[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai StairMed Technology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":110},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,63,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"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":5,"type":20},"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Speech Disorder","NOT_YET_RECRUITING","2026-06-09",{"date":30,"type":31},"2026-06-15","ACTUAL",{"date":33,"type":20},"2026-06-30",{"date":35,"type":20},"2028-12-30",{"name":37,"class":38},"Shanghai StairMed Technology Co., Ltd.","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":39},"100639160","implantable-wireless-brain-machine-interface-system-for-spinal-cord-injury-efficacy-and-safety-study-100639160","NCT07603752","Implantable Wireless Brain-Machine Interface System for Spinal Cord Injury: Efficacy and Safety Study","A Prospective, Open-label, Multi-center, Single-arm Study to Evaluate the Efficacy and Safety of an Implantable Wireless Brain-machine Interface System in Patients With Spinal Cord Injury","Inclusion Criteria:\n\n1. Aged 18 to 65 years old (inclusive), with no restriction on gender.\n2. Meeting all the following requirements:\n\n(1) Suffering from complete or incomplete tetraplegia secondary to cervical spinal cord injury (C2-C6); (2) Diagnosed in line with the 2019 revised International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) issued by the American Spinal Injury Association (ASIA), with neurological injury grade classified as Grade A to Grade C; (3) Having fulfilled the above diagnostic criteria for no less than 12 months; 3. Confirmed by imaging examinations and neurological evaluations that the motor-related cerebral cortex is structurally intact, functionally normal and free of obvious atrophy, organic lesions or functional disorders; 4. Fertile participants must agree to use effective contraception throughout the trial period; 5. Participants, either independently or with caregiver assistance, are willing to follow investigators' guidance, comply with all procedures stipulated in the study protocol and complete all scheduled trial visits as required; 6. Having normal cognitive function with a Mini-Mental State Examination (MMSE) score ≥20 points (excluding three-step commands, writing and drawing items); 7. Elbow flexor muscle strength ≤ Grade 3 assessed by ISNCSCI scale; 8. Being of good compliance, voluntarily participating in the clinical trial and signing the informed consent form.\n\nExclusion Criteria:\n\n1. Having received implantation of any metallic objects or devices in the body (e.g., pacemaker, defibrillator, neurostimulator, cochlear implant, electronic devices, drug infusion pumps, etc.), excluding dental metallic implants or other implants confirmed to have no impact on the study.\n2. Long-term use of anticoagulants or antiplatelet drugs prior to screening, with antiplatelet drugs not discontinued for at least 2 weeks before surgery; or suffering from hematological diseases such as aplastic anemia and systemic lupus erythematosus; or having clinically significant abnormal coagulation function during the screening period.\n3. Having contraindications to magnetic resonance imaging (MRI) or being unable to complete MRI examinations for other reasons.\n4. Being assessed by anesthesiologists as intolerant to anesthetic surgery.\n5. Having neurological diseases (e.g., cerebrovascular lesions, intracranial infection, neurodegenerative diseases, epilepsy) or a history of craniocerebral trauma leading to severe brain dysfunction or obvious abnormal electroencephalographic signals, as judged by investigators.\n6. Suffering from physical or pathological conditions that may cause failed normal healing of scalp wounds.\n7. Being in the stage of acute infection or suffering from other severe infections.\n8. Having any unstable or severe medical conditions that may interfere with study procedures or confound the evaluation of study endpoints, including previously diagnosed mania, depression, Alzheimer's disease, mood disorders, intellectual disability, other cognitive disorders, severe attention deficit, etc.\n9. Suffering from severe dysfunction of vital organs including heart, lung, liver and kidney: such as severe cardiovascular diseases (e.g., hospitalization or cardiac surgery due to myocardial infarction within 3 months, congestive heart failure, myocardial infarction, severe unstable arrhythmia, hypertrophic cardiomyopathy, severe aortic stenosis, aneurysm); severe pulmonary diseases (moderate to severe pneumonia, respiratory failure, etc.).\n10. Diagnosed with malignant tumors, autoimmune diseases, peripheral neuropathy, poorly controlled diabetes mellitus, or other severe diseases deemed unsuitable for this clinical trial by investigators.\n11. Severe spasticity, severe neuralgia, or uncontrolled complex regional pain syndrome that hinders participants from completing training sessions.\n12. Spinal cord dysfunction or injury caused by autoimmune disorders.\n13. Having visual impairment that makes it difficult to view display screens for a long time even with standard corrective lenses.\n14. Suffering from infectious diseases such as active pulmonary tuberculosis, viral hepatitis (hepatitis B, hepatitis C), syphilis and AIDS.\n15. Receiving pharmacotherapy or physical therapy affecting the central nervous system before enrollment, and unable to discontinue such treatments after enrollment as assessed by investigators.\n16. Having a history of drug abuse, nicotine dependence or alcohol dependence.\n17. Pregnant or lactating females, or those planning to become pregnant during the study period.\n18. Having participated or currently participating in any drug clinical trial within 90 days prior to enrollment, or any other medical device clinical trial within 30 days prior to enrollment.\n19. Any other conditions deemed inappropriate for participation in this clinical trial by investigators.","65 Years",{"count":49,"type":20},34,[23],"This is a prospective, open-label, multi-center, single-arm study to evaluate the efficacy and safety of an implantable wireless brain-machine interface (BMI) system in patients with spinal cord injury. Eligible participants will undergo screening after signing informed consent, followed by BMI system implantation. Follow-up visits will be conducted postoperatively to assess brain-control performance and safety.",[53],"Spinal Cord Injury","RECRUITING","2026-05-16",{"date":57,"type":31},"2026-05-22",{"date":59,"type":31},"2026-04-28",{"date":61,"type":20},"2027-06-30",{"name":37,"class":38},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":39},"100588702","a-study-on-the-safety-and-functionality-of-the-implantable-wireless-brain-computer-interfaces-for-motor-rehabilitation-100588702","NCT06944834","A Study on the Safety and Functionality of the Implantable Wireless Brain-Computer Interfaces for Motor Rehabilitation","STAIR","Inclusion Criteria:\n\n* Adults aged 18-65 years;\n* Patients with complete or incomplete quadriplegia due to spinal cord injury, brainstem stroke, amyotrophic lateral sclerosis (ALS), or other motor neuron diseases, or those with bilateral upper limb amputations;\n* Normal motor cortex function confirmed by neurological assessment;\n* Muscle strength of bilateral or unilateral upper limbs ≤ Grade 3;\n* Patients who have received standardized treatment and met diagnostic criteria for at least 12 months before screening, with stable disease status for ≥6 months;\n* Expected lifespan ≥12 months;\n* Normal cognitive function;\n* Normal hearing and vision, or corrected vision to normal with standard lenses;\n* Patients with stable caregivers;\n* Willing to sign informed consent and able to comply with follow-up requirements.\n\nExclusion Criteria:\n\n* Patients with neuropsychiatric disorders or psychological impairments;\n* Patients with brain MRI findings showing hemorrhage, tumors, anatomical abnormalities, or distortions;\n* History of severe systemic diseases (e.g., cardiac, pulmonary, hepatic, renal, thyroid, gastrointestinal, or hematologic disorders), poorly controlled diabetes, or pregnancy in females;\n* History of infectious diseases (e.g., syphilis, HIV), severe traumatic brain injury, or major surgeries;\n* Presence of metal implants or devices (e.g., cochlear implants, pacemakers, neurostimulators, defibrillators), except for dental implants or other implants deemed non-interfering;\n* Surgical or anesthesia contraindications as determined by surgeons or anesthesiologists;\n* Morbid obesity (BMI \\>40);\n* Hearing impairment or uncorrectable visual deficits that would hinder prolonged computer monitor viewing;\n* Current participation in other clinical trials;\n* Other conditions considered unsuitable by investigators or medical staff.",{"count":71,"type":20},5,[23],"The objective of this study is to evaluate the safety and efficacy of minimally invasive, wireless brain-machine interface system (WRS) in patients with paralysis (resulting from spinal cord injuries, brainstem strokes, amyotrophic lateral sclerosis, or other motor neuron diseases causing complete or incomplete quadriplegia) or bilateral upper limb amputations. By leveraging brain-machine interface alternative technology, participants can use brain signals to control external devices (such as moving cursors, wheelchairs, robotic arms, WeChat Mini Programs, and other physical assistive devices), thereby improving their motor function and quality of life.",[75,76,77,78],"Quadriplegia","Amputations","Spinal Cord Injuries (SCI)","Brainstem Stroke","2025-04-17",{"date":81,"type":31},"2025-04-25",{"date":83,"type":20},"2025-04",{"date":85,"type":20},"2027-04",{"name":37,"class":38},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":95,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":39},"100579816","research-on-wireless-brain-implant-system-for-general-control-of-external-devices-100579816","NCT06829212","Research on Wireless Brain Implant System for General Control of External Devices","A Prospective Clinical Trial to Evaluate the Safety and Efficacy of Implantable Wireless Recording System (WRS) for General Control of External Devices in Paralyzed\u002FAmputee Patients","RISE","Inclusion Criteria:\n\n* Aged 18-80 years (inclusive), any gender.\n* Diagnosed with spinal cord injury, brainstem stroke, amyotrophic lateral sclerosis, or other motor neuron diseases causing partial or complete paralysis, or bilateral upper limb amputation.\n* Diagnosis stable for at least 6 months before screening, with the condition present for at least 1 year.\n* Willing to follow the study protocol and attend all visits, with or without caregiver assistance.\n* Informed consent signed by participant and\u002For caregiver, with full understanding of the trial's purpose.\n\nExclusion Criteria:\n\n* Previous implantation of metal objects or devices (except dental implants or non-impacting implants).\n* Long-term use of anticoagulants\u002Fantiplatelets with insufficient cessation, or abnormal coagulation test results.\n* Unable to tolerate anesthesia or surgery.\n* Severe neurological disorders or brain injury leading to significant dysfunction.\n* Scalp conditions that may impair wound healing.\n* Acute or severe infections.\n* Cognitive impairment or psychiatric disorders.\n* Severe dysfunction of vital organs, malignancies, or autoimmune diseases.\n* Life expectancy under 1 year.\n* Drug or alcohol abuse.\n* Pregnant, breastfeeding, or planning pregnancy during the study.\n* Other conditions deemed unsuitable by the investigator.",{"count":5,"type":20},[23],"The clinical trial aims to evaluate the safety and efficacy of the minimally invasive, wireless brain-machine interface system (WRS) in enabling general brain control of external devices, such as a cursor and other assistive technologies, for paralyzed and amputee patients.\n\nWRS integrates a high-throughput, ultra-flexible neural electrode with an extremely small cross-sectional size-approximately one-hundredth the diameter of a human hair. Moreover, the implantable component is fully embedded within the body, leaving no visible external traces.",[99,53,78,100,101],"Complete or Incomplete Paraplegia\u002Fquadriplegia","Amyotrophic Lateral Sclerosis","Bilateral Upper Limb Amputation","2025-03-10",{"date":104,"type":31},"2025-03-13",{"date":106,"type":20},"2025-03",{"date":108,"type":20},"2027-02",{"name":37,"class":38},""]