[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spinal-cord-injury-quadraplegia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spinal-cord-injury-quadraplegia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,58,110,131,154],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100620746","upper-limb-rehabilitation-using-non-invasive-spinal-cord-stimulation-100620746",false,"NCT07361627","Upper Limb Rehabilitation Using Non-invasive Spinal Cord Stimulation","Improving Upper Limb Motor Control With Spinal Stimulation","CIME_upperlimb","Inclusion Criteria:\n\n* quadraplegic participants with a subacute spinal cord injury (sSCI), defined as the stage of spinal cord damage occurring between 1 week and 6 months post-injury, that fall within the period of at least one year post-injury\n* 16 years old or above\n* have a lesion between above T2\n* residual upper limb movement\n* have injury level according to ASIA A to D\n* hospitalized in the hospital linked with the research center at Gingras Lindsay Rehabilitation Institute of Montreal, 6300 Darlington, Montreal\n* can provide informed consent (no severe cognitive deficits by MoCA)\n* be able to follow instructions in French or English\n\nExclusion Criteria:\n\n* have a pacemaker\n* have active cancer on stimulation site or metastatic cancer\n* have unstable health conditions\n* have unhealed wound, scar or pain which makes positioning of the electrodes impossible\n* participants with specific contraindications to TMS (epilepsy, non-union cranial fracture and increased intracranial pressure) will be able to participate in the study, but will not receive TMS","ALL","16 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this RCT study is to evaluate if combining activity-based therapy (ABT) with transcutaneous spinal cord stimulation (tSCS) can improve recovery of arm and hand movement in people with cervical spinal cord injury (SCI). As secondary aims, the study will also investigate at how this combination approach affects the cortical changes in the somatosensory and motor areas of the brain, as well as in the spinal cord and whether it helps participants use their arms more in daily life.\n\nThe main questions relevant to this study are:\n\n1. Can the combination of ABT + tSCS improve motor and sensory functions of the arms and hands more than ABT alone during the sub-acute stage after SCI?\n2. Does ABT + tSCS induce neuroplasticity, that is, changes in the brain and spinal cord activity linked to motor and sensory functions?\n3. Do participants who receive ABT + tSCS report greater use of their arms in daily activities compared to those who receive ABT only?\n\nIn this study, participants will:\n\n* Receive either ABT + tSCS or ABT + sham stimulation (a low-intensity current that does not facilitate the movements)\n* Take part in 20 training sessions over 6-8 weeks (3 times per week, 45 min of active training each). During this, they will perform strengthening, task-based training, and mental imagery exercises with a therapist.\n* Complete clinical tests and neurophysiological assessments (transspinal electrical stimulation, electroencephalography and transcranial magnetic stimulation) at three time points-- at the start, after training, and one month later to measure recovery and brain activity changes.\n\nResearchers will compare the assessment outcomes across the three time points.",[27,28,29],"Spinal Cord Injury Cervical","Spinal Cord Injury, Acute","Spinal Cord Injury (Quadraplegia)",[31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Spinal cord injury","Sub-acute","Neuromodulation","transcutaneous Spinal Cord Stimulation","Activity-based therapy","Upper extremity motor score","Rehabilitation","Electroencephalography","EEG","Somatosensory evoked potential","Transcranial Magnetic Stimulation","Motor evoked potential","Clinical assessment","Neuroplasticity","NOT_YET_RECRUITING","2026-02-27",{"date":48,"type":49},"2026-03-02","ACTUAL",{"date":51,"type":21},"2026-04-01",{"date":53,"type":21},"2028-08-09",{"name":55,"class":56},"Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal","OTHER",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":17,"minAge":65,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":68,"briefSummary":69,"conditions":70,"keywords":79,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":109},"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","18 Years",{"count":67,"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.",[71,72,73,74,75,29,76,77,78],"Tetraplegia\u002FTetraparesis","Quadriplegia","Quadriplegia\u002FTetraplegia","Cervical Spinal Cord Injury","Amyotrophic Lateral Sclerosis (ALS)","Spinal Cord Injury","Motor Neuron Disease","Brain Stem Stroke",[80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97],"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","RECRUITING","2025-08-11",{"date":101,"type":49},"2025-08-17",{"date":103,"type":49},"2025-07-31",{"date":105,"type":21},"2031-02",{"name":107,"class":108},"Neuralink Corp","INDUSTRY",2,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":65,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":57},"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":118,"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.",[71,72,73,74,75,29,76,77,78],[80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97],"2025-06-03",{"date":125,"type":49},"2025-06-05",{"date":127,"type":49},"2025-05-09",{"date":129,"type":21},"2027-11",{"name":107,"class":108},{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":139,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":57},"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":141,"type":21},6,[24],"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.",[71,72,73,74,75,29,76],[80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96],"2025-05-27",{"date":148,"type":49},"2025-05-31",{"date":150,"type":49},"2024-11-20",{"date":152,"type":21},"2030-11-30",{"name":107,"class":108},{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":17,"minAge":162,"maxAge":163,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":167,"conditions":168,"keywords":176,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":57},"100588304","bci-assisted-scs-exs-for-gait-optimization-100588304","NCT06939660","BCI-Assisted SCS-EXS for Gait Optimization","Spatiotemporal Spinal Cord Stimulation Based on Implantable Brain-machine Interfaces and Exoskeletons for Spinal Cord Injury (BASEGO)","BASEGO","Inclusion Criteria:\n\n* Age 14-65 years, any gender.\n* Clinical diagnosis of spinal cord injury (SCI) due to trauma, inflammation, tumor, vascular disease, or iatrogenic factors, confirmed by medical history, physical examination, and ancillary tests, resulting in lower limb motor dysfunction.\n* SCI diagnosed ≥6 months prior, with ≥1 month of continuous conventional rehabilitation (e.g., physical therapy, acupuncture, hydrotherapy, ≥3 hours daily) without significant improvement in motor function in the past 2 months.\n* ASIA Impairment Scale (AIS) grade A, B, or C based on the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).\n* Good general health with a life expectancy ≥12 months.\n* Mini-Mental State Examination (MMSE) score ≥22.\n* Educational attainment of secondary school or above.\n* Willingness to participate, provide informed consent, and comply with study follow-up.\n\nExclusion Criteria:\n\n* Presence of diseases other than spinal cord injury (SCI) that affect lower limb motor function, including brain diseases (e.g., brain tumor, stroke), lower limb vascular diseases (e.g., lower limb vascular occlusion), peripheral nerve diseases, or lower limb bone diseases (e.g., osteoarthritis, joint contracture).\n* Requires continuous medical interventions (e.g., tracheal intubation, nasogastric feeding) to maintain critical physiological functions (e.g., heartbeat, respiration, swallowing).\n* Congenital or acquired structural abnormalities of the lower limb bones or muscles.\n* Presence of surgical contraindications (e.g., anesthesia-related adverse reactions, coagulation risks, or surgeon's determination of unsuitability for surgery).\n* Presence of active implantable devices except for SCS or BCI devices (e.g., pacemakers, defibrillators, drug infusion pumps, cochlear implants, sacral nerve stimulators).\n* Unable to receive implantable devices due to other disease treatments or investigations, or requires magnetic resonance imaging (MRI) during the device implantation period.\n* MRI shows structural damage \\>50% in motor function areas (precentral and postcentral gyri, ventromedial sensorimotor areas, mid temporal lobe, Broca's area, Wernicke's area, Geschwind's area), or DTI shows damage \\>50% in the posterior limb of the internal capsule.\n* Severe cardiovascular disease: Above level II myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QTc interval ≥450 ms in men, ≥470 ms in women), level III-IV heart failure (NYHA classification), or echocardiography showing LVEF \\\u003C50%.\n* Coagulation abnormalities (INR \\>1.5 ULN, PT \\>ULN +4 s, or APTT \\>1.5 ULN), hemorrhagic tendency, or undergoing thrombolytic or anticoagulant therapy.\n* Severe infections within 4 weeks before surgery (requiring IV antibiotics, antifungals, or antivirals) or lumbar soft tissue infections, or unexplained fever \\>38.5℃ during screening or before surgery.\n* HIV infection, acquired immunodeficiency syndrome (AIDS), active tuberculosis, active hepatitis B (HBV DNA ≥500 IU\u002Fml), hepatitis C (positive HCV antibody and detectable HCV-RNA), or co-infection of hepatitis B and C.\n\nSevere cerebrovascular events (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, or pulmonary embolism within 12 months before enrollment.\n\n* Metastatic malignancies or untreated malignant tumors.\n* Major surgery or severe traumatic injuries, fractures, or ulcers within 4 weeks before enrollment.\n* Addictive habits such as drug abuse or alcoholism.\n* History of psychotropic drug abuse that is not controllable or presence of mental disorders, including major psychiatric illnesses (e.g., depression \\[BDI score \\>20\\], anxiety, obsessive-compulsive disorder, schizophrenia, autism, chronic sleep disorders, consciousness disorders).\n* Pregnant, breastfeeding, planning to conceive, or women of childbearing potential without reliable contraception.\n* Participation in other clinical trials within the past month.\n* Cognitive impairments or poor compliance from subjects, family members, or caregivers, or inability to complete at least 12 months of follow-up and rehabilitation training.\n* Other conditions that increase the risk of study participation or device use, as determined by the investigator.","14 Years","65 Years",{"count":165,"type":21},3,[24],"The goal of this clinical trial is to evaluate the safety and technical feasibility of a novel brain-machine interface (BCI)-assisted spinal cord stimulation (SCS) and exoskeleton (EXS) system in patients with spinal cord injury (SCI). The primary aim is to determine whether the BCI-SCS-EXS system can safely and effectively improve lower limb motor function and quality of life in individuals with chronic SCI.\n\nParticipant Population:\n\nAdults aged 14-65 years (sex\u002Fgender not limited). Patients with chronic SCI (≥6 months post-injury) classified as ASIA A, B, or C.\n\nIndividuals with stable health status, MMSE ≥22, and secondary education or above.\n\nPrimary Questions:\n\n1. Is the BCI-SCS-EXS system safe and technically feasible for SCI rehabilitation?\n2. Does the system improve lower limb motor function and quality of life in SCI patients?\n\nInterventions:\n\nParticipants will undergo the following procedures:\n\nPhase I (Implantation):\n\nBCI implantation: ECoG electrodes placed over the motor cortex to decode lower limb movement intent.\n\nSCS electrode implantation: 5-6-5 paddle electrodes at T11-L2 for targeted spinal cord stimulation.\n\nPhase II (System Calibration):\n\nBCI-SCS synchronization: Calibration of decoded motor intent to trigger SCS parameters.\n\nSCS-EXO synchronization: Integration of SCS pulses with exoskeleton-assisted gait training.\n\nPhase III (Rehabilitation):\n\nDaily BCI-SCS-EXS training sessions (60 minutes, 5 times\u002Fweek for 1 year). Adaptive adjustments to stimulation parameters and exoskeleton support based on performance.\n\nRemote monitoring of device performance and emergency intervention for technical issues.\n\nOutcome Measures:\n\nPrimary: Safety (adverse events, device performance, synchronization metrics). Secondary: Efficacy (motor function, neurophysiological function, quality of life).\n\nEthics and Safety:\n\nInformed consent will be obtained from all participants. Adverse events will be monitored and reported according to CTCAE 5.0 guidelines.\n\nParticipant confidentiality will be strictly maintained. This study will provide foundational evidence for the safety and feasibility of the BCI-SCS-EXO system, paving the way for future randomized controlled trials in SCI rehabilitation.",[169,170,76,27,171,29,172,173,174,175],"Spinal Cord Injuries (SCI)","Spinal Cord Injury, Chronic","Spinal Cord Injury Thoracic","Motor Impairment","Motor Deficits","Gait Training","Gait Impairment",[177,178,179,37,31,180,181,182,183,184,185,186],"Brain-computer interface","Spianl cord stimulation","Exoskeleton","Motor dysfunction","BCI","Brain-spinal interface","BSI","Brain-machine interface","Gait training","Neural plasticity","2025-05-14",{"date":189,"type":49},"2025-05-20",{"date":191,"type":49},"2025-04-23",{"date":193,"type":21},"2027-04-30",{"name":195,"class":56},"Xuanwu Hospital, Beijing"]