[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"quadriplegia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:quadriplegia":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,43,76,110,137,166,202,224,245,267,291],{"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":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":21},"100642753","innovative-brain-computer-interface-for-people-with-spinal-cord-injury-100642753",false,"NCT07640711","Innovative Brain-Computer Interface for People With Spinal Cord Injury","Innovative Neurotechnology For Society - Brain-Computer Interface","INTENSE-BCI","Inclusion Criteria:\n\n* Clinical diagnosis of SCI at the cervical level C4 or higher (C1-C4)\n* Complete or incomplete tetraplegia (quadriplegia) or tetraparesis (quadriparesis), i.e., level A or B at the American Spinal Injury Association (ASIA) Impairment Scale\n* Meeting surgical safety criteria, including surgical clearance by the study physicians\n* Meeting (neuro)psychological evaluation criteria\n* Ability to communicate reliably, via speech or other means\n* Willingness and ability to provide informed consent.\n* Lives within reasonable distance from UMC 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* For candidates who are not currently receiving invasive ventilation, and who have current respiratory problems (e.g., at night), there should be a clear and confirmed desire to proceed with tracheostomy ventilation whenever that would become necessary.\n\nExclusion Criteria:\n\n* Having a spinal cord injury with a degenerative or progressive etiology.\n* Having evident swallowing problems.\n* Having a significant current or recent anxiety disorder or depression or cognitive 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, or a catabolic state, or strong and frequent spasms)\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 or devices that deliver diaphragm pacing.\n* Anticipated need for MRI after implantation of the Brain InterChange system.","ALL","18 Years","70 Years",{"count":21,"type":22},1,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to demonstrate control of digital devices through a brain implant in people with spinal cord injury. The main question it aims to answer is efficient, independent, BCI-based control over digital devices in settings of daily living of an individual with SCI. In this project an advanced generation fully implantable BCI system will be used, the Brain InterChange (BIC) from CorTec.\n\nParticipants will be implanted with an electrode grid on the surface of the brain and an amplifier\u002Ftransmitter on the skull, under the skin. Participation includes visits of researchers for recording and training at home, 1-3 times per week for one year. Extension of participation after one year is possible. If successful, the participant will be able to use the BCI at home independently, without the presence of a researcher.",[28,29,30],"Spinal Cord Injury","Tetraplegia C1-C4","Quadriplegia","RECRUITING","2026-06-05",{"date":34,"type":35},"2026-06-11","ACTUAL",{"date":37,"type":22},"2026-08",{"date":39,"type":22},"2028-08",{"name":41,"class":42},"UMC Utrecht","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100205982","visuomotor-prosthetic-for-paralysis-100205982","NCT01958086","Visuomotor Prosthetic for Paralysis","Inclusion Criteria:\n\n* Pathology resulting in paralysis\n* Age 22-65 years\n* Able to provide informed consent\n* Understand and comply with instructions, if necessary, with the aid of a translator\n* Able to communicate via speech\n* Surgical clearance\n* Life expectancy greater than 12 months\n* Live within 60 miles of study location and willing to travel up to 5 days per week\n* A regular caregiver to monitor the surgical site\n* Psychosocial support system\n* Stable ventilator status\n\nExclusion Criteria:\n\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* Medically uncontrolled diabetes\n* Autonomic dysreflexia\n* History of seizure\n* Implanted hydrocephalus shunt\n* History of supratentorial brain injury or neurosurgery\n* Medical conditions contraindicating surgery and chronic implantation of a medical device\n* Unable to undergo MRI or anticipated need for MRI during study\n* Nursing an infant or unwilling to bottle-feed infant\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\n* Implanted Cardiac Defibrillator, Pacemaker, vagal nerve stimulator, or spinal cord stimulator.","22 Years","65 Years",{"count":52,"type":22},2,[25],"The investigators objective is to run human clinical trials in which brain activity recorded through a \"brain-chip\" implanted in the human brain can be used to provide novel communication capabilities to severely paralyzed individuals by allowing direct brain-control of a computer interface. A prospective, longitudinal, single-arm early feasibility study will be used to examine the safety and effectiveness of using a neural communication system to control a simple computer interface and a tablet computer. Initial brain control training will occur in simplified computer environments, however, the ultimate objective of the clinical trial is to allow the human patient autonomous control over the Google Android tablet operating system. Tablet computers offer a balance of ease of use and functionality that should facilitate fusion with the BMI. The tablet interface could potentially allow the patient population to make a phone call, manage personal finances, watch movies, paint pictures, play videogames, program applications, and interact with a variety of \"smart\" devices such as televisions, kitchen appliances, and perhaps in time, devices such as robotic limbs and smart cars. Brain control of tablet computers has the potential to greatly improve the quality of life of severely paralyzed individuals. Five subjects will be enrolled, each implanted with the NCS 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.",[30],[57,58,59,60,61,62,63,64,65],"Neural","Prosthetic","brain machine interface","brain computer interface","brain control","paralysis","tetraplegia","quadriplegia","spinal cord injury","2026-03-16",{"date":68,"type":35},"2026-03-18",{"date":70,"type":35},"2013-10-01",{"date":72,"type":22},"2031-07-31",{"name":74,"class":42},"Richard A. Andersen, PhD",3,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":95,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":52},"100549109","precise-robotically-implanted-brain-computer-interface-100549109","NCT06429735","Precise Robotically IMplanted Brain-Computer InterfacE","PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices","PRIME","Inclusion Criteria:\n\n* Severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) for at least 1 year without improvement, where quadriplegia is defined as having very limited or no hand, wrist, and arm movement and all levels below\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","75 Years",{"count":86,"type":22},15,[25],"The PRIME Study is a first-in-human early feasibility study to evaluate the initial clinical safety and device functionality of the Neuralink N1 Implant and R1 Robot device designs in participants with tetraparesis or tetraplegia. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.",[90,30,91,92,93,94],"Tetraplegia\u002FTetraparesis","Cervical Spinal Cord Injury","Amyotrophic Lateral Sclerosis","Quadriplegia\u002FTetraplegia","Tetraplegic; Paralysis",[65,96,97,60,98,64,99,62],"SCI","BCI","ALS","tetraplegic","2026-01-07",{"date":102,"type":35},"2026-01-09",{"date":104,"type":35},"2024-01-09",{"date":106,"type":22},"2031-01",{"name":108,"class":109},"Neuralink Corp","INDUSTRY",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":84,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":21},"100610182","voice-an-early-feasibility-study-of-a-precise-robotically-implanted-brain-computer-interface-for-communication-restoration-100610182","NCT07224256","VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration","Inclusion Criteria:\n\nAdults with diagnosis of ALS, PLS, stroke, or Spinal Cord Injury who have severe speech impairment and impaired upper limb function.\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* 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* 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":117,"type":22},6,[25],"The VOICE Study is an early feasibility study to evaluate the initial clinical safety and efficacy of the N1 and R1 Systems device design concept in providing an ability to communicate. The Neuralink N1 Implant is intended to provide the ability to communicate to individuals with severe and irreversible speech production impairment. It is indicated for adults with neurological conditions of the central speech pathways who have impaired upper limb function. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.",[90,30,91,92,93,94,121],"Stroke",[123,65,96,98,60,97,124,125,126,127,128],"stroke","PLS","voice","speech","dysarthria","neuralink","2025-10-31",{"date":131,"type":35},"2025-11-04",{"date":133,"type":35},"2025-10-03",{"date":135,"type":22},"2031-10",{"name":108,"class":109},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":146,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":21},"100298134","investigation-on-the-bidirectional-cortical-neuroprosthetic-system-100298134","NCT03161067","Investigation on the Bidirectional Cortical Neuroprosthetic System","BiCNS","Inclusion Criteria:\n\nParticipants must meet all inclusion criteria, verified by medical evaluation, psychological evaluation, and review of medical history. Inclusion criteria include:\n\n* Participants with C4-C6 tetraplegia from any etiology except neurodegenerative disease (e.g. amyotrophic lateral sclerosis) or active cancer.\n* Complete or incomplete spinal cord injury classified by the American Spinal Injury Association (ASIA) as A or B or C if fewer than three muscle groups in the leg and foot (as identified in the ASIA Impairment Scale) can be contracted\n* Injury more than one year prior to enrollment\n* Participant has a life expectancy of greater than 5 years\n* Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants\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 to up to fifty 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* Pain well controlled without narcotic medications\n* No other neurological, orthopedic conditions beyond the spinal cord injury\n* Participant consents to the study and still wishes to participate at the time of the study\n\nExclusion Criteria:\n\nAll interested participants will be reviewed for the presence of exclusion criteria by medical evaluation, review of medical history, self (or assistant) report and evaluation by a psychologist. Presence of any of the following criteria will exclude participants from eligibility to participate. In addition, the medical team has the right to withdraw the participant at any time if any of the exclusion criteria emerge and participants can withdraw at any time for any reason. Withdrawal details are outlined below exclusion criteria. Exclusion criteria include:\n\n* Neurological conditions: Impaired receptive and\u002For expressive verbal communication skills\n* Presence of memory impairment on the Rey Auditory Verbal Learning Test\n* Intellectual impairment: score of 26 or less on the Mini-Mental State Examination or history of Intelligence Quotient \\\u003C 80\n* Chronic psychiatric illness, including psychosis and treatment-resistant major depression, as indicated by a diagnosis of Axis I or Axis II on the Symptom Checklist-90-Revised Test\n* Ventilator dependent\n* Implanted devices such as: pacemakers, cardiac defibrillators, spinal cord or vagal nerve stimulators, deep brain stimulators, cochlear implants or any other implantable device incompatible with MRI.\n* History of drug or alcohol dependence in past 24 months\n* Cerebral lesions affecting frontal and parietal lobes\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 make control unsuitable (such as tremor or spasticity)\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, 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 no worse than 20\u002F30\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* An implanted ventricular shunt\n* Suicidal ideation within the past 12 months\n* Medications that affect neuroplasticity: neuroleptics, Benzodiazepines (BDZ), Tricyclic Antidepressants (TCA).",{"count":145,"type":22},5,[25],"The Bidirectional Cortical Neuroprosthetic System (BiCNS) consists of NeuroPort Microelectrode Array Systems and NeuroPort Electrodes (Sputtered Iridium Oxide Film), Patient Pedestals, the NeuroPort BioPotential Signal Processing System, and the CereStim C96 Programmable Stimulator. The goals of this early feasibility study consist of safety and efficacy evaluations of this device.",[149,30],"Tetraplegia",[149,151,152,153,154,155,156,30],"Rehabilitation","Brain Computer Interface","Intracortical Microstimulation","Upper extremity prosthetics","Cervical spinal cord injury","Bilateral","2025-09-02",{"date":159,"type":35},"2025-09-09",{"date":161,"type":35},"2017-08-01",{"date":163,"type":22},"2027-09-30",{"name":165,"class":42},"Johns Hopkins University",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":23,"phases":175,"briefSummary":176,"conditions":177,"keywords":182,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":52},"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":174,"type":22},7,[25],"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.",[90,30,93,91,178,179,28,180,181],"Amyotrophic Lateral Sclerosis (ALS)","Spinal Cord Injury (Quadraplegia)","Motor Neuron Disease","Brain Stem Stroke",[60,183,184,185,186,63,64,98,65,187,188,189,190,191,192,96,62,193],"Neuralink N1 Implant","Neuralink","Robot","tetraparesis","Amyotrophic lateral sclerosis","chip","brain chip","External device control","Wireless implant","Neuroprosthetics","motor neuron disease","2025-08-11",{"date":196,"type":35},"2025-08-17",{"date":198,"type":35},"2025-07-31",{"date":200,"type":22},"2031-02",{"name":108,"class":109},{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":21},"100463924","wrist-extensor-mep-up-conditioning-for-individuals-with-incomplete-spinal-cord-injury-100463924","NCT05321017","Wrist Extensor MEP Up-conditioning for Individuals With Incomplete Spinal Cord Injury","Can Increasing Motor Evoked Potential Size Improve Upper Extremity Motor Function in Individuals With Incomplete Spinal Cord Injury?","uMEP","Inclusion Criteria:\n\n1. a history of injury to spinal cord at or above C6\n2. neurologically stable (\\>6 mo post SCI)\n3. medical clearance to participate\n4. weak wrist extension at least unilaterally\n5. expectation that current medication will be maintained without change for at least 3 months. Stable use of anti-spasticity medication (e.g., baclofen, diazepam, tizanidine) is accepted. In participants with bilateral wrist extension weakness, the more severely impaired arm is studied.\n\nExclusion Criteria:\n\n1. motoneuron injury\n2. medically unstable condition\n3. cognitive impairment\n4. a history of epileptic seizures\n5. metal implants in the cranium\n6. implanted biomedical device in or above the chest (e.g., a cardiac pacemaker, cochlear implant)\n7. no measurable MEP elicited in the ECR\n8. unable to produce any voluntary ECR EMG activity\n9. extensive use of functional electrical stimulation to the arm on a daily basis\n10. pregnancy (due to changes in posture and potential medical instability).",{"count":145,"type":22},[25],"The purpose of this study is to examine the relationship between common clinical assessments and measurements of the function of brain-spinal cord-muscle connections, and to examine the effects of training a brain-spinal cord-muscle response in individuals with incomplete spinal cord injury. A transcranial magnetic stimulator (TMS) is used for examining brain-to-muscle pathways. This stimulator produces a magnetic field for a very short period of time and indirectly stimulates brain cells with little or no discomfort. The target muscle is the wrist extensor (extensor carpi radialis) muscle that bends the wrist back. It is hypothesized that training the wrist extensor muscle response to transcranial magnetic stimulation will increase the strength of the brain-to-muscle pathway, which will improve the ability to move the arm.\n\nIt is hoped that the results of this training study will help in developing therapy strategies for individuals, promoting better understanding of clinical assessments, and understanding treatments that aim to improve function recovery in people with spinal cord injury (SCI).\n\nThis study requires 30 visits, and each visit will last approximately 1.5 hours.",[214,30],"Spinal Cord Injuries","2025-06-16",{"date":217,"type":35},"2025-06-19",{"date":219,"type":35},"2021-10-12",{"date":221,"type":22},"2026-06-30",{"name":223,"class":42},"Medical University of South Carolina",{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":23,"phases":233,"briefSummary":234,"conditions":235,"keywords":236,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":21},"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":232,"type":22},10,[25],"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.",[90,30,93,91,178,179,28,180,181],[60,183,184,185,186,63,64,98,65,187,188,189,190,191,192,96,62,193],"2025-06-03",{"date":239,"type":35},"2025-06-05",{"date":241,"type":35},"2025-05-09",{"date":243,"type":22},"2027-11",{"name":108,"class":109},{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":17,"minAge":253,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":23,"phases":255,"briefSummary":256,"conditions":257,"keywords":258,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":21},"100569904","can-prime-precise-robotically-implanted-brain-computer-interface-for-the-control-of-external-devices-100569904","NCT06700304","CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices","CAN-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices","CAN-PRIME","Inclusion Criteria:\n\n* Severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) for at least 1 year without improvement, where quadriplegia is defined as having very limited or no hand, wrist, and arm movement and all levels below\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","19 Years",{"count":117,"type":22},[25],"The CAN-PRIME Study is to test the safety and functionality of Neuralink's N1 Implant and R1 Robot in people who have difficulty moving their arms and legs (tetraparesis or tetraplegia). The N1 Implant is a small, wireless device placed in the skull. It connects to tiny threads inserted into the brain by the R1 Robot, which is a machine designed to carefully place these threads. This study will help researchers learn how well the implant and robot work and if they are safe for use.",[90,30,93,91,178,179,28],[60,183,184,185,186,63,64,98,65,187,188,189,190,191,192,96,62],"2025-05-27",{"date":261,"type":35},"2025-05-31",{"date":263,"type":35},"2024-11-20",{"date":265,"type":22},"2030-11-30",{"name":108,"class":109},{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":274,"targetDuration":4,"studyType":23,"phases":275,"briefSummary":276,"conditions":277,"keywords":278,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":290},"100206454","sensory-motor-transformations-in-human-cortex-100206454","NCT01964261","Sensory Motor Transformations in Human Cortex","A Feasibility Study of the Ability of the Neural Prosthetic System 2 to Provide Direct Closed Loop Cortical Control of Extracorporeal Devices Through the Use of Intracortical Microstimulation in Patients With Quadriplegia","Inclusion Criteria:\n\n* High cervical spinal lesion\n* Age 22-65\n* Able to provide informed consent\n* Able to understand and comply with instructions in English\n* Communicate via speech\n* Surgical clearance\n* Life expectancy greater than 12 months\n* Travel up to 60 miles to study locations up to five days per week\n* Caregiver monitor for surgical site complications and behavioral changes on a daily basis\n* Psychosocial support system\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* Previous neurosurgical history affecting parietal lobe function\n* Medical conditions contraindicating surgery and chronic implantation of a medical device\n* Prior cranioplasty\n* Unable to undergo MRI or anticipated need for MRI during study\n* Nursing an infant or unwilling to bottle-feed infant\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\n* Implanted Cardiac Defibrillator, Pacemaker, vagal nerve stimulator, or spinal cord stimulator.\n* Implanted deep brain stimulator (DBS), DBS leads, or cochlear implant.",{"count":145,"type":22},[25],"This research study is being conducted to develop a brain controlled medical device, called a brain-machine interface. The device will provide people with a spinal cord injury some ability to control an external device such as a computer cursor or robotic limb by using their thoughts along with sensory feedback.\n\nDevelopment of a brain-machine interface is very difficult and currently only limited technology exists in this area of neuroscience. Other studies have shown that people with high spinal cord injury still have intact brain areas capable of planning movements and grasps, but are not able to execute the movement plans. The device in this study involves implanting very fine recording electrodes into areas of the brain that are known to create arm movement plans and provide hand grasping information and sense feeling in the hand and fingers. These movement and grasp plans would then normally be sent to other regions of the brain to execute the actual movements. By tying into those pathways and sending the movement plan signals to a computer instead, the investigators can translate the movement plans into actual movements by a computer cursor or robotic limb.\n\nA key part of this study is to electrically stimulate the brain by introducing a small amount of electrical current into the electrodes in the sensory area of the brain. This will result in the sensation of touch in the hand and\u002For fingers. This stimulation to the brain will occur when the robotic limb touches the object, thereby allowing the brain to \"feel\" what the robotic arm is touching.\n\nThe device being used in this study is called the Neuroport Array and is surgically implanted in the brain. This device and the implantation procedure are experimental which means that it has not been approved by the Food and Drug Administration (FDA). One Neuroport Array consists of a small grid of electrodes that will be implanted in brain tissue and a small cable that runs from the electrode grid to a small hourglass-shaped pedestal. This pedestal is designed to be attached to the skull and protrude through the scalp to allow for connection with the computer equipment. The top portion of the pedestal has a protective cover that will be in place when the pedestal is not in use. The top of this pedestal and its protective cover will be visible on the outside of the head. Three Neuroport Arrays and pedestals will be implanted in this study so three of these protective covers will be visible outside of the head. It will be possible to cover these exposed portions of the device with a hat or scarf.\n\nThe investigators hope to learn how safe and effective the Neuroport array plus stimulation is in controlling computer generated images and real world objects, such as a robotic arm, using imagined movements of the arms and hands.",[30],[57,58,279,60,61,62,63,64,65,280,281],"Brain machine interface","stimulation","sensory feedback","2025-05-20",{"date":284,"type":35},"2025-05-22",{"date":286,"type":35},"2013-11-01",{"date":288,"type":22},"2027-01-31",{"name":74,"class":42},4,{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":298,"targetDuration":4,"studyType":23,"phases":299,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":305,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":21},"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":145,"type":22},[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.",[30,302,303,304],"Amputations","Spinal Cord Injuries (SCI)","Brainstem Stroke","NOT_YET_RECRUITING","2025-04-17",{"date":308,"type":35},"2025-04-25",{"date":310,"type":22},"2025-04",{"date":312,"type":22},"2027-04",{"name":314,"class":109},"Shanghai StairMed Technology Co., Ltd."]