53],"Device: IWBCIS",[55],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":11},"DEVICE","IWBCIS","Implantable wireless brain-computer interface systems",[49],[61],{"name":62,"role":63,"phone":64,"phoneExt":11,"email":65},"BCIFlex","CONTACT","+86 10 5365 7080","wangxp@bciflex.com",[67],{"facility":68,"status":69,"city":70,"state":11,"zip":11,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Beijing Tiantan Hospital, Capital Medical University","RECRUITING","Beijing","China","CN",{"type":74,"coordinates":75},"Point",[76,77],116.39723,39.9075,{"lat":77,"lon":76},[80],{"name":81,"role":63,"phone":82,"phoneExt":11,"email":83},"Wang Jia, MD","+86 10 5997 6512","jwttyy@126.com",{"type":85,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":98,"type":99},34,"ESTIMATED","INTERVENTIONAL",[42],"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.",[104,105,106],"Spinal Cord Injury Cervical","Tetraplegia\u002FTetraparesis","Spinal Cord Injuries (SCI)",[108,109,106],"BCI","Tetraplegia","2026-08-20",{"date":112,"type":113},"2026-08-25","ACTUAL",{"date":115,"type":113},"2026-07-15",{"date":117,"type":99},"2027-07",{"name":5,"class":6},1]