[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brainstem-stroke\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brainstem-stroke":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,46,86,116,144,170,196,219],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100555426","feasibility-of-the-braingate2-neural-interface-system-in-persons-with-tetraplegia-bg-tablet-01-100555426",false,"NCT06511934","Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)","Intuitive, Complete Neural Control of Tablet Computers for Communication","BG-Tablet-01","Inclusion Criteria:\n\n* Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders\n* Complete or incomplete tetraplegia (quadriplegia)\n* Must live within a three-hour drive of the Study site\n* Prior enrollment in BrainGate2 clinical trial (NCT00912041)\n\nExclusion Criteria:\n\n* Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses\n* Chronic oral or intravenous steroids or immunosuppressive therapy\n* Other serious disease or disorder that could seriously affect ability to participate in the study\n\n(There are additional exclusion criteria)","ALL","18 Years","80 Years",{"count":21,"type":22},6,"ESTIMATED","INTERVENTIONAL",[25],"NA","People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals related to movement, and to further develop an intracortical brain-computer interface (iBCI) that could restore rapid and intuitive use of communication apps on tablet computers by people with paralysis.",[28,29,30,31,32],"Brainstem Stroke","ALS","Tetraplegia","Spinal Cord Injuries","Cervical Spinal Cord Injury","RECRUITING","2026-06-22",{"date":36,"type":37},"2026-06-25","ACTUAL",{"date":39,"type":37},"2024-07-22",{"date":41,"type":22},"2027-07-30",{"name":43,"class":44},"Leigh R. Hochberg, MD, PhD.","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100201147","cortical-recording-and-stimulating-array-brain-machine-interface-100201147","NCT01894802","Cortical Recording and Stimulating Array Brain-Machine Interface","A Sensorimotor Microelectrode Brain-Machine Interface for Individuals With Significant Upper Limb Impairment","CRS-BMI","Inclusion Criteria:\n\n1. Subjects must have limited or no ability to use one or both hands due to cervical spinal cord injury, brainstem stroke, brachial plexus injury, above-elbow amputation, or spinal stroke. Individuals with intact limbs must have less than grade 2 strength in finger flexor and abduction on the contralateral side to the implant and a t-score \\\u003C35 on the PROMIS Upper Extremity Short Form. The non-functional hand(s) may be involved passively in functional tasks; for example, pushing an object or passively grasping an object placed into the hand. However, the participant must report that they have no functional use of their hand(s).\n2. Subjects must report that they are unable to perform functional activities with the hand contralateral to implantation.\n3. Subjects must be over 1 year post-injury at time of implantation. In addition, subject must report no worsening in neurologic status (strength, sensation) for the previous 6 months.\n4. Subjects must be between the ages of 22-70 years old at the time of enrollment and completion of the study. Participants outside this age range may be at an increased surgical risk and increased risk of fatigue during BMI training.\n5. Subjects must live within 2 hours of the research site during the study or be willing to travel to the research site at least once per week for BMI training.\n6. If subjects do not live in the area, they are expected to stay somewhere within 2 hours of the research site for at least 18 months after enrollment.\n7. Subjects must be able to communicate with the investigators in English because of the need to follow the instructions of the study team.\n8. Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators\n9. Subjects must have results that are within normal limits on neuropsychological and psychosocial assessment; psychosocial health and support will be assessed by interview with the psychologist.\n10. Subjects must be able to activate distinct cortical areas during imagined or attempted movement tasks (i.e. hand movement and speaking or moving the mouth); this will be evaluated with functional magnetic resonance imaging (fMRI) as part of screening.\n11. Subjects must have a stable psychosocial support and caregivers who are able to perform the necessary daily care of the participant's skin and pedestal site. This requires that the subject identify a caregiver and a backup who have been in place for greater than 6 months and are able to provide needed physical and psychosocial support. This will be assessed by the sponsor-investigator and study neurosurgeon.\n12. Subjects must have a life expectancy greater than 18 months as assessed by the study investigator and neurosurgeon sub-investigator\n13. Documentation of informed consent must be obtained from the participant or their legal representative.\n14. Participants with transhumeral amputation must have been evaluated for a prosthesis, and if deemed appropriate, were fit with an optimized prosthesis. The prosthesis should be used\u002Fconsidered for the PROMIS evaluation.\n\nExclusion Criteria:\n\n1. Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses\n2. Another serious disease(s) or disorder(s) that could affect ability to participate in this study (verified during pre-op anesthesia evaluation to determine surgical risk status)\n3. Recent history of pressure sores that could be exacerbated by 1-2 days of bed rest\n4. Metallic implant(s) that would prohibit the subject from having an fMRI scan; spinal fixators are generally non-ferrous and would not exclude someone from participating in the study\n5. Any type of implantable generator such as a pacemaker, spinal cord stimulator, cochlear implant, deep brain stimulator (DBS), DBS leads, vagus nerve stimulator, or defibrillator\n6. Women of childbearing age who are pregnant, lactating, or plan to become pregnant during the next 25 months\n7. Allergy to contrast medium or kidney failure that could be exacerbated by contrast agent (for MRI)\n8. Subjects receiving medications (such as sedatives) chronically that may retard motor coordination and cognitive ability\n9. Individuals who require routine MRI, therapeutic ultrasound, or diathermy\n10. Individuals with osteomyelitis\n11. Severe skin disorder that causes excessive skin sloughing, lesions or breakdown of the scalp\n12. History of myocardial infarction or cardiac arrest or with intractable cardiac arrhythmias\n13. Individuals with an implanted hydrocephalus shunt\n14. Individuals who have had a stroke caused by a surgical procedure\n15. Active infection(s) or unexplained fever (verified during pre-op anesthesia evaluation to determine surgical risk status)\n16. Consumption of more than 1 alcoholic beverage per day on average\n17. Receiving chronic oral or intravenous steroids or immunosuppressive therapy\n18. Active cancer within the past year (other than adequately treated basal cell or squamous cell skin cancer) or require chemotherapy\n19. Uncontrolled insulin dependent diabetes mellitus\n20. Uncontrolled autonomic dysreflexia within the past 3 months (for those with spinal cord injury)\n21. Individuals with seizure disorders currently being treated with anti-epileptic medications and individuals with a familial history of seizure disorders\n22. Individuals who have attempted suicide in the past 12 months\n23. Individuals who are immunosuppressed or who have conditions that typically result in immunocompromise (including, but not limited to: ataxia-telangiectasia, cancer, Chediak-Higashi syndrome, combined immunodeficiency disease, complement deficiencies, DiGeorge syndrome, HIV\u002FAIDS, hypogammaglobulinemia, Job syndrome, leukocyte adhesion defects, malnutrition, panhypogammaglobulinemia, Bruton disease, congenital agammaglobulinemia, selective deficiency of IgA and Wiscott-Aldrich syndrome)\n24. Individuals who have had previous neurosurgical intervention involving the frontal lobes (especially the motor cortex) and\u002For parietal lobe (especially the somatosensory cortex) that is likely to impact the viability of an intracortical electrode\n25. Individuals with active psychiatric concerns, including but not limited to major depression, bipolar disorder, schizophrenia or other psychotic disorder and post-traumatic stress disorder\n26. Individuals with substance abuse within 6 months of study participation\n27. Individuals who are judged by a clinician as being an unsafe ambulator - This would be decided based on a history of frequent uncontrolled falls more than 3 or 4 in a year, or falls that resulted in injury\n28. Individuals who plan to participate in contact sports or sports that require a helmet","22 Years","70 Years",{"count":57,"type":22},30,[25],"The purpose of this research study is to demonstrate the safety and efficacy of using two CRS Arrays (microelectrodes) for long-term recording of brain motor cortex activity and microstimulation of brain sensory cortex.",[30,61,28,62,63],"Spinal Cord Injury","Brachial Plexus Injury","Above Elbow Amputation",[30,65,66,67,68,69,70,71,72,73,74,75],"Quadriplegia","Spinal cord injury","Brainstem or spinal stroke","Neuroprosthetic","Brain-machine interface","Brain-computer interface","Neural activity","Sensory stimulation","Microstimulation","Brachial plexus injury","Above elbow amputation","2026-05-18",{"date":78,"type":37},"2026-05-20",{"date":80,"type":37},"2013-12-01",{"date":82,"type":22},"2029-12",{"name":84,"class":44},"Michael Boninger",2,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":97,"conditions":98,"keywords":102,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":45},"100608723","rainbow-ich-trial-of-ai-guided-minimally-invasive-neurosurgery-for-ich-100608723","NCT07205263","RAINBOW-ICH Trial of AI Guided Minimally Invasive Neurosurgery for ICH","A Multicenter, Randomized, Controlled, Umbrella Trial for Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Hemorrhagic Stroke (RAINBOW-ICH)","RAINBOW-ICH","Umbrella Trial Inclusion Criteria:\n\n1. Age ≥18 years；\n2. Clinical diagnosis of spontaneous hemorrhagic stroke；\n\nUmbrella Trial Exclusion Criteria:\n\n1\\. Radiologically diagnosed cerebrovascular abnormalities, as well as ischemic infarction converting to intracerebral hemorrhage, or recent (within 1 year) recurrence of intracerebral hemorrhage；\n\nEach substudy will specify additional inclusion and exclusion criteria in the respective Substudy-specific Registration. Patients who fulfill the overall umbrella trial criteria will be assessed for enrollment into each substudy.",{"count":95,"type":22},1000,[25],"Intracerebral hemorrhage (ICH) is one of the most devastating forms of stroke, with high rates of death and disability worldwide. Despite advances in medical and surgical care, effective therapeutic options remain limited. To address this gap, the RAINBOW-ICH trial has been designed as a nationwide, multicenter, randomized umbrella trial evaluating the efficacy and safety of AI-assisted, robotic-guided minimally invasive neurosurgery compared with conventional strategies across major ICH subtypes.\n\nUnder a single master protocol, RAINBOW-ICH incorporates multiple parallel randomized controlled substudies, each targeting a distinct ICH population-large basal ganglia hemorrhage, moderate basal ganglia hemorrhage, intraventricular hemorrhage, and brainstem hemorrhage. This umbrella design allows efficient use of resources while generating high-quality evidence tailored to the specific needs of different ICH subgroups, thereby supporting a more patient-centered approach to care.",[99,100,28,101],"Basal Ganglia Hemorrhage","Intraventricular Hemorrhage","Intracranial Hemorrhage, Spontaneous",[103,104,28,105,99,106],"Umbrella Trial","Intraventricular hemorrhage","Robotic-guided","Minimally invasive surgery","2026-01-06",{"date":109,"type":37},"2026-01-08",{"date":111,"type":37},"2025-09-30",{"date":113,"type":22},"2027-12",{"name":115,"class":44},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":125,"briefSummary":126,"conditions":127,"keywords":131,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":45},"100532037","investigation-on-the-cortical-communication-system-100532037","NCT06207591","Investigation on the Cortical Communication System","Investigation on the Cortical Communication (CortiCom) System","CortiCom","Inclusion Criteria:\n\n* 18-70 years\n* Clinical diagnosis of locked-in state state or likelihood of soon progressing into LIS (within an estimated 2 years), caused by traumatic brain injury, brainstem stroke, neurodegenerative disease, neuromuscular disease or another cause\n* • Current or imminent complete or incomplete tetraplegia (quadriplegia) or tetraparesis (quadriparesis)\n* • Current or imminent motor-related speech impairment (dysarthria or anarthria)\n* Either receiving tracheostomy invasive ventilation, or having a stable and adequate respiratory situation without respiratory support, allowing for safe intubation, mechanical ventilation and detubation during surgery according to the involved clinicians, and, if relevant (e.g., in case of a progressive condition), in combination with a confirmed desire to receive tracheostomy invasive ventilation when that becomes necessary\n* Meeting surgical safety criteria, including surgical clearance by the study physicians\n* Meeting (neuro)psychological evaluation criteria\n* Ability to communicate reliably, such as through eye movement\n* Willingness and ability to provide informed consent\n* Lives within reasonable distance from University Medical Center Utrecht\n* Participant consents to the study and still wishes to participate at the time of the study\n* Vision and hearing largely intact\n\nExclusion Criteria:\n\n* Performance on formal neuropsychological testing that indicates a significant current or recent psychiatric disorder, cognitive or behavioral impairment, that would interfere with obtaining informed consent or fully participating in study activities\n* Medical conditions contraindicating surgery of a chronically implanted device or that could interfere with study participation (for example active infections, unexplained fever, existing scalp lesions or skin breakdown, osteomyelitis, hepatitis, any autoimmune disease\u002Fdisorder, epilepsy, skin disorders causing excessive skin sloughing or poor wound healing, cranioplasty, significant cardiovascular, metabolic, or renal impairments, chronic oral or intravenous use of steroids or immunosuppressive therapy, active cancer within the past year or requires chemotherapy, uncontrolled autonomic dysreflexia within the past 3 months, hydrocephalus with or without an implanted ventricular shunt or a medical contraindication to stop anti-coagulant medications during surgery)\n* Presence of pre-surgical findings in anatomical, functional, and\u002For vascular neuroimaging that makes achieving implant locations too challenging or incompatible with desired risk levels\n* Inability to undergo MRI for pre-implantation evaluation, for example due to the presence of implanted devices that are incompatible with MRI, which may include pacemakers, cardiac defibrillators, spinal cord or vagal nerve stimulators, deep brain stimulators, and cochlear implants\n* Anticipated need for MRI after implantation of the CortiCom assembly",{"count":85,"type":22},[25],"The goal of this clinical trial is to demonstrate communication through a brain implant in people in locked-in state, i.e. people with severe paralysis and communication problems.\n\nThe main questions it aims to answer are efficient and stable control of Brain-Computer interface (BCI) functions for communication with attempted hand movements and operation of a keyword-based speech BCI.\n\nParticipants will be implanted with four electrode grids, with in total 128 electrodes, on the surface of the brain and a connector on the skull. Participation includes visits of researchers for recording and training at home, 2-3 times per week for one year. Extension of participation after one year is possible.\n\nIf successful, the participant will be able to use the BCI at home independently, without the presence of a researcher.",[128,129,28,130],"Locked-in Syndrome","Neuromuscular Diseases","Traumatic Brain Injury",[132,133,134],"Locked-in","Amyotrophic lateral sclerosis","Neurodegenerative disease","2025-09-29",{"date":137,"type":37},"2025-10-03",{"date":139,"type":37},"2023-12-15",{"date":141,"type":22},"2029-09",{"name":143,"class":44},"UMC Utrecht",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":121,"officialTitle":121,"acronym":122,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":149,"targetDuration":4,"studyType":23,"phases":151,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":45},"100329283","investigation-on-the-cortical-communication-corticom-system-100329283","NCT03567213","Inclusion Criteria:\n\n* Clinical diagnosis of tetraplegia (quadriplegia), brainstem stroke , amyotrophic lateral sclerosis (ALS) or Locked-in Syndrome (LIS)\n* Tetraplegia diagnosis, ALS diagnosis, stroke, or LIS etiology onset occurred at least one year prior to enrollment\n* Complete or incomplete tetraplegia (quadriplegia), tetraparesis (quadriparesis), or severe ataxia. In addition, these motor impairments may be combined with severe motor-related speech impairment (dysarthria or anarthria), as in LIS.\n* 22-70 years\n* Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants\n* Ability to communicate reliably, such as through eye movement\n* Willingness and ability to provide informed consent\n* Screened by rehabilitation psychologist with a result showing that the participant has a stable psychosocial support system with caregiver capable of monitoring participant throughout the study\n* Ability and willingness to travel up to 100 miles to study location up to three days per week for the duration of the study\n* Ability to understand and comply with study session instructions\n* Participant consents to the study and still wishes to participate at the time of the study\n\nExclusion Criteria:\n\n* Performance on formal neuropsychological testing that indicates significant psychiatric conditions or cognitive impairments that would interfere with obtaining informed consent or fully participating in study activities.\n* Suicide attempt or persistent suicidal ideation within the past 12 months.\n* Implanted devices that are incompatible with MRI, which may include pacemakers, cardiac defibrillators, spinal cord or vagal nerve stimulators, deep brain stimulators, and cochlear implants.\n* History of substance abuse, narcotic dependence, or alcohol dependence in past 24 months\n* Medical conditions contraindicating surgery of a chronically implanted device (e.g. osteomyelitis, diabetes, hepatitis, any autoimmune disease\u002Fdisorder, epilepsy, skin disorders causing excessive skin sloughing or poor wound healing, blood or cardiac disorder requiring chronic anti-coagulation)\n* Other chronic, unstable medical conditions that could interfere with subject participation.\n* Presence of pre-surgical findings in anatomical, functional, and\u002For vascular neuroimaging that makes achieving implant locations within desired risk levels too challenging (to be decided by neurological and neurosurgical team)\n* Prior cranioplasty\n* Inability to undergo MRI or anticipated need for an MRI during the study period\n* Participants with active infections or unexplained fever\n* Participants with other morbid conditions making the implantation of the recording elements unsafe; not limited to: significant pulmonary, cardiovascular, metabolic, or renal impairments making the surgical procedure unsafe\n* Pregnancy (confirmation through blood test)\n* Nursing an infant, planning to become pregnant, or not using adequate birth control\n* Corrected vision poorer than 20\u002F100\n* HIV or AIDS infection\n* Existing scalp lesions or skin breakdown\n* Chronic oral or intravenous use of steroids or immunosuppressive therapy\n* Active cancer within the past year or requires chemotherapy\n* Uncontrolled autonomic dysreflexia within the past 3 months\n* Hydrocephalus with or without an implanted ventricular shunt\n* Participants in whom it is medically contraindicated to stop anti-coagulant medications during surgery",{"count":150,"type":22},3,[25],"The CortiCom system consists of 510(k)-cleared components: platinum PMT subdural cortical electrode grids, a Blackrock Microsystems patient pedestal, and an external NeuroPort Neural Signal Processor. Up to two grids will be implanted in the brain, for a total channel count of up to 128 channels, for six months. In each participant, the grid(s) will be implanted over areas of cortex that encode speech and upper extremity movement.",[30,128,28,154],"Amyotrophic Lateral Sclerosis",[30,29,128,156,157,158,159,160],"Brainstem stroke","Brain Computer Interface","Rehabilitation","Stroke","Hopkins","2025-07-22",{"date":163,"type":37},"2025-07-25",{"date":165,"type":37},"2021-12-14",{"date":167,"type":22},"2026-08-31",{"name":169,"class":44},"Johns Hopkins University",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":177,"enrollmentInfo":178,"targetDuration":4,"studyType":23,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":185,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":45},"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.","65 Years",{"count":179,"type":22},5,[25],"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.",[65,183,184,28],"Amputations","Spinal Cord Injuries (SCI)","NOT_YET_RECRUITING","2025-04-17",{"date":188,"type":37},"2025-04-25",{"date":190,"type":22},"2025-04",{"date":192,"type":22},"2027-04",{"name":194,"class":195},"Shanghai StairMed Technology Co., Ltd.","INDUSTRY",{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":204,"targetDuration":4,"studyType":23,"phases":206,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":45},"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":205,"type":22},4,[25],"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.",[209,61,28,154,210],"Complete or Incomplete Paraplegia\u002Fquadriplegia","Bilateral Upper Limb Amputation","2025-03-10",{"date":213,"type":37},"2025-03-13",{"date":215,"type":22},"2025-03",{"date":217,"type":22},"2027-02",{"name":194,"class":195},{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":177,"enrollmentInfo":227,"targetDuration":4,"studyType":23,"phases":229,"briefSummary":231,"conditions":232,"keywords":235,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":85},"100523108","phase-2-hemorrhagic-brainstem-cavernous-malformations-treatment-with-sirolimus-asingle-centre-randomized-placebo-controlled-pilot-trial-100523108","NCT06091332","Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: aSingle Centre, Randomized, Placebo-controlled Pilot Trial","Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: a Randomized, Placebo-controlled Pilot Trial","CALM","Inclusion Criteria:\n\n1. Age 18-65 years, any gender;\n2. Patients who have experienced their first symptomatic BSCM ICH within the six months before randomisation;\n3. Diagnosed with solitary BSCM through T2, GRE\u002FT2\\*, or SWI MR imaging;\n4. ICH within or around the BSCM confirmed by CT \u002FMR;\n5. Capable of signing an informed consent form with the accompaniment and understanding of a guardian.\n\nExclusion Criteria:\n\n1. Cancer history;\n2. Pregnancy or lactation;\n3. Sirolimus\u002Fstarch allergy;\n4. Modified Rankin Scale (mRS) score 5, respiratory failure or currently severe bleeding requiring life support treatment;\n5. Abnormal liver and\u002For kidney function (transaminase levels greater than 50, creatinine greater than 110), abnormal white blood cell\u002Fplatelet counts (white blood cell count below 3.5 or above 9.5 x 109\u002FL or exceeding normal values, platelet count below 100 or above 300);\n6. History of previous immunosuppressive therapy;\n7. History of prior surgical intervention for CCM ;\n8. History of prior cranial radiation therapy ;\n9. Familial CCM or people with multiple CCM;\n10. Patients with concurrent acute active infections (e.g., severe bacterial, viral, or fungal infections);\n11. Uncontrolled diabetes mellitus;\n12. Currently participating in another clinical trial;\n13. Patient unwilling\u002Funable to undergo MRI.\n14. Co-administration of drugs affecting CYP3A4 enzymes (ketoconazole, voriconazole, itraconazole, telithromycin, clarithromycin).",{"count":228,"type":22},75,[230],"PHASE2","The aim of this pilot phase trial is to assess the safety and tolerability, and estimate the efficacy of sirolimus in reducing the incidence of ICH during high-risk periods for rebleeding, compared to placebo. This pilot trial will inform the design of a future definitive clinical trial on sirolimus treatment for CCM.",[233,234,28],"Cavernous Malformations","Intracerebral Hemorrhage",[233,236,237,238],"Brainstem","Rebleeding rate","Sirolimus","2024-12-17",{"date":241,"type":37},"2024-12-20",{"date":243,"type":37},"2024-01-05",{"date":245,"type":22},"2026-12-31",{"name":247,"class":44},"Huashan Hospital"]