[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brain-stem-stroke\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brain-stem-stroke":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,100],{"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":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":36,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100633072","interfacing-with-neurotechnology-to-expand-neural-throughput-intent-100633072",false,"NCT07521930","Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)","INTENT","Inclusion Criteria:\n\n* Complete or incomplete tetraplegia (quadriplegia), tetraparesis (quadriparesis), severe ataxia, or disabling motor impairments in both upper limbs, based on neurological exam. In addition, these motor impairments may be combined with severe motor-related speech impairment (dysarthria or anarthria), as in Locked In Syndrome (LIS) and amyotrophic lateral sclerosis (ALS), including the bulbar variant of ALS.\n* Clinical diagnosis must be established for the etiology of motor impairments, including brainstem stroke\\*, traumatic spinal cord injury (SCI), or progressive and irreversible neuromuscular disease, including muscular dystrophy and motor neuron disease, including amyotrophic lateral sclerosis (ALS). \\*Brain stem stroke is defined as an acute onset of neurological deficit with clinical features of brain stem or cerebellar dysfunction lasting more than 24 hours together with computed tomography (CT) or magnetic resonance imaging (MRI) evidence of ischemic infarction or parenchymal hemorrhage.\n* Candidates with traumatic spinal cord injury must have a complete or incomplete tetraplegia or tetraparesis (ASIA Impairment Scale A, B, C) with an injury level of C6 or higher.\n* Candidates with tetraplegia or tetraparesis from traumatic SCI and other non-progressive neurological disorders must have an upper extremity motor score (UEMS, ISNCSCI) of 7 or less in each of the upper extremities. Candidate must also have less than antigravity strength (\\\u003C 3) throughout the lower limbs.\n* Candidates with progressive conditions with shortened life expectancy, such as ALS, must have less than antigravity strength (\\\u003C3) throughout the upper limbs.\n* Persistence of motor impairments at least 12 months prior to enrollment if due to a non-progressive neurological cause such as stroke or spinal cord injury\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 speech or eye movement\n* Stable psychosocial support system with caregiver capable of monitoring participant throughout the study\n* Ability and willingness to travel to study location up to five days per week for the duration of the study\n* Ability to understand and comply with study session instructions\n* Corrected visual acuity sufficient for use of computer monitor\n\nExclusion Criteria:\n\n* Psychiatric conditions or cognitive impairments that would interfere with obtaining informed consent or fully participating in study activities.\n* Individuals with active implanted devices, including devices that are incompatible with magnetic resonance imaging (MRI).\n* Contraindications to MRI or anticipated need for an MRI during the study period\n* Medical conditions contraindicating device implantation surgery (for example significant pulmonary, cardiovascular, metabolic, or renal impairments making the surgical procedure unsafe)\n* Chronic anti-coagulation and medical contraindication to temporary suspension for surgery\n* Medical conditions contraindicating chronic device implantation (e.g. osteomyelitis, chronic infection, poorly controlled diabetes, cancer, severe autoimmune disorder, epilepsy, poor wound healing)\n* Participants with dental caries and a significant risk of dental or periodontal infection\n* Chronic oral or intravenous use of steroids or immunosuppressive therapy\n* Active cancer within the past year or ongoing chemotherapy\n* Uncontrolled autonomic dysreflexia within the past 3 months\n* Hydrocephalus with or without an implanted ventricular shunt\n* Other chronic, unstable medical conditions that could interfere with subject participation.\n* Persistent suicidal ideation within the past 12 months.\n* History of substance use disorder within the past year\n* Pregnancy (confirmation through blood test)\n* Nursing an infant, planning to become pregnant, or not using adequate birth control","ALL","18 Years","80 Years",{"count":20,"type":21},5,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to evaluate the safety and preliminary efficacy of an implantable device that records and stimulates different areas of the brain to allow adults affected by disabling paralysis (see Eligibility for more details) to control and receive feedback from assistive devices.",[27,28,29,30,31,32,33,34,35],"Tetraplegia\u002FTetraparesis","Amyotrophic Lateral Sclerosis (ALS)","Muscular Disorders, Atrophic","Brain Stem Stroke","Spinal Cord Injuries (SCI)","Muscular Dystrophies","Muscular Atrophy, Progressive","Pontine Hemorrhage","Pontine Infarction",[37,38],"Assistive device","Brain Computer Interface","RECRUITING","2026-04-02",{"date":42,"type":43},"2026-04-13","ACTUAL",{"date":45,"type":21},"2026-06",{"date":47,"type":21},"2028-12",{"name":49,"class":50},"Johns Hopkins University","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":70,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100602719","gb-prime-an-early-feasibility-study-of-a-precise-robotically-implanted-brain-computer-interface-for-the-control-of-external-devices-100602719","NCT07127172","GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices","GB-PRIME","Inclusion Criteria:\n\n* (a) A diagnosis of a spinal cord injury, brain stem stroke, or other neurological condition causing the participant to be non-ambulant and with bilateral upper limb motor impairment with no expectation of recovery that significantly or completely impairs the participant's ability to manually control a computer, smartphone or tablet with their hands.\n\nOR (b) A diagnosis of Amyotrophic Lateral Sclerosis (ALS) or other progressive neurological condition where the natural history of the disease is well understood and where there is tetraparesis and the expectation in the view of the participants treating neurologist that the disease will progress such that the participant will meet 1a within 1 year of recruitment.\n\n* Life expectancy ≥ 12 months.\n* Ability to communicate in English\n* Presence of a stable caregiver\n\nExclusion Criteria:\n\n* Moderate to high risk for serious perioperative adverse events\n* Active implanted devices\n* Morbid obesity (Body Mass Index \\> 40)\n* History of poorly controlled seizures or epilepsy\n* History of poorly controlled diabetes\n* Requires magnetic resonance imaging (MRI) for any ongoing medical conditions\n* Acquired or hereditary immunosuppression\n* Use of smoking tobacco or other tobacco products\n* Psychiatric or psychological disorder\n* Brain MRI demonstrating hemorrhage, tumor, distorted or adverse anatomy.\n* Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure",{"count":60,"type":21},7,[24],"The GB-PRIME Study is an early feasibility study designed to assess the clinical safety and functionality of the Neuralink N1 Implant and R1 Robot. This study involves participants who have tetraparesis, tetraplegia, or a diagnosis that may lead to these conditions.\n\nThe N1 Implant is a wireless, rechargeable device mounted on the skull, connected to electrode threads that are inserted into the brain by the R1 Robot, which is a robotic device specifically designed for this procedure.",[27,64,65,66,28,67,68,69,30],"Quadriplegia","Quadriplegia\u002FTetraplegia","Cervical Spinal Cord Injury","Spinal Cord Injury (Quadraplegia)","Spinal Cord Injury","Motor Neuron Disease",[71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88],"brain computer interface","Neuralink N1 Implant","Neuralink","Robot","tetraparesis","tetraplegia","quadriplegia","ALS","spinal cord injury","Amyotrophic lateral sclerosis","chip","brain chip","External device control","Wireless implant","Neuroprosthetics","SCI","paralysis","motor neuron disease","2025-08-11",{"date":91,"type":43},"2025-08-17",{"date":93,"type":43},"2025-07-31",{"date":95,"type":21},"2031-02",{"name":97,"class":98},"Neuralink Corp","INDUSTRY",2,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":112,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":51},"100592374","uae-prime-a-feasibility-study-of-a-precise-robotically-implanted-brain-computer-interface-for-the-control-of-external-devices-100592374","NCT06992596","UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices","UAE-PRIME","Inclusion Criteria:\n\n* (a) A diagnosis of a spinal cord injury (\\>12 months), stroke (\\>12 months), or other neurological condition causing the participant to experience bilateral upper limb motor impairment, with no expectation of recovery.\n\nOR (b) A diagnosis of Amyotrophic Lateral Sclerosis (ALS) or other progressive neurological condition where the natural history of the disease is well understood and where there is tetraparesis and the expectation, in the view of the participant's treating neurologist, that the disease will progress such that the participant will meet criteria 1a within 1 year of recruitment.\n\n* Life expectancy ≥ 12 months.\n* Ability to communicate verbally or with the use of a computer or communication aid, and working proficiency in English.\n* Presence of a stable caregiver\n\nExclusion Criteria:\n\n* Moderate to high risk for serious perioperative adverse events\n* Morbid obesity (Body Mass Index \\> 40)\n* History of poorly controlled seizures or epilepsy\n* History of poorly controlled diabetes\n* Requires magnetic resonance imaging (MRI) for any ongoing medical conditions\n* Acquired or hereditary immunosuppression\n* Smoking tobacco or use of other tobacco products \\> once per month within the last year.\n* Psychiatric or psychological disorder\n* Pre-existing damage to the cortical region of interest (as determined by MRI)\n* Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure",{"count":108,"type":21},10,[24],"The UAE-PRIME Study is a feasibility study designed to assess the initial clinical safety and functionality of the Neuralink N1 Implant and R1 Robot. This study involves participants who have tetraparesis, tetraplegia, or a diagnosis that may lead to these conditions.\n\nThe N1 Implant is a wireless, rechargeable device mounted on the skull, connected to electrode threads that are inserted into the brain by the R1 Robot, which is a robotic device specifically designed for this procedure.",[27,64,65,66,28,67,68,69,30],[71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88],"2025-06-03",{"date":115,"type":43},"2025-06-05",{"date":117,"type":43},"2025-05-09",{"date":119,"type":21},"2027-11",{"name":97,"class":98}]