[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642955":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":44,"collaborators":11,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":11,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":11,"overallStatus":65,"whyStopped":11,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"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,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Huashan Hospital, Fudan University","Shanghai","Shanghai Municipality","China","CN",{"type":34,"coordinates":35},"Point",[36,37],121.45806,31.22222,{"lat":37,"lon":36},[40],{"name":41,"role":23,"phone":42,"phoneExt":11,"email":43},"Ying Mao, Ph.D","+86 021 5288 8045","maoying@fudan.edu.cn",{"type":45,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100642955","wireless-implantable-mandarin-chinese-speech-neuroprosthesis-evaluation-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":57,"type":58},4,"ESTIMATED","INTERVENTIONAL",[61],"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.",[64],"Speech Disorder","NOT_YET_RECRUITING","2026-06-09",{"date":68,"type":69},"2026-06-15","ACTUAL",{"date":71,"type":58},"2026-06-30",{"date":73,"type":58},"2028-12-30",{"name":5,"class":6},1]