[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tetraplegic-motor-dysfunction-following-brainstem-or-spinal-cord-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tetraplegic-motor-dysfunction-following-brainstem-or-spinal-cord-injury":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":34,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100511221","mindex-a-novel-multifocal-cognitive-brain-machine-interface-system-100511221",false,"NCT05936619","MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System","Inclusion Criteria:\n\n* Paralysis resulting from cervical spinal cord injury (SCI), brainstem stroke (ischemic or hemorrhagic), or amyotrophic lateral sclerosis (ALS)\n* Provide informed consent\n* Understand and comply with instructions, if necessary, with the aid of a translator\n* Communicate via speech or other means\n* Surgical clearance\n* Life expectancy greater than 12 months\n* Travel to study locations up to five days per week for the duration of the study\n* Caregiver monitor for surgical site complications and behavioral changes on a daily basis\n* Psychosocial support system\n* Stable ventilator status\n\nExclusion Criteria:\n\n* Presence of memory problems\n* Intellectual impairment\n* Psychotic illness or chronic psychiatric disorder, including major depression if untreated\n* Poor visual acuity\n* Pregnancy\n* Active infection or unexplained fever\n* Scalp lesions or skin breakdown\n* HIV or AIDS infection\n* Active cancer or chemotherapy\n* Diabetes\n* Autonomic dysreflexia\n* History of seizure\n* Implanted hydrocephalus shunt\n* Prior cranioplasty\n* Other implanted devices\n* Medical conditions contraindicating surgery and chronic implantation of a medical device\n* Unable to undergo MRI or anticipated need for MRI during the study\n* Breastfeeding an infant (direct nursing or via a bottle of expressed milk)\n* Chronic oral or intravenous use of steroids or immunosuppressive therapy\n* Suicidal ideation\n* Drug or alcohol dependence\n* Planning to become pregnant, or unwilling to use adequate birth control","ALL","18 Years","65 Years",{"count":5,"type":19},"ESTIMATED","INTERVENTIONAL",[22],"NA","This research study is being done to develop a novel brain-computer interface (BCI) technology that can enable severely paralyzed individuals to interact with the world through direct brain-control of a computer. This technology is named MindEx (for Mind Extender). It utilizes four implanted \"chips\" in the human brain from which investigators can record brain activity during subjects' thoughts and decode meaningful information from this activity to be used as control signals for a computer, a laptop, or a tablet. The use of four brain regions is a significant differentiating feature and scientific innovation of this study over much prior work in this space, that typically derived control signals from one, or sometimes two brain regions. The brain regions to be used here can allow the decode of multiple variables simultaneously, including not just moment-to-moment position, but also high-level goals, intentions, decisions, scene comprehension, and error-related signals involved in natural human behavior. The research is being done through a prospective, longitudinal, single-arm early feasibility study to examine the safety and effectiveness of using MindEx to provide the user an intuitive, efficient, and accurate ability to control multiple applications on a computer interface such as a word processor, a paint application, or to play simple video games. Such versatility could greatly improve the autonomy and quality of life of severely paralyzed individuals. Two subjects will be enrolled, each implanted with MindEx for a period of at least 53 weeks and up to 313 weeks. The study is expected to take at least one year and up to six years in total.",[25,26,27,28,29,30,31,32,33],"Paralysis; Quadriplegic","Quadraplegia","Tetraplegia","Tetraplegic Motor Dysfunction Following Brainstem or Spinal Cord Injury","Cervical Spinal Cord Injury","Amyotrophic Lateral Sclerosis (ALS)","Brainstem Stroke","Paralysis","Brain-computer Interface",[35,36,37,38,39,26,27,29,31,40],"spinal cord injury","brain-computer interface","brain-machine interface","paralysis","Quadriplegic","ALS","RECRUITING","2026-09-29",{"date":44,"type":45},"2026-10-01","ACTUAL",{"date":47,"type":45},"2026-02-20",{"date":49,"type":19},"2031-09-01",{"name":51,"class":52},"Nader Pouratian","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":62,"targetDuration":4,"studyType":20,"phases":64,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":53},"100628131","safety-and-efficacy-of-high-channel-implanted-bci-for-motor-function-improvement-in-tetraplegia-patients-100628131","NCT07457645","Safety and Efficacy of High-Channel Implanted BCI for Motor Function Improvement in Tetraplegia Patients","Safety and Efficacy of High-Channel Implanted Brain-Computer Interface in Promoting Motor Function Improvement in Patients With Tetraplegia","HC-IBCI-SE-TMF","Inclusion Criteria:\n\n* 18-65 years old (no gender restriction)\n* Clinically diagnosed with tetraplegic motor dysfunction following brainstem or spinal cord injury\n* ≥ 6 months after brainstem or spinal cord injury, with stable condition (spinal shock phase has passed, and no significant improvement or deterioration in sensory and motor function)\n* Bilateral upper limb muscle strength ≤ Grade 2 and bilateral lower limb muscle strength ≤ Grade 3 by Manual Muscle Testing (MMT)\n* Cognitive function: Mini-Mental State Examination (MMSE) score ≥ 20\n\nExclusion Criteria:\n\n* Females who are pregnant\n* History of drug abuse or alcoholism\n* Diseases that limit limb mobility: fractures (progressive\u002Fdeformity-causing fractures), hip dysplasia and other diseases causing limited hip mobility, diabetic foot, severe osteoporosis, limb joint contracture deformity, spasticity, and hospitalization due to autonomic dysreflexia in the past 3 months\n* Neurological diseases\u002Finjuries: traumatic brain injury, epilepsy, neurodegenerative diseases or neuropathies, severe anxiety or depression, and suicidal ideation\n* Surgical contraindications: infectious diseases; unstable angina pectoris, severe arrhythmia, and other heart diseases; immune system diseases and major organ diseases; coagulation disorders and bleeding tendencies; ankylosing spondylitis; malignant tumors; spinal instability and spinal stenosis\n* BMI ≥ 30.0 kg\u002Fm²\n* Patients with depressive disorder (17-item Hamilton Depression Rating Scale \\[HAMD\\] score \\> 17)\n* Patients unable to comply with the study protocol",{"count":63,"type":19},10,[22],"This is an open-label single-arm clinical study conducted at designated clinical trial institutions, with three overall phases: a 3-month main study, a 3-month extension, and a 3-month follow-up. The main study includes screening\u002Fbaseline, preoperative preparation, surgery, upper limb rehabilitation adjustment, and pneumatic hand function training-specifically, preoperative brain and spinal cord imaging for electrode placement in eligible subjects, implantation of high-channel electrodes, and postoperative combined rehabilitation to build a motor intention decoding model that drives the pneumatic hand to grasp. The extension phase focuses on precise assessment of upper limb grasping function, signal stability monitoring, implantation of epidural spinal cord test electrodes, and closed-loop regulated epidural electrical stimulation for limb rehabilitation using implanted intracranial electrode signals. The follow-up phase involves intracranial electrode removal, implantation of long-term epidural spinal cord electrodes, and limb rehabilitation training and observation based on scalp EEG signals.",[28],"NOT_YET_RECRUITING","2026-04-22",{"date":70,"type":45},"2026-04-28",{"date":72,"type":19},"2026-05-15",{"date":74,"type":19},"2028-10-15",{"name":76,"class":52},"Shanghai Zhongshan Hospital"]