[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642955":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":43,"collaborators":11,"id":45,"slug":11,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":11,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":11,"overallStatus":63,"whyStopped":11,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"Shanghai StairMed Technology Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Implantation of the WRS","EXPERIMENTAL",null,[13],"Device: WRS",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","WRS","WRS is a minimally invasive, wireless brain-machine interface system. Subjects with speech disorders undergo implantation of WRS, receive brain-control training, and are followed up.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Clinical team Stairmed","CONTACT","+86 021-80510178","yumiao@stairmed.com",[27],{"facility":28,"status":11,"city":29,"state":30,"zip":11,"country":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Huashan Hospital, Fudan University","Shanghai","Shanghai Municipality","China",{"type":33,"coordinates":34},"Point",[35,36],121.45806,31.22222,{"lat":36,"lon":35},[39],{"name":40,"role":23,"phone":41,"phoneExt":11,"email":42},"Ying Mao, Ph.D","+86 021 5288 8045","maoying@fudan.edu.cn",{"type":44,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100642955",false,"NCT07647315","Wireless Implantable Mandarin Chinese Speech Neuroprosthesis Evaluation","WISE","Inclusion Criteria:\n\n* Age 18 to 80 years (inclusive), any gender.\n* Clinically diagnosed with speech disorders, including locked-in syndrome, severe dysarthria, aphasia with preserved auditory comprehension, or late-stage ALS-related language dysfunction, secondary to stroke, traumatic brain injury, amyotrophic lateral sclerosis (ALS), or other motor neuron diseases.\n* The subject, or the subject with the assistance of their legal representative, is willing to follow the investigator's instructions, adhere to all protocol-specified procedures, and complete all required follow-up.\n* The subject and their legal representative fully understand the purpose and significance of the trial; the subject voluntarily agrees to participate and signs the informed consent form\n\nExclusion Criteria:\n\n* Subjects with any previously implanted metallic objects or devices (e.g., pacemakers, defibrillators, neurostimulators, cochlear implants), except for dental metal implants or implants assessed to have no impact on the trial.\n* Subjects who have been on long-term anticoagulant or antiplatelet therapy prior to screening, with antiplatelet drugs discontinued for less than 2 weeks before surgery; or subjects with hematological or autoimmune disorders (e.g., aplastic anemia, systemic lupus erythematosus); or subjects with clinically significant coagulation test abnormalities during the screening period.\n* Subjects assessed by an anesthesiologist to be unable to tolerate anesthesia and surgery.\n* Subjects assessed by the investigator to have nervous system diseases (e.g., cerebrovascular lesions, intracranial infections, neurodegenerative diseases, epilepsy) or a history of craniocerebral trauma, resulting in severe brain function impairment or marked EEG abnormalities.\n* Subjects with physiological or pathological conditions that may lead to poor healing of scalp wounds.\n* Subjects in the acute infection phase or suffering from other severe infections.\n* Subjects with cognitive impairment or psychotic symptoms.\n* Subjects with severe dysfunction of vital organs (heart, lung, liver, kidney, etc.), malignant tumors or autoimmune diseases, who are deemed ineligible for this clinical trial by investigators.\n* Subjects judged by investigators to have an expected survival time of less than 1 year.\n* Subjects with drug abuse or alcohol dependence.\n* Pregnant or breastfeeding women, or subjects planning to become pregnant during the trial period.\n* Subjects currently participating in clinical trials of drugs or other medical devices.\n* Subjects unable to understand or read Chinese.\n* Other circumstances under which investigators consider the subject unsuitable to participate in this clinical trial","ALL","18 Years","80 Years",{"count":55,"type":56},4,"ESTIMATED","INTERVENTIONAL",[59],"NA","This prospective, single-arm clinical trial is designed to preliminarily evaluate the safety and efficacy of an implantable wireless brain-computer interface (BCI) system (manufactured by Shanghai StairMed Technology Co., Ltd.) in enabling subjects with speech disorders to achieve brain-controlled interaction and communication. Eligible subjects will undergo surgical implantation of the device and receive brain-control training. All participants will be followed for an expected period of 12 months. During the follow-up, adverse events, serious adverse events, and device deficiencies will be recorded, and efficacy data on brain-controlled interaction and communication will be collected. The goal is to conduct an initial assessment of the safety and effectiveness of the investigational device in achieving brain-controlled effects in the target population.",[62],"Speech Disorder","NOT_YET_RECRUITING","2026-06-09",{"date":66,"type":67},"2026-06-15","ACTUAL",{"date":69,"type":56},"2026-06-30",{"date":71,"type":56},"2028-12-30",{"name":5,"class":6},1]