[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"paralysis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:paralysis":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,53,81,105,136,164,190,215],{"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":14,"conditions":25,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100633993","functional-outcomes-and-control-using-synchron-bci---australia-100633993",false,"NCT07533903","Functional Outcomes and Control Using Synchron BCI - Australia","Functional Outcomes and Control Using Synchron BCI - Australia (FOCUS-AUS)","FOCUS-AUS","Inclusion Criteria:\n\n1. Able to provide informed consent to participate in the study.\n2. Bilateral upper-limb paresis or Amyotrophic lateral sclerosis (ALS) with bilateral upper limb paresis\n3. The underlying condition causing motor impairment must be refractory to treatment and have been present for a minimum of twelve months.\n4. Aged 21 years or older\n5. Life expectancy greater than 12 months post-implantation\n6. Preserved precentral gyrus assessed using CT\n7. Suitable vascular anatomy assessed using CT venography\n8. Suitable anatomy for subcutaneous pocket creation\n9. Able to undergo anesthesia\n10. Willing and able to comply with investigational requirements, including clinical testing visits and training visits in the home.\n11. Caregiver(s) willing and able to facilitate study visits, including visits at the study site and in the home, and BCI use outside of study visits (e.g. device charging)\n12. Patient and caregiver fluent in English\n13. Suitable home environment for BCI training, including an internet connection\n\nExclusion Criteria:\n\n1. Unrealistic expectations regarding the potential benefits of the device.\n2. Active infection or unexplained fever in the 48 hours prior to informed consent\n3. Major psychiatric disorder that may adversely impact the participant's safety or study compliance, including severe depression, psychotic features, personality disorder, severe emotional lability, or substance abuse.\n4. Dementia or cognitive dysfunction that would impact the participant's ability to participate in study activities.\n5. Active implanted device (e.g., deep brain stimulator, cardiac defibrillator, pacemaker, vagal nerve stimulator, spinal cord stimulator, diaphragmatic pacer, etc.).\n6. Known allergy to patient-contacting materials included in the implanted device\n7. Contraindication to angiographic imaging or iodine contrast media.\n8. History of central venous sinus thrombosis.\n9. Recent history of new venous thromboembolic event (in the 6 months prior to implant) or recurrent history of venous thromboembolic disease\n10. Contraindication to antithrombotic therapy.\n11. Participant is at substantially increased risk of infection, including immunocompromised status, recurrent infection, or poorly controlled diabetes mellitus.\n12. Significant risk of non-healing of the subcutaneous pocket incision, including history of chronic non-healing surgical wounds or poorly controlled diabetes mellitus.\n13. Pregnant or breast feeding.\n14. Patients who are currently enrolled in any other clinical trial that would confound interpretation of safety or effectiveness data or may interfere with the ability to meet study requirements.\n15. Any other disease or disorder that could significantly affect participation in the study. Examples may include corrected vision insufficient for viewing computer screens or hearing insufficient for following verbal instructions, which might impact the participant's ability to participate in BCI training and testing.","ALL","21 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"NA",[26,27,28,29,30,31,32],"Neurologic Disorder","Neurologic Diseases","MND (Motor Neurone DIsease)","Motor Neuron Disease","Motor Neuron Disease, Amyotrophic Lateral Sclerosis","Paralysis Arm","Paralysis",[34,35,36,37,38,39],"ALS","BCI","Brain Computer Interface","MND","Upper Limb Paralysis","Motor Neurone Disease","RECRUITING","2026-06-05",{"date":43,"type":44},"2026-06-09","ACTUAL",{"date":46,"type":44},"2026-05-22",{"date":48,"type":21},"2027-12",{"name":50,"class":51},"Synchron, Inc.","INDUSTRY",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":78,"locationsCount":52},"100488777","nomad-p-kafo-study-100488777","NCT05644522","Nomad P-KAFO Study","Power Forward Study: A Cross-Sector, Multisite Clinical Trial of a Powered Knee-Ankle-Foot Orthosis","Inclusion Criteria:\n\n* Regular and compliant use of a unilateral or bilateral KAFO or SCO or other passive KAFOs for impairment due to neurological or neuromuscular disease, orthopedic disease, or trauma\n* Cognitive ability to understand and follow the study protocol; willingness to provide informed consent\n* Willing to wear and charge an activity monitor for three-months home trials.\n\nExclusion Criteria:\n\n* Flexion contracture in the knee and\u002For hip joint in excess of 15 degrees\n* Non-correctable knee varus\u002Fvalgus in excess of 15 degrees\n* Severe spasticity\n* Inability to stabilize the trunk with or without assistive devices (crutches, canes, etc.)","18 Years","89 Years",{"count":63,"type":21},36,[24],"The goal of this clinical trial is to evaluate the impact of using the Nomad powered KAFO in people who have had a musculoskeletal or neurological injury that has affected their ability to walk. The main questions it aims to answer are to quantify the effectiveness of the Nomad in improving mobility, balance, frequency of falls, and quality of life in individuals with lower-extremity impairments compared to their own brace, over three months of daily home and community use.\n\nParticipants will:\n\n* Wear a sensor that records everyday activities and mobility.\n* Perform measures of mobility and different activities of participation using their own brace.\n* Perform measures of mobility and different activities of participation using the Nomad powered KAFO",[67,68,69,70,71,32],"Cerebrovascular Accident","Post-polio Syndrome","Spinal Cord Injuries","Multiple Sclerosis","Muscular Dystrophy","2026-05-07",{"date":74,"type":44},"2026-05-11",{"date":76,"type":44},"2024-03-01",{"date":48,"type":21},{"name":79,"class":80},"Shirley Ryan AbilityLab","OTHER",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":4},"100633518","postoperative-neurological-recovery-and-risk-factor-analysis-in-patients-with-paralysis-due-to-spinal-metastases-100633518","NCT07527728","Postoperative Neurological Recovery and Risk Factor Analysis in Patients With Paralysis Due to Spinal Metastases","Inclusion Criteria:\n\n1. Age between 18 and 80 years at the time of enrollment.\n2. Clinical diagnosis of spinal metastases with resulting motor paralysis.\n3. Scheduled for surgical decompression and\u002For spinal stabilization.\n4. Medically fit to undergo surgery as determined by preoperative evaluation.\n5. Ability to understand the study and provide written informed consent.\n6. Willingness and ability to complete neurological and functional follow-up assessments.\n\nExclusion Criteria:\n\n1. Medically unfit for surgery due to unstable comorbidities or poor general condition.\n2. Pregnant or breastfeeding at the time of enrollment.\n3. Significant cognitive impairment or psychiatric illness that interferes with informed consent or study participation.\n4. Expected difficulty in completing follow-up assessments or anticipated loss to follow-up.\n5. Missing critical baseline or follow-up data relevant to study endpoints.",{"count":88,"type":21},150,"OBSERVATIONAL","Metastatic spinal tumors represent a common and devastating complication in patients with advanced solid malignancies. Up to 40% of cancer patients may develop spinal metastases during the course of their disease, often resulting in intractable pain, neurological deficits, and spinal instability. One of the most serious consequences is motor paralysis caused by metastatic epidural spinal cord compression (MESCC), which can severely impair patients' quality of life and limit their ability to receive subsequent anti-tumor therapy. Although surgical decompression and stabilization are recognized as effective strategies for relieving spinal cord compression and restoring spinal integrity, the neurological prognosis for patients who present with paralysis remains uncertain and heterogeneous.\n\nThis prospective, single-center, observational cohort study aims to evaluate the early and mid-term neurological recovery trajectories in patients with paralysis caused by spinal metastases, and to identify perioperative clinical factors associated with favorable or poor functional outcomes. The study will be conducted at Shanghai Changzheng Hospital, a tertiary care academic center with extensive experience in spinal oncology and multidisciplinary cancer care.\n\nThe investigators plan to consecutively enroll adult patients (aged 18-80) diagnosed with spinal metastatic tumors who present with motor paralysis and are deemed appropriate surgical candidates by a multidisciplinary tumor board. Participants will undergo surgical decompression and stabilization based on individualized tumor location and spinal instability. The study does not involve any investigational drug or device. All surgical procedures and adjuvant treatments (such as radiotherapy or systemic therapy) will be delivered according to standard of care.\n\nPreoperative evaluations will include spinal imaging (MRI, CT), neurological scoring using the ASIA Impairment Scale, and assessments of systemic condition, spinal instability (SINS), and epidural compression severity (ESCC scale). Participants will be followed at 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery to monitor neurological recovery, pain control, bowel\u002Fbladder function, treatment complications, and survival.\n\nThe primary outcome is the improvement in motor function at 1 month postoperatively, quantified by changes in ASIA motor scores. Secondary outcomes include longer-term neurological recovery, progression of bowel and bladder function, quality of life, complication rates, disease progression, and survival outcomes. Additional analyses will explore the impact of variables such as timing of surgery, tumor histology, location of compression, and performance status on recovery.\n\nThis study will employ both univariate and multivariate statistical methods to identify independent predictors of postoperative neurological improvement, using logistic regression and time-to-event analyses. A total of 150 participants will be recruited, based on power analysis accounting for key covariates and anticipated dropout rates.\n\nThrough this prospective clinical registry and analysis, the study aims to provide evidence-based data to guide clinical decision-making in the management of MESCC with paralysis. The findings will help inform surgical indications, optimize timing of intervention, and support the development of prognostic tools for patient counseling. Given the limited life expectancy of many patients with advanced cancer, maximizing early neurological recovery may directly impact patient autonomy, eligibility for systemic therapy, and overall quality of life.",[92,93,32,94],"Metastatic Spinal Tumors","Spinal Cord Compression","Neurological Deficits","NOT_YET_RECRUITING","2026-04-09",{"date":98,"type":44},"2026-04-14",{"date":100,"type":21},"2026-05-01",{"date":102,"type":21},"2028-06-30",{"name":104,"class":80},"Shanghai Changzheng Hospital",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":17,"minAge":60,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":117,"conditions":118,"keywords":124,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":134,"locationsCount":52},"100420510","early-phase-1-chronic-transcutaneous-stimulation-to-promote-motor-function-and-recovery-in-individuals-with-paralysis-or-paresis-100420510","NCT04755699","Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis","Healthy Volunteer Inclusion Criteria:\n\n* Individuals between 18 and 75 years of age\n* Individuals without physical disabilities or conditions\u002Fdiseases that may make them incapable of completing the physical study tasks or otherwise places them at a greater risk of harm\n* Individuals that are considered English Proficient due to the study requirements to follow verbal commands during sessions\n* Individuals that are able to comprehend the study goals and procedures, and are able to provide informed consent for participation\n* Individuals that are willing and able to visit the study center for study procedures, which may be up to 5 sessions a week for up to 1 year (at least 2 months) at up to 4 hours per session\n\nStroke and Spinal Cord Injury Participant Inclusion Criteria:\n\n* Individuals between 18 and 75 years of age\n* Individuals with a limited ability to use at least one hand due to a spinal cord injury or stroke\n* Individuals that are at least six months from their initial stroke or one year from their initial spinal cord injury\n* Individuals that are considered English Proficient due to the study requirements to follow verbal commands during testing sessions\n* Individuals that are able to comprehend the study goals and procedures, and are able to provide informed consent for participation\n* Individuals that are willing and able to visit the study center for study procedures, which may be up to 5 sessions a week for up to 1 year (at least 2 months) at up to 4 hours per session\n\nBrain or Nerve Injury Participant Inclusion Criteria:\n\n* Individuals between 18 and 75 years of age\n* Individuals with a limited ability or no ability to use at least one limb due to a brain or nerve injury such as a traumatic brain injury, brachial plexus injury, peripheral nerve damage, or Parkinson's Disease.\n* Individuals that are considered English Proficient due to the study requirements to follow verbal commands during testing sessions\n* Individuals that are able to comprehend the study goals and procedures, and are able to provide informed consent for participation\n* Individuals that are willing and able to visit the study center for study procedures, which may be up to 5 sessions a week for up to 1 year (at least 2 months) at up to 4 hours per session\n\nExclusion Criteria for All Study Participants:\n\n* Individuals participating in another study that may affect the conduct or results of this study\n* Individuals having or exhibiting any of the following, as specified by self-report:\n\n  * Stage III-IV pressure ulcers that adversely interfere with study involvement (i.e., pressure ulcer on the extremity of interest or prohibits extended bouts of sitting)\n  * History of epilepsy\n  * Chronically-implanted electronic medical device (e.g. deep brain stimulator, epidural stimulator, cardiac pacemaker, vagus nerve stimulator, or other)\n  * Abnormalities of the arms\u002Fhands, legs\u002Ffeet, or spinal column that would prevent electrical stimulation\n  * Ventilator dependence\n  * History of serious mood or thought disorder\n  * Uncontrolled autonomic dysreflexia\n  * Severe spasticity in extremities of interest that are uncontrolled by pharmacological methods or prevents electrical stimulation\n  * Botulinum toxin injections to the extremity of interest within 3 months\n  * Presence of active cancer at or near the areas of transcutaneous stimulation\n  * History of heart or kidney disease\n  * History of additional neurologic diseases (e.g., multiple strokes, multiple sclerosis, etc.)\n  * Presence of other serious infections, diseases, or disorders that could affect ability to participate in this study (e.g., uncontrolled hypertension, uncontrolled diabetes, rheumatic disease, peripheral neuropathy, HIV or AIDS, etc.)\n* Individuals with a substance abuse (alcoholism or other) problem\n* Pregnant women\n* Prisoners",true,"75 Years",{"count":114,"type":21},64,[116],"EARLY_PHASE1","This is an early feasibility trial to determine whether transcutaneous neuromuscular electrical stimulation, with or without transcutaneous spinal cord stimulation, using an investigational neurostimulation device improves functional arm\u002Fhand movements in individuals with paralysis or paresis due to a spinal cord injury or stroke and improves functional arm\u002Fhand or leg\u002Ffoot movements in individuals with paralysis or paresis due to other brain or nerve injuries.\n\nIn this study, eligible individuals that agree to participate will be asked to attend up to 5 study sessions a week for 1 year (depending on participant availability), with each session lasting up to 4 hours. At the first study session, participants will have their demographic information collected, vital signs assessed, and have measurements performed of their limbs and torso, as appropriate. They will also undergo clinical evaluations and tests to assess their current functional movement and sensation capabilities.\n\nDuring subsequent study sessions, participants will undergo many tasks designed to improve functional movements in paralyzed limbs. Specifically, participants will receive neuromuscular electrical stimulation to the limb(s) and\u002For electrical stimulation to the spinal cord to evoke specified movements. The stimulation parameters and locations on the spinal column and\u002For limb(s) that evoke specific movements will be noted. The movements will be assessed with visual inspection, electromyography, and\u002For sensors.\n\nThe clinical evaluations and tests to assess functional movement and sensation capabilities will be repeated throughout the study and at the last study session to assess for functional improvements compared to the first study session. Upon completion of these study sessions, the individual's participation in the study is considered complete.",[119,120,121,32,122,123],"Healthy Volunteers","Spinal Cord Injury","Stroke","Paresis","Neurological Injury",[125,126,127],"Neuromuscular Stimulation","Spinal Cord Stimulation","Physical Medicine and Rehabilitation","2026-03-09",{"date":130,"type":44},"2026-03-11",{"date":132,"type":44},"2020-12-02",{"date":102,"type":21},{"name":135,"class":80},"Northwell Health",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":52},"100169050","a-neuroprosthesis-for-seated-posture-and-balance-100169050","NCT01474148","A Neuroprosthesis for Seated Posture and Balance","Trunk Protocol","Inclusion Criteria:\n\n* C4-T12\n* ASIA Scale A through C\n* Time post injury greater than 6 months\n* Innervated and excitable trunk and pelvis musculature\n* Absence of acute or chronic psychological problems or chemical dependency\n* Range of motion within normal limits\n* Controlled spasticity and absence of hip flexion and adduction spasm\n* Height and weight within normal limits\n* No history of balance problems or spontaneous falls\n* No history of spontaneous fracture or evidence low bone density\n* No acute orthopaedic problems\n* No acute medical complications\n* Adequate social support and stability\n* Able to speak and read English\n\nExclusion Criteria:\n\n* Pregnancy\n* Non-English speaking",{"count":20,"type":21},[24],"The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.",[120,32,147,148],"Tetraplegia","Paraplegia",[150,151,152,153],"paraplegia","tetraplegia","Spinal cord injured","FES","2025-10-23",{"date":156,"type":44},"2025-10-27",{"date":158,"type":44},"2011-11-30",{"date":160,"type":21},"2027-01-31",{"name":162,"class":163},"VA Office of Research and Development","FED",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":189},"100446509","operant-conditioning-of-spinal-reflexes-training-system--reflex-operant-down-conditioning-100446509","NCT05094362","Operant Conditioning of Spinal Reflexes Training System--Reflex Operant Down Conditioning","Operant Conditioning of Spinal Reflexes to Enhance Motor Function Recovery After Spinal Cord Injury","Inclusion Criteria:\n\n1. a clinically stable spinal cord injury (above T11) that occurred at least one year previously\n2. the ability to ambulate at least 10 m with or without an assistive device (i.e., walker, crutches, or cane, not parallel bars) within 100 sec (those with 10-meter walking time \\>100 sec are excluded because it is unlikely that they are able to participate in and complete our planned locomotion evaluation procedures)\n3. clinical signs of spasticity in the plantarflexor muscles at least unilaterally (i.e., hyperreactivity to Achilles tendon tap, and increased muscle tone, score \\>1 on Modified Ashworth scale)\n4. spastic hyperreflexia reflected in exaggerated H-reflex\n5. functionally and medically stable for at least 3 months\n6. medical clearance to participate\n7. reasonable expectation that current medications (including antispasticity medication such as baclofen, diazepam, and tizanidine) will not change over the conditioning period. Each participant's medication and dosage will be monitored and recorded throughout the study. Once enrolled, the subject will remain enrolled even if medication changes. (Because only neurologically stable subjects will enter this study, medication changes will be unlikely.)\n\nExclusion Criteria:\n\n1. motoneuron injury;\n2. a cardiac condition (history of myocardial infarct, pacemaker use, etc.)\n3. an unstable medical condition\n4. a pre-existing or confounding neurological condition (e.g., history of Multiple Sclerosis (MS), Traumatic Brain Injury (TBI), Stroke, Parkinson's disease)\n5. a condition that prevents lower extremity mobility testing or weight bearing (e.g. fracture, severe sprain\u002Fstrain, botox muscular injection) (orthotic knee hyperextension is not excluded; in severe cases of knee hyperextension, the brace can be worn during the study sessions)\n6. a cognitive impairment that precludes giving informed consent (e.g., severe intellectual disability)\n7. use of a functional electrical stimulation (FES) foot-drop stimulator or an FES bicycle on a daily basis (FES applied to the arm is acceptable)\n8. deep vein thrombosis within the past 6 months\n9. depression (due to potential interference of anti-depressant medication with the intervention and possible reduced participation reliability)\n10. pregnancy (due to expected changes in weight and posture and potentially unstable medical condition).",{"count":172,"type":21},25,[24],"The purpose of this study is to validate the capacity of a reflex training system to change the size of the targeted reflex. For this, the researchers are recruiting 25 individuals with chronic incomplete SCI who have spasticity in the leg to participate in the reflex training procedure. The study involves approximately 45 visits with a total study duration of about 6 months.",[69,123,32,176],"Spasticity, Muscle",[178,179],"Neuroplasticity","Spinal Reflex","2025-09-05",{"date":182,"type":44},"2025-09-09",{"date":184,"type":44},"2023-08-23",{"date":186,"type":21},"2026-12-31",{"name":188,"class":80},"Medical University of South Carolina",2,{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":112,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":199,"briefSummary":200,"conditions":201,"keywords":202,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":189},"100104456","evaluation-of-an-advanced-lower-extremity-neuroprostheses-100104456","NCT00623389","Evaluation of an Advanced Lower Extremity Neuroprostheses","Evaluation of Advanced Lower Extremity Neuroprostheses","LE-IST","Phase I Inclusion Criteria\n\n1. Skeletal maturity and ability to sign informed consent (\\>18 years)\n2. Non-ventilator dependent paralysis resulting from injuries such as: mid cervical\u002Fthoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and\u002For lower limbs\n3. Innervated and excitable lower extremity and trunk musculature\n4. Adequate social support and stability\n5. Willingness to comply with follow-up procedures\n\nPhase I Exclusion Criteria\n\n1. Non-English speaking\n2. Females who are pregnant\n3. Current pressure injuries that would be exacerbated by study activities\n4. Severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would interfere with study activities\n5. History of spontaneous fractures or other evidence of excessively low bone density\n6. History of vestibular dysfunction, balance problems, or spontaneous falls\n7. Acute and or\u002Funtreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture.",{"count":20,"type":21},[24],"The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate exercise, standing, stepping and\u002For balance in people with various degrees of paralysis.",[69,121,32,147,148],[203,204,205,121,148,147],"Neurologic disorders","Rare disease","Spinal cord injuries","2025-06-12",{"date":208,"type":44},"2025-06-15",{"date":210,"type":44},"2018-06-01",{"date":212,"type":21},"2027-12-31",{"name":214,"class":80},"Case Western Reserve University",{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":17,"minAge":222,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":240},"100349236","awareness-detection-and-communication-in-disorders-of-consciousness-100349236","NCT03827187","Awareness Detection and Communication in Disorders of Consciousness","EEG Based Awareness Detection and Communication in Prolonged Disorders of Consciousness and Physical Disability","Study 1 - Initial assessment\u002Fscreening\n\nInclusion Criteria:\n\n* Disorder of consciousness or low awareness state diagnosis ranging from unclear diagnosis in low awareness states, vegetative state and minimally conscious diagnosis. Those with locked in syndrome \u002F completed locked in syndrome resulting from injury or disease e.g., motor neuron disease who do not have health problems that would preclude them from participating may be assessed but considered as a separate cohort to those with low awareness states.\n* acute, post-acute patients where appropriate\n\nExclusion Criteria:\n\n* Participants with brain related diseases or illnesses (e.g., progressive neurological condition or uncontrolled epilepsy) or suffer from pain (these may adversely affect the brain data produced) and are deemed to be unsuitable for the trials by clinical teams.\n* Current consumption of medications that cause excessive fatigue or adversely affect cognitive functioning\n* Where English is not the individual's first language\n* Participant with excessive uncontrollable arm or head movement or teeth grinding as EEG signal quality will be degraded significantly.\n\nStudy 2 - BCI training\n\nInclusion Criteria:\n\n\\- Those identified in study 1 to have a level of awareness based on observed appropriate brain activations and\u002For those who have known awareness but are target groups for movement independent assistive devices and technologies controlled using a brain-computer interface.\n\nExclusion Criteria:\n\n\\- Participants who have shown no active brain responses in study 1 where the difference between baseline","10 Years","80 Years",{"count":225,"type":21},30,[24],"STUDY OVERVIEW Brain injury can result in a loss of consciousness or awareness, to varying degrees. Some injuries are mild and cause relatively minor changes in consciousness. However, in severe cases a person can be left in a state where they are \"awake\" but unaware, which is called unresponsive wakefulness syndrome (UWS, previously known as a vegetative state). Up to 43% of patients with a UWS diagnosis, regain some conscious awareness, and are then reclassified as minimally conscious after further assessment by clinical experts. Many of those in the minimally conscious state (MCS) and all with unresponsive wakefulness syndrome (UWS) are incapable of providing any, or consistent, overt motor responses and therefore, in some cases, existing measures of consciousness are not able to provide an accurate assessment. Furthermore, patients with locked-in syndrome (LIS), which is not a disorder of consciousness as patients are wholly aware, also, struggle to produce overt motor responses due to paralysis and anarthria, leading to long delays in accurate diagnoses using current measures to determine levels of consciousness and awareness. There is evidence that LIS patients, and a subset of patients with prolonged disorders of consciousness (DoC), can imagine movement (such as imagining lifting a heavy weight with their right arm) when given instructions presented either auditorily or visually - and the pattern of brain activity that they produce when imagining these movements, can be recorded using a method known as electroencephalography (or EEG). With these findings, the investigators have gathered evidence that EEG-based bedside detection of conscious awareness is possible using Brain- Computer Interface (BCI) technology - whereby a computer programme translates information from the users EEG-recorded patterns of activity, to computer commands that allow the user to interact via a user interface. The BCI system for the current study employs three possible imagined movement combinations for a two-class movement classification; left- vs right-arm, right-arm vs feet, and left-arm vs feet. Participants are trained, using real-time feedback on their performance, to use one of these combinations of imagined movement to respond to 'yes' or 'no' answer questions in the Q\\&A sessions, by imagining one movement for 'yes' and the other for 'no'. A single combination of movements is chosen for each participant at the outset, and this participant-specific combination is used throughout their sessions. The study comprises three phases. The assessment Phase I (sessions 1-2) is to determine if the patient can imagine movements and produce detectable modulation in sensorimotor rhythms and thus is responding to instructions. Phase II (sessions 3-6) involves motor-imagery (MI) -BCI training with neurofeedback to facilitate learning of brain activity modulation; Phase III (sessions 7-10) assesses patients' MI-BCI response to closed questions, categorized to assess biographical, numerical, logical, and situational awareness. The present study augments the evidence of the efficacy for EEG-based BCI technology as an objective movement-independent diagnostic tool for the assessment of, and distinction between, PDoC and LIS patients.",[229,32,29,121,230],"Disorder of Consciousness","Physical Disability","2024-12-09",{"date":233,"type":44},"2024-12-13",{"date":235,"type":44},"2022-02-08",{"date":237,"type":21},"2026-08",{"name":239,"class":80},"University of Ulster",18]