[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tetraplegia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tetraplegia":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,46,74,101,136,173,198,225,251,272,300,327,350,372,396,421,447,472,498,518],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100555426","feasibility-of-the-braingate2-neural-interface-system-in-persons-with-tetraplegia-bg-tablet-01-100555426",false,"NCT06511934","Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)","Intuitive, Complete Neural Control of Tablet Computers for Communication","BG-Tablet-01","Inclusion Criteria:\n\n* Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders\n* Complete or incomplete tetraplegia (quadriplegia)\n* Must live within a three-hour drive of the Study site\n* Prior enrollment in BrainGate2 clinical trial (NCT00912041)\n\nExclusion Criteria:\n\n* Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses\n* Chronic oral or intravenous steroids or immunosuppressive therapy\n* Other serious disease or disorder that could seriously affect ability to participate in the study\n\n(There are additional exclusion criteria)","ALL","18 Years","80 Years",{"count":21,"type":22},6,"ESTIMATED","INTERVENTIONAL",[25],"NA","People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals related to movement, and to further develop an intracortical brain-computer interface (iBCI) that could restore rapid and intuitive use of communication apps on tablet computers by people with paralysis.",[28,29,30,31,32],"Brainstem Stroke","ALS","Tetraplegia","Spinal Cord Injuries","Cervical Spinal Cord Injury","RECRUITING","2026-06-22",{"date":36,"type":37},"2026-06-25","ACTUAL",{"date":39,"type":37},"2024-07-22",{"date":41,"type":22},"2027-07-30",{"name":43,"class":44},"Leigh R. Hochberg, MD, PhD.","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100494899","feasibility-of-the-braingate2-neural-interface-system-in-persons-with-tetraplegia-100494899","NCT05724173","Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia","Single Neuron Population Dynamics in Human Speech Motor Cortex for a Speech Prosthesis","BG-Speech-01","Inclusion Criteria:\n\n* Between 18 and 80 years of age.\n* Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases.\n* Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months.\n* Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.\n\nExclusion Criteria:\n\n* Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses\n* Chronic oral or intravenous steroids or immunosuppressive therapy\n* Other serious disease or disorder that could seriously affect ability to participate in the study\n\n(There are additional exclusion criteria)",{"count":55,"type":22},3,[25],"The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.",[59,60,30,31,61,62,63,64],"Anarthria","Dysarthria","Amyotrophic Lateral Sclerosis","Brain Stem Infarctions","Locked in Syndrome","Muscular Dystrophies","2026-05-29",{"date":67,"type":37},"2026-06-02",{"date":69,"type":37},"2023-10-18",{"date":71,"type":22},"2027-07-31",{"name":43,"class":44},2,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":57,"conditions":84,"keywords":86,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":21},"100126292","braingate2-feasibility-study-of-an-intracortical-neural-interface-system-for-persons-with-tetraplegia-100126292","NCT00912041","BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia","BrainGate2","Inclusion Criteria:\n\n* Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders\n* Complete or incomplete tetraplegia (quadriplegia)\n* Must live within a three-hour drive of the Study site\n* (There are additional inclusion criteria)\n\nExclusion Criteria:\n\n* Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses\n* Chronic oral or intravenous steroids or immunosuppressive therapy\n* Other serious disease or disorder that could seriously affect ability to participate in the study\n* (There are additional exclusion criteria)",{"count":82,"type":22},27,[25],[30,31,61,62,63,85],"Muscular Dystrophy",[87,88,89,90,91,92],"Brain computer interface","Assistive device","Environmental control","Communication device","quadriplegia","tetraplegia","2026-05-28",{"date":95,"type":37},"2026-06-01",{"date":97,"type":4},"2009-05",{"date":99,"type":22},"2038-12",{"name":43,"class":44},{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":108,"targetDuration":110,"studyType":111,"phases":4,"briefSummary":112,"conditions":113,"keywords":120,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100488290","nerve-transfer-surgery-to-restore-upper-limb-function-after-cervical-spinal-cord-injury-100488290","NCT05638191","Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury","Inclusion Criteria:\n\n* Traumatic, motor-complete cervical SCI (AIS A or B)\n* Male or female, ages 18-70\n* Consent and plan to undergo nerve transfer to restore grasp function in at least one limb\n* Motor grade 4-5 at C5\n* Motor grade 0-1 at C8\u002FT1\n* Injury duration within 6 months at the time of surgery\n* English-speaking and cognitively intact\n* Able to provide informed written consent\n* Able to attend and comply with the testing protocols\n\nExclusion Criteria:\n\n* Inability or unwillingness to participate in post-operative rehabilitation (in person or virtual)\n* Secondary complication of SCI (e.g., intractable neuropathic pain, edema, contracture) or major medical comorbidity (e.g., traumatic brain injury) that would independently influence response to surgery or ability to participate in rehabilitation","70 Years",{"count":109,"type":22},40,"2 Years","OBSERVATIONAL","The goal of this prospective, open-label cohort study is to assess functional outcomes in individuals with cervical spinal cord injury who have undergone nerve transfer surgery to restore upper limb function. The main questions it aims to answer are:\n\n* Does nerve transfer improve hand function in individuals with cervical spinal cord injury?\n* What factors are associated with functional improvement following nerve transfer? Researchers will compare functional outcomes at 24 months post-surgery to 1) baseline outcomes and 2) individuals with cervical spinal cord injury who did not undergo nerve transfer.\n\nParticipants who have received nerve transfer surgery as part of their regular medical care will complete functional hand tests, electrodiagnostic assessments, and questionnaires on independence and mood every 3 months for 24 months after surgery.",[114,115,116,117,118,30,119,32],"Spinal Cord Injury","Spinal Cord Injury at C5-C7 Level","SCI - Spinal Cord Injury","Upper Extremity Paralysis","Upper Extremity Dysfunction","Upper Extremity Paresis",[121,122,123,124,125,91,126],"spinal cord injury","upper extremity nerve transfer","nerve transfer","SCI","nerve reconstruction","paresis","2026-05-27",{"date":65,"type":37},{"date":130,"type":37},"2021-06-03",{"date":132,"type":22},"2028-01",{"name":134,"class":44},"University of British Columbia",4,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":144,"maxAge":107,"enrollmentInfo":145,"targetDuration":4,"studyType":23,"phases":147,"briefSummary":148,"conditions":149,"keywords":152,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":73},"100201147","cortical-recording-and-stimulating-array-brain-machine-interface-100201147","NCT01894802","Cortical Recording and Stimulating Array Brain-Machine Interface","A Sensorimotor Microelectrode Brain-Machine Interface for Individuals With Significant Upper Limb Impairment","CRS-BMI","Inclusion Criteria:\n\n1. Subjects must have limited or no ability to use one or both hands due to cervical spinal cord injury, brainstem stroke, brachial plexus injury, above-elbow amputation, or spinal stroke. Individuals with intact limbs must have less than grade 2 strength in finger flexor and abduction on the contralateral side to the implant and a t-score \\\u003C35 on the PROMIS Upper Extremity Short Form. The non-functional hand(s) may be involved passively in functional tasks; for example, pushing an object or passively grasping an object placed into the hand. However, the participant must report that they have no functional use of their hand(s).\n2. Subjects must report that they are unable to perform functional activities with the hand contralateral to implantation.\n3. Subjects must be over 1 year post-injury at time of implantation. In addition, subject must report no worsening in neurologic status (strength, sensation) for the previous 6 months.\n4. Subjects must be between the ages of 22-70 years old at the time of enrollment and completion of the study. Participants outside this age range may be at an increased surgical risk and increased risk of fatigue during BMI training.\n5. Subjects must live within 2 hours of the research site during the study or be willing to travel to the research site at least once per week for BMI training.\n6. If subjects do not live in the area, they are expected to stay somewhere within 2 hours of the research site for at least 18 months after enrollment.\n7. Subjects must be able to communicate with the investigators in English because of the need to follow the instructions of the study team.\n8. Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators\n9. Subjects must have results that are within normal limits on neuropsychological and psychosocial assessment; psychosocial health and support will be assessed by interview with the psychologist.\n10. Subjects must be able to activate distinct cortical areas during imagined or attempted movement tasks (i.e. hand movement and speaking or moving the mouth); this will be evaluated with functional magnetic resonance imaging (fMRI) as part of screening.\n11. Subjects must have a stable psychosocial support and caregivers who are able to perform the necessary daily care of the participant's skin and pedestal site. This requires that the subject identify a caregiver and a backup who have been in place for greater than 6 months and are able to provide needed physical and psychosocial support. This will be assessed by the sponsor-investigator and study neurosurgeon.\n12. Subjects must have a life expectancy greater than 18 months as assessed by the study investigator and neurosurgeon sub-investigator\n13. Documentation of informed consent must be obtained from the participant or their legal representative.\n14. Participants with transhumeral amputation must have been evaluated for a prosthesis, and if deemed appropriate, were fit with an optimized prosthesis. The prosthesis should be used\u002Fconsidered for the PROMIS evaluation.\n\nExclusion Criteria:\n\n1. Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses\n2. Another serious disease(s) or disorder(s) that could affect ability to participate in this study (verified during pre-op anesthesia evaluation to determine surgical risk status)\n3. Recent history of pressure sores that could be exacerbated by 1-2 days of bed rest\n4. Metallic implant(s) that would prohibit the subject from having an fMRI scan; spinal fixators are generally non-ferrous and would not exclude someone from participating in the study\n5. Any type of implantable generator such as a pacemaker, spinal cord stimulator, cochlear implant, deep brain stimulator (DBS), DBS leads, vagus nerve stimulator, or defibrillator\n6. Women of childbearing age who are pregnant, lactating, or plan to become pregnant during the next 25 months\n7. Allergy to contrast medium or kidney failure that could be exacerbated by contrast agent (for MRI)\n8. Subjects receiving medications (such as sedatives) chronically that may retard motor coordination and cognitive ability\n9. Individuals who require routine MRI, therapeutic ultrasound, or diathermy\n10. Individuals with osteomyelitis\n11. Severe skin disorder that causes excessive skin sloughing, lesions or breakdown of the scalp\n12. History of myocardial infarction or cardiac arrest or with intractable cardiac arrhythmias\n13. Individuals with an implanted hydrocephalus shunt\n14. Individuals who have had a stroke caused by a surgical procedure\n15. Active infection(s) or unexplained fever (verified during pre-op anesthesia evaluation to determine surgical risk status)\n16. Consumption of more than 1 alcoholic beverage per day on average\n17. Receiving chronic oral or intravenous steroids or immunosuppressive therapy\n18. Active cancer within the past year (other than adequately treated basal cell or squamous cell skin cancer) or require chemotherapy\n19. Uncontrolled insulin dependent diabetes mellitus\n20. Uncontrolled autonomic dysreflexia within the past 3 months (for those with spinal cord injury)\n21. Individuals with seizure disorders currently being treated with anti-epileptic medications and individuals with a familial history of seizure disorders\n22. Individuals who have attempted suicide in the past 12 months\n23. Individuals who are immunosuppressed or who have conditions that typically result in immunocompromise (including, but not limited to: ataxia-telangiectasia, cancer, Chediak-Higashi syndrome, combined immunodeficiency disease, complement deficiencies, DiGeorge syndrome, HIV\u002FAIDS, hypogammaglobulinemia, Job syndrome, leukocyte adhesion defects, malnutrition, panhypogammaglobulinemia, Bruton disease, congenital agammaglobulinemia, selective deficiency of IgA and Wiscott-Aldrich syndrome)\n24. Individuals who have had previous neurosurgical intervention involving the frontal lobes (especially the motor cortex) and\u002For parietal lobe (especially the somatosensory cortex) that is likely to impact the viability of an intracortical electrode\n25. Individuals with active psychiatric concerns, including but not limited to major depression, bipolar disorder, schizophrenia or other psychotic disorder and post-traumatic stress disorder\n26. Individuals with substance abuse within 6 months of study participation\n27. Individuals who are judged by a clinician as being an unsafe ambulator - This would be decided based on a history of frequent uncontrolled falls more than 3 or 4 in a year, or falls that resulted in injury\n28. Individuals who plan to participate in contact sports or sports that require a helmet","22 Years",{"count":146,"type":22},30,[25],"The purpose of this research study is to demonstrate the safety and efficacy of using two CRS Arrays (microelectrodes) for long-term recording of brain motor cortex activity and microstimulation of brain sensory cortex.",[30,114,28,150,151],"Brachial Plexus Injury","Above Elbow Amputation",[30,153,154,155,156,157,158,159,160,161,162,163],"Quadriplegia","Spinal cord injury","Brainstem or spinal stroke","Neuroprosthetic","Brain-machine interface","Brain-computer interface","Neural activity","Sensory stimulation","Microstimulation","Brachial plexus injury","Above elbow amputation","2026-05-18",{"date":166,"type":37},"2026-05-20",{"date":168,"type":37},"2013-12-01",{"date":170,"type":22},"2029-12",{"name":172,"class":44},"Michael Boninger",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":181,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":184,"conditions":185,"keywords":186,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":45},"100490428","brain-controlled-spinal-cord-stimulation-in-participants-with-cervical-spinal-cord-injury-for-upper-limb-rehabilitation-100490428","NCT05665998","Brain Controlled Spinal Cord Stimulation in Participants With Cervical Spinal Cord Injury for Upper Limb Rehabilitation","Brain Controlled Spinal Cord Stimulation in Participants With Cervical Spinal Cord Injury for Upper Limb Rehabilitation (UP2)","UP2","* Must provide Informed Consent as documented by signature (Appendix Informed Consent Form),\n* Must be at least 18 years old and no older than 75 years old at the time of enrolment,\n* Must be suffering from non-progressive traumatic cervical spinal cord injury,\n* Must be graded A, B, C, or D in the American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification,\n* Must have completed primary standard of care rehabilitation,\n* Must be severely impaired in his upper limb function as determined by the investigator,\n* Must have sustained the injury at least 6 months before signing the consent form,\n* Must be able to understand and interact with the study team in French or English,\n* Must agree to comply in good faith with all conditions of the study and to attend all scheduled appointments,\n* Must use safe contraception for women of childbearing capacity,\n* Must not be pregnant nor breast feeding,\n* Must not have history of severe autonomic dysreflexia,\n* Must not have brain damage,\n* Must not have history of epilepsy,\n* Must not have spinal stenosis,\n* Must not have gastrointestinal ulcers in the last five years,\n* Must not have any psychological disorder,\n* Must not have the intention to become pregnant during the course of the study,\n* Must not be known or suspected of drug or alcohol abuse,\n* Must not have participated in another clinical study using drugs or medical devices within the 30 days preceding and during the present study,\n* Must not have previously been injected with stem cells in the spinal cord,\n* Must not be the investigator himself, his\u002Fher family members, employees or other dependent persons,\n* Must not have any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations as determined by the Investigator,\n* Must not have any hematological disorders with increased risk for surgical intervention,\n* Must not require ventilator support,\n* Must not suffer from spinal cord injury from other etiology than traumatic (ischemic, tumoral, autoimmune, etc),\n* Must not be subject to spasms that limit the ability of the subject to participate in the study training as determined by the investigator,\n* Must not display spinal stenosis or post traumatic damage at location of implantation,\n* Must not require the use of an intrathecal baclofen pump,\n* Must not be implanted with a device such as pacemakers or defibrillators,\n* Must not have any indication that would require an MRI,\n* Must not suffer from congenital nor acquired upper limb abnormalities (affection of joints or bones).","75 Years",{"count":55,"type":22},[25],"Cervical spinal cord stimulation can elicit arm and hand movements through recruitment of proprioceptive neurons in the dorsal roots. In participants with cervical spinal cord injury, the spare roots bellow the lesion can be used to reactivate motor function. Decoding of motor intentions can be achieved through implantable electrocorticography (ECoG) devices.\n\nIn this study, the investigators will use an investigational system using ECoG signal recording over the motor cortex to drive muscle specific electrical epidural spinal cord stimulation (EES). The investigators will assess the safety and preliminary efficacy of this system in 3 participants.",[32,30],[187,87,188],"Spinal cord stimulation","Brain spine interface","2026-04-20",{"date":191,"type":37},"2026-04-23",{"date":193,"type":37},"2023-05-22",{"date":195,"type":22},"2026-12-31",{"name":197,"class":44},"Ecole Polytechnique Fédérale de Lausanne",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":205,"targetDuration":4,"studyType":111,"phases":4,"briefSummary":206,"conditions":207,"keywords":208,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"100538279","nerve-transfer-to-improve-function-in-high-level-tetraplegia-100538279","NCT06288763","Nerve Transfer to Improve Function in High Level Tetraplegia","Nerve Transfer to Restore Upper Limb Function and Quality of Life in High Tetraplegia","Inclusion Criteria:\n\n* 18-80 years of age\n* High cervical SCI (motor level C1-C4)\n* Motor complete SCI AIS grade A-B\n* Plateaued spontaneous recovery for at least 6 months of non-operative therapy\n* SCI greater than 6 months and fewer than 60 months since injury\n* At least MRC 4\u002F5 donor strength\n* Mentally and physically willing and able to comply with evaluations\n\nExclusion Criteria:\n\n* Active infection at the operative site or systemic infection\n* Any return or ongoing recovery of distal motor function\n* Significant joint contractures and\u002For limitations in passive range of motion in the arm\n* Mentally or physically compromised making it impossible to complete study activities\n* Immunologically suppressed\n* Currently undergoing long-term steroid therapy\n* Active malignancy\n* Pregnancy",{"count":146,"type":22},"The goal of this observational study is to determine if nerve transfer surgeries improve upper extremity function and quality of life in patients with a high level cervical spinal cord injury.\n\nParticipants will:\n\n* undergo standard of care pre- and post-op testing and study exams\n* complete pre- and post-questionnaires\n* undergo standard of care nerve transfer surgeries\n* follow-up with surgeon at 6\u002F12\u002F18\u002F24\u002F36 and potentially at 48 months\n* attend therapy at local therapist for up to 2 years postop.",[32,30],[114,209,210,211,212,30,153,213,214],"Cervical spinal cord injury","Nerve Transfer Surgery","High Cervical Spinal Cord Injury","Cervical SCI","Nerve transfer","Spinal Accessory Nerve","2026-03-10",{"date":217,"type":37},"2026-03-11",{"date":219,"type":37},"2024-02-05",{"date":221,"type":22},"2028-12-31",{"name":223,"class":44},"Washington University School of Medicine",10,{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":232,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":23,"phases":234,"briefSummary":235,"conditions":236,"keywords":237,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":45},"100481780","myhand-sci-an-active-hand-orthosis-for-spinal-cord-injury-100481780","NCT05553457","MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury","MyHand-SCI: A Wearable Robotic Hand Orthosis for C6-C7 Spinal Cord Injury","Inclusion Criteria:\n\n* Individuals with C6-C7 spinal cord injury, at least 6-months post-injury with impaired upper limb function\n* Substantially reduced motor control and strength below the level of their SCI with regard to hand and finger function\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Fixed upper limb contractures that limit functional use of the hand and arm or ability to use the device\n* Severe spasticity (modified Ashworth \\>2) at elbow, wrist, or fingers\n* Any open wounds or unusual skin fragility\n* Persistent severe pain in their upper limb",true,{"count":109,"type":22},[25],"The purpose of this study is to develop and test the hardware and software components of the MyHand-SCI device to assist with hand function for individuals with C6-C7 spinal cord injury.",[31,30],[31,30,238,239,240,241],"Rehabilitation","Robotics","Assistive Technology","Wearable Devices","2026-02-26",{"date":244,"type":37},"2026-02-27",{"date":246,"type":37},"2022-10-04",{"date":248,"type":22},"2027-09-01",{"name":250,"class":44},"Columbia University",{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":259,"targetDuration":4,"studyType":23,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":45},"100523324","feasibility-of-the-braingate2-neural-interface-system-in-persons-with-tetraplegia-bg-speech-02-100523324","NCT06094205","Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)","Understanding and Restoring Speech Production Using an Intracortical Brain-computer Interface","BG-Speech-02","Inclusion Criteria:\n\n* Between 18 and 80 years of age\n* Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders\n* Complete or incomplete tetraplegia (quadriplegia)\n* Must live within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.\n\n(There are additional inclusion criteria)\n\nExclusion Criteria:\n\n* Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses\n* Chronic oral or intravenous steroids or immunosuppressive therapy\n* Other serious disease or disorder that could seriously affect ability to participate in the study\n\n(There are additional exclusion criteria)",{"count":73,"type":22},[25],"The goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer interfaces (iBCIs) that will enable people who have lost the ability to speak fluently to communicate via a computer just by trying to speak.",[59,60,30,31,61,62,263,64],"Locked-in Syndrome","2025-11-26",{"date":266,"type":37},"2025-12-01",{"date":268,"type":37},"2023-10-16",{"date":270,"type":22},"2027-08-31",{"name":43,"class":44},{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":17,"minAge":279,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":23,"phases":281,"briefSummary":282,"conditions":283,"keywords":286,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":45},"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","21 Years",{"count":224,"type":22},[25],"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.",[114,284,30,285],"Paralysis","Paraplegia",[287,92,288,289],"paraplegia","Spinal cord injured","FES","2025-10-23",{"date":292,"type":37},"2025-10-27",{"date":294,"type":37},"2011-11-30",{"date":296,"type":22},"2027-01-31",{"name":298,"class":299},"VA Office of Research and Development","FED",{"id":301,"slug":302,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":11,"sex":17,"minAge":144,"maxAge":307,"enrollmentInfo":308,"targetDuration":4,"studyType":23,"phases":310,"briefSummary":311,"conditions":312,"keywords":313,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":45},"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).","65 Years",{"count":309,"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.",[30,153],[30,238,314,315,316,209,317,153],"Brain Computer Interface","Intracortical Microstimulation","Upper extremity prosthetics","Bilateral","2025-09-02",{"date":320,"type":37},"2025-09-09",{"date":322,"type":37},"2017-08-01",{"date":324,"type":22},"2027-09-30",{"name":326,"class":44},"Johns Hopkins University",{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":17,"minAge":144,"maxAge":107,"enrollmentInfo":334,"targetDuration":4,"studyType":23,"phases":335,"briefSummary":336,"conditions":337,"keywords":338,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":45},"100329283","investigation-on-the-cortical-communication-corticom-system-100329283","NCT03567213","Investigation on the Cortical Communication (CortiCom) System","CortiCom","Inclusion Criteria:\n\n* Clinical diagnosis of tetraplegia (quadriplegia), brainstem stroke , amyotrophic lateral sclerosis (ALS) or Locked-in Syndrome (LIS)\n* Tetraplegia diagnosis, ALS diagnosis, stroke, or LIS etiology onset occurred at least one year prior to enrollment\n* Complete or incomplete tetraplegia (quadriplegia), tetraparesis (quadriparesis), or severe ataxia. In addition, these motor impairments may be combined with severe motor-related speech impairment (dysarthria or anarthria), as in LIS.\n* 22-70 years\n* Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants\n* Ability to communicate reliably, such as through eye movement\n* Willingness and ability to provide informed consent\n* Screened by rehabilitation psychologist with a result showing that the participant has a stable psychosocial support system with caregiver capable of monitoring participant throughout the study\n* Ability and willingness to travel up to 100 miles to study location up to three days per week for the duration of the study\n* Ability to understand and comply with study session instructions\n* Participant consents to the study and still wishes to participate at the time of the study\n\nExclusion Criteria:\n\n* Performance on formal neuropsychological testing that indicates significant psychiatric conditions or cognitive impairments that would interfere with obtaining informed consent or fully participating in study activities.\n* Suicide attempt or persistent suicidal ideation within the past 12 months.\n* Implanted devices that are incompatible with MRI, which may include pacemakers, cardiac defibrillators, spinal cord or vagal nerve stimulators, deep brain stimulators, and cochlear implants.\n* History of substance abuse, narcotic dependence, or alcohol dependence in past 24 months\n* Medical conditions contraindicating surgery of a chronically implanted device (e.g. osteomyelitis, diabetes, hepatitis, any autoimmune disease\u002Fdisorder, epilepsy, skin disorders causing excessive skin sloughing or poor wound healing, blood or cardiac disorder requiring chronic anti-coagulation)\n* Other chronic, unstable medical conditions that could interfere with subject participation.\n* Presence of pre-surgical findings in anatomical, functional, and\u002For vascular neuroimaging that makes achieving implant locations within desired risk levels too challenging (to be decided by neurological and neurosurgical team)\n* Prior cranioplasty\n* Inability to undergo MRI or anticipated need for an MRI during the study period\n* Participants with active infections or unexplained fever\n* Participants with other morbid conditions making the implantation of the recording elements unsafe; not limited to: significant pulmonary, cardiovascular, metabolic, or renal impairments making the surgical procedure unsafe\n* Pregnancy (confirmation through blood test)\n* Nursing an infant, planning to become pregnant, or not using adequate birth control\n* Corrected vision poorer than 20\u002F100\n* HIV or AIDS infection\n* Existing scalp lesions or skin breakdown\n* Chronic oral or intravenous use of steroids or immunosuppressive therapy\n* Active cancer within the past year or requires chemotherapy\n* Uncontrolled autonomic dysreflexia within the past 3 months\n* Hydrocephalus with or without an implanted ventricular shunt\n* Participants in whom it is medically contraindicated to stop anti-coagulant medications during surgery",{"count":55,"type":22},[25],"The CortiCom system consists of 510(k)-cleared components: platinum PMT subdural cortical electrode grids, a Blackrock Microsystems patient pedestal, and an external NeuroPort Neural Signal Processor. Up to two grids will be implanted in the brain, for a total channel count of up to 128 channels, for six months. In each participant, the grid(s) will be implanted over areas of cortex that encode speech and upper extremity movement.",[30,263,28,61],[30,29,263,339,314,238,340,341],"Brainstem stroke","Stroke","Hopkins","2025-07-22",{"date":344,"type":37},"2025-07-25",{"date":346,"type":37},"2021-12-14",{"date":348,"type":22},"2026-08-31",{"name":326,"class":44},{"id":351,"slug":352,"hasResults":11,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":11,"sex":17,"minAge":144,"maxAge":307,"enrollmentInfo":358,"targetDuration":4,"studyType":23,"phases":360,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":45},"100354736","an-early-feasibility-study-of-the-rehab-system-100354736","NCT03898804","An Early Feasibility Study of the ReHAB System","An Early Feasibility Study to Assess the Effects of the \"Reconnecting the Hand and Arm to the Brain (ReHAB)\" System","ReHAB","Inclusion Criteria:\n\n1. Age between 22 and 65 years of age.\n2. Tetraplegia due to a static identified disease process (spinal cord injury or stroke) that prevents functional activity of the upper extremity.\n3. Onset of tetraplegia at least 12 months prior to enrollment, with stability of weakness for at least 3 months.\n4. Must have sufficiently intact cortical motor structures and stable medical prognoses to be able to perform the BCI control tasks for at least one year. .\n5. Ability to speak understandably or, if unable to speak understandably, a reliable means of yes\u002Fno communication.\n6. Life expectancy greater than 13 months.\n7. Chronic care environment within a three-hour drive of the study site or the ability to temporarily relocate to a residence within a three-hour drive of the study site.\n8. Willingness to remain available (geographically stable) for at least 13 months after enrollment, including maintenance of the evaluation schedule, frequent visits to the Investigator's office, and visits of Sponsor personnel to the subject's chronic care environment.\n9. Willingness to allow videotape recordings to be made of the surgical procedure (for training purposes) and portions of the Feasibility Evaluations.\n10. A stable psychosocial support system.\n11. Scalp devoid of any lesions or skin breakdown precluding surgery.\n12. Ability to provide voluntarily informed consent in accordance with Site institutional policies and willingness to release of Personal Health Information from the date of the injury or disease onset through the completion of the clinical Study.\n13. Availability of caregivers capable of providing the necessary daily care of the subject's skin and electrode externalization sites.\n\nExclusion Criteria:\n\n1. Presence of an implanted stimulator such as a pacemaker, spinal cord stimulator, cochlear implant, deep brain stimulator, vagus nerve stimulator, or defibrillator. (Implanted intrathecal pumps for pain or spasticity, cough implants, or diaphragmatic pacers are not excluded.)\n2. Any active infection(s) or unexplained fever.\n3. Active cancer within the one year prior to enrollment (other than adequately treated basal or squamous cell skin cancer).\n4. Uncontrolled insulin-dependent diabetes mellitus.\n5. Hydrocephalus requiring diversion of cerebrospinal fluid.\n6. Autonomic dysreflexia within three months prior to enrollment that required urgent evaluation and pharmacologic intervention prescribed by a physician.\n7. Seizure within 3 months prior to enrollment.\n8. Any medical condition expected to require routine MRI imaging or subjects with contraindication(s) to MRI.\n9. History of osteomyelitis or skin disorder that causes excessive skin sloughing, lesions or breakdown of the scalp.\n10. Chronic use of medications such as sedatives that may significantly retard motor coordination and cognitive ability.\n11. Chronic use of anticoagulant medications. (Subjects receiving prophylactic anticoagulation solely for the prevention of deep venous thrombosis are not excluded, but must be able to have their prophylactic anticoagulation suspended temporarily for the surgical procedure and immediate post-operative period.)\n12. Chronic use of steroids or immunosuppressant therapy.\n13. Active treatment for another serious medical, neurological or psychiatric disease or disorder that could seriously affect the subject's ability to undergo surgical implantation of the electrodes or participate in the testing sessions.\n14. Pregnant, lactating, or of childbearing age and not using adequate birth control.\n15. Active consumption of more than 1 alcoholic beverage per day.\n16. Suicide attempt within 12 months prior to enrollment.\n17. History of myocardial infarction or unstable cardiac arrhythmia.\n18. Enrollment in any other investigational study that may interfere with the time commitments required of this study.\n19. Subjects who are immunocompromised.\n20. Subjects who require ongoing diathermy or ultrasound treatments.\n21. Subjects with severe upper extremity joint contractures or Ashworth spasticity scores of 4 that would limit functional movements.\n22. Subjects who have contraindication(s) to CT.\n23. Subjects who are ventilator dependent. Subjects who are sometimes ventilator-assisted (for example, while sleeping) are not excluded.",{"count":359,"type":22},12,[25],"The purpose of this research study is to examine the feasibility of a system that involves implanting small electrodes in the parts of the brain that control movement and sensation, and combining that with electrodes in the upper arm and shoulder to activate paralyzed muscles of the arm and hand. This system is intended for people with extensive paralysis in their arms. The small electrodes in the brain will be used to attempt to measure intended movements, and the muscles in the arm and hand will be stimulated to attempt to follow those intentions.\n\nThe study is a prospective, non-randomized, open-label, exploratory safety\u002Ffeasibility trial of up to 12 subjects. The Primary Endpoint will be evaluation over the first 13 months after implantation, after which the subjects will have the option of removal of the device or continued participation in a long-term study.",[30],"2025-07-11",{"date":365,"type":37},"2025-07-16",{"date":367,"type":37},"2019-04-09",{"date":369,"type":22},"2027-03-01",{"name":371,"class":44},"Jennifer Sweet, MD",{"id":373,"slug":374,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":380,"targetDuration":4,"studyType":23,"phases":381,"briefSummary":382,"conditions":383,"keywords":384,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":45},"100597439","control-interfaces-for-operating-assistive-devices-100597439","NCT07058506","Control Interfaces for Operating Assistive Devices","Evaluation of Non-invasive Control Interfaces for Operating Assistive Devices for Tetraplegic Individuals","SENSORS","Inclusion Criteria:\n\n* Spinal cord injury defined by an AIS A, B or C score (AIS A, B or C): complete or incomplete motor deficit below the lesion. This is a standard for describing spinal cord injuries that has been internationally agreed upon.\n* Spinal cord injury at the neurological level \\> C7\n* Age greater than or equal to 18 and less than or equal to 80 years\n* A history of more than 3 months of neurological stability, with no changes in muscle testing.\n* Participants capable of following instructions for testing and providing feedback on the use of the device.\n* Participants who have signed the informed consent form to participate in the study after being fully informed.\n* Participants affiliated with a social security system (either as a beneficiary or a dependent), excluding those covered by State Medical Aid (AME).\n\nExclusion Criteria:\n\n* Participant deprived of liberty (by judicial or administrative decision).\n* Adult participants are under legal protection or unable to provide informed consent.\n* Participation in another ongoing clinical trial.\n* Unstable psychiatric condition.\n* Severe cognitive impairment.\n* Unstable acute medical condition\n* Insufficient proficiency in spoken and written French.",{"count":146,"type":22},[25],"Neurinnov, in collaboration with the CBV USSAP center and the CAMIN INRIA team, has conducted clinical investigations using various control interfaces, including EMG, IMU, contact sensors, and voice commands, to operate a motor neuroprosthesis. This neuroprosthesis is based on neural electrical stimulation, enabling the activation of multiples muscles via a single electrode. The clinical investigations have successfully demonstrated the feasibility of achieving grasping movements induced by neural electrical stimulation, which are controlled by the participant through external interfaces.\n\nThese external interfaces were based on existing technologies but were only suitable for research purposes due to their lack of portability. The current investigation aims to validate fully portable interfaces designed by Neurinnov, which are intended to be integral components of a future medical device that includes an implanted stimulator and its neural electrodes. The study's goal is to demonstrate that these interfaces can be used by participants with sufficient success rate (clinical performance) to support daily use.\n\nOur main hypothesis is that the participants can effectively use at least two of the six control interfaces presented to them to detect their intention to perform a motor action within a software environment under constant conditions. These interfaces include voice commands, inertial measurement unit (IMU) sensors, surface electromyography (EMG) sensors, switch, joystick, and earswitch.",[30],[30,385,386],"Non-invasive control interfaces","Sensors","2025-06-30",{"date":389,"type":37},"2025-07-10",{"date":391,"type":37},"2024-11-18",{"date":393,"type":22},"2025-12-31",{"name":395,"class":44},"Centre Bouffard Vercelli - USSAP",{"id":397,"slug":398,"hasResults":11,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":402,"eligibilityCriteria":403,"healthyVolunteers":11,"sex":17,"minAge":279,"maxAge":181,"enrollmentInfo":404,"targetDuration":4,"studyType":23,"phases":405,"briefSummary":406,"conditions":407,"keywords":408,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":73},"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":224,"type":22},[25],"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.",[31,340,284,30,285],[409,410,411,340,285,30],"Neurologic disorders","Rare disease","Spinal cord injuries","2025-06-12",{"date":414,"type":37},"2025-06-15",{"date":416,"type":37},"2018-06-01",{"date":418,"type":22},"2027-12-31",{"name":420,"class":44},"Case Western Reserve University",{"id":422,"slug":423,"hasResults":11,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":307,"enrollmentInfo":429,"targetDuration":4,"studyType":23,"phases":431,"briefSummary":432,"conditions":433,"keywords":435,"overallStatus":437,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":444,"locationsCount":73},"100592206","a-clinical-trial-to-evaluate-the-safety-and-efficacy-of-an-implantable-wireless-brain-computer-interfacebcisystem-neo-in-patients-with-tetraplegia-100592206","NCT06990412","A Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Wireless Brain-Computer Interface（BCI）System NEO in Patients With Tetraplegia","A Prospective, Multi-Center Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Wireless Brain-Computer Interface（BCI）System NEO in Patients With Tetraplegia","NEO","Inclusion Criteria:\n\n1. Age between 18 and 65 years old, no restriction on gender.\n2. Tetraplegia caused by cervical spinal cord injury.\n3. Score of ≤1 on either the ball grasp or water pouring tasks of the ARAT (Action Research Arm Test).\n4. Muscle strength of finger flexors \\\u003C grade 3 according to ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury).\n5. Score of ≥2 for \"hand to mouth\" on ARAT; scores of ≥1 for both \"hand to top of head\" and \"hand to behind the head.\"\n6. Neurological assessment indicates normal function of the motor-related cortex, with no significant structural lesions or functional disorders identified.\n7. Diagnosis confirmed for at least 12 months, with a stable condition for at least 6 months following standard treatment.\n8. Normal cognitive function, good compliance, and voluntarily agrees to participate in the clinical trial.\n\nExclusion Criteria:\n\n1. Without the consent of the patient or the patient's legal guardian.\n2. Presence of syringomyelia, severe neuropathic pain, or severe spasticity that limits the participant's ability to engage in training.\n3. Requires ventilator support.\n4. Baclofen dosage \\>30 mg\u002Fday.\n5. Received botulinum toxin injections in the upper limb, neck, or hand within 6 months prior to enrollment, or received stem cell therapy within 1 year.\n6. High risk of surgical complications, such as active systemic infection, coagulation disorders (e.g., receiving anticoagulant therapy), or platelet count below 50,000.\n7. Patients who have already been implanted with medical devices that deliver electrical energy to the central nervous system.\n8. Any unstable or significant medical condition that may interfere with study procedures or confound the evaluation of study endpoints, such as depression, mood disorders, or other cognitive impairments.\n9. Diagnosed with severe, unstable, and uncontrolled complex regional pain syndrome.\n10. Autoimmune-mediated spinal cord dysfunction\u002Finjury.\n11. History of other neurological disorders, such as stroke, multiple sclerosis, traumatic brain injury, or drug-resistant epilepsy.\n12. Peripheral neuropathies (e.g. diabetic polyneuropathy, compressive neuropathies).\n13. In the investigator's opinion, the study is unsafe or inappropriate for the participant, or the participant is unlikely to comply with the study follow-up schedule.",{"count":430,"type":22},32,[25],"To evaluate the safety and efficacy of a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO in patients with tetraplegia and to provide a basis for product registration.\n\nThrough brain-computer interface alternative technology, patients can control the external equipment with brain signals to improve the patient's quality of life.",[30,434],"Spinal Cord Injuries (SCI)",[436,154],"BCI, NEO, Tetraplegia","NOT_YET_RECRUITING","2025-05-23",{"date":440,"type":37},"2025-05-25",{"date":442,"type":22},"2025-05-20",{"date":166,"type":22},{"name":445,"class":446},"Neuracle Medical Technology(Shanghai) Co.,Ltd.","INDUSTRY",{"id":448,"slug":449,"hasResults":11,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":181,"enrollmentInfo":454,"targetDuration":4,"studyType":23,"phases":455,"briefSummary":456,"conditions":457,"keywords":458,"overallStatus":437,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":470,"locationsCount":45},"100526896","feasibility-of-home-based-transcutaneous-spinal-cord-stimulation-for-persons-with-sci-100526896","NCT06140706","Feasibility of Home Based Transcutaneous Spinal Cord Stimulation for Persons With SCI","Feasibility of a Video Telehealth Model to Evaluate Home Use of Transcutaneous Spinal Cord Stimulation for Enhanced Upper Limb Function","Inclusion Criteria:\n\n1. Veteran\n2. Age 18-65\n3. All gender, any ethnicity\n4. Cervical Spinal Cord Injury C2-8\n5. American Spinal Injury Association (ASIA) Impairment Scale (AIS) B, C or D\n6. GRASSP-Prehension Score \\>10 or GRASSP Strength Score \\>30\n7. Greater than 1 year post injury\n8. Able to identify a companion to assist with neurostimulator setup in home environment.\n9. Internet connection to support video telehealth connection\n10. Willingness to travel to the VA Palo Alto Medical Center\n\nExclusion Criteria:\n\n1. Cardiopulmonary disease or cardiac symptoms,\n2. Autonomic dysreflexia that is uncontrolled or severe,\n3. Implanted medical device(s),\n4. Uncontrolled spasms that could limit participation in exercise training,\n5. Skin breakdown or active pressure injury in areas of electrode placement.\n6. Participants must not be engaged in any concurrent drug or device trial\n7. Pregnant, are planning to become pregnant, or breastfeeding\n8. The study is not deemed safe or appropriate in the opinion of the investigators",{"count":224,"type":22},[25],"The proposed study will focus on the feasibility of and effectiveness to a home-based program for persons with chronic SCI focused on upper limb training augmented with a transcutaneous neurostimulator supported via a video telehealth platform.",[30],[459,460,461,462,463],"paralysis","exercise","telemedicine","spinal cord stimulation","physical activity","2025-04-07",{"date":466,"type":37},"2025-04-10",{"date":468,"type":22},"2025-09-01",{"date":418,"type":22},{"name":471,"class":299},"VA Palo Alto Health Care System",{"id":473,"slug":474,"hasResults":11,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":307,"enrollmentInfo":479,"targetDuration":4,"studyType":111,"phases":4,"briefSummary":480,"conditions":481,"keywords":485,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":45},"100557663","nerve-transfers-plus-electrical-stimulation-to-improve-hand-function-in-cervical-spinal-cord-injury-100557663","NCT06541041","Nerve Transfers Plus Electrical Stimulation to Improve Hand Function in Cervical Spinal Cord Injury","Evaluation of Electrical Stimulation During Nerve Transfer Surgery for Cervical Spinal Cord Injury","Inclusion Criteria:\n\n1. Cervical spinal cord injury, ASIA A or ASIA B\n2. International Standards for Neurological Classification of Spinal Cord Injury neurological level of injury C6 or C7\n3. Agreed upon surgical plan includes at least 1 nerve transfer targeting finger flexion with the anterior interosseous nerve as the recipient and at least 1 nerve transfer targeting finger extension with the posterior interosseous nerve as the recipient\n4. Age 18-65 years\n5. Mentally and physically able to comply with evaluations and assessments\n6. Upper motor neuron pattern of injury in the recipient nerve with planned surgery 36 months or less from the time of injury OR lower motor neuron pattern of injury in the recipient nerve with planned surgery 9 months or less from the time of injury\n7. Muscle grade at least 4+\u002F5 on the Medical Research Council (MRC) scale in the territory of the donor nerve(s)\n8. Stable function for at least 3 months (i.e., no ongoing recovery)\n9. Non-operative rehabilitation for at least 3 months\n10. Able to read and write in English at a level necessary to complete the questionnaires\n\nExclusion Criteria:\n\n1. Contraindication to electrical stimulation, including any implanted electronic device such as a pacemaker or intrathecal drug delivery pump\n2. Active infection at the operative site or systemic infection\n3. Active malignancy\n4. Pregnancy\n5. Joint contractures or limited passive range of motion that would limit recovery of function\n6. Lack of appropriate social support and\u002For infrastructure to commit to scheduled follow-up visits\n7. Previous tendon transfer or other surgery for restoration of function following cervical spinal cord injury\n8. Planned tendon transfer surgery or other surgery for restoration of function following cervical spinal cord injury",{"count":224,"type":22},"The goal of this prospective observational study is to determine whether brief intraoperative electrical stimulation and temporary postoperative electrical stimulation improve motor and\u002For pain outcomes for patients with cervical spinal cord injury undergoing standard of care nerve transfer surgery to improve hand function.\n\nThe main hypotheses include:\n\nHypothesis #1: Brief intraoperative electrical stimulation of the donor nerves will result in improved motor outcomes (hand function) compared to standard nerve transfer surgery in patients with cervical spinal cord injuries.\n\nHypothesis #2: Placement of a temporary peripheral nerve stimulator for 60 days of postoperative electrical stimulation will result in improved pain outcomes compared to standard nerve transfer surgery in patients with cervical spinal cord injuries.\n\nResearchers will prospectively enroll patients with cervical spinal cord injury and no hand function who will undergo standard of care nerve transfer surgery combined with standard of care brief intraoperative electrical stimulation and temporary postoperative electrical stimulation. Motor and pain outcomes will be compared to a retrospective group of patients who underwent nerve transfer surgery without intraoperative or postoperative electrical stimulation.\n\nParticipants will receive standard medical care (nothing experimental) as part of this study. Participants will:\n\n* Have a preoperative assessment including physical examination, electrodiagnostic studies, functional electrical stimulation, and will complete questionnaires assessing function and quality of life\n* Agree upon a surgical plan, including the specific nerve transfers to be performed and whether to include brief intraoperative electrical stimulation and\u002For temporary postoperative electrical stimulation before being considered for enrollment in the study\n* Will undergo standard of care nerve transfer surgery, with at least one nerve transfer targeting improvement in hand function and will receive brief intraoperative electrical stimulation of the donor nerves and placement of a temporary peripheral nerve stimulator\n* Will follow-up with the surgeon 3, 6, 12, 24, and 36 months after the surgery\n* Will have a physical examination and will complete questionnaires at the postoperative visits\n* Will participate in hand therapy following the operation\n* Will be eligible for placement of a permanent peripheral nerve stimulator, depending on response to the temporary peripheral nerve stimulator.",[32,482,30,483,484],"Cervical Spinal Cord Paralysis","Tetraplegia\u002FTetraparesis","Tetraplegic Spinal Paralysis",[32,486,487,488,30],"Nerve Transfer","Brief Intraoperative Electrical Stimulation","Peripheral Nerve Stimulation","2025-02-16",{"date":491,"type":37},"2025-02-19",{"date":493,"type":37},"2025-02-10",{"date":495,"type":22},"2028-09",{"name":497,"class":44},"Stanford University",{"id":499,"slug":500,"hasResults":11,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":505,"targetDuration":4,"studyType":23,"phases":507,"briefSummary":508,"conditions":509,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":135},"100509956","clinical-trial-to-evaluate-the-safety-and-efficacy-of-an-implantable-neural-acquisitor--stimulator-system-in-patients-with-motor-disability-100509956","NCT05920174","Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability","A Prospective Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability","Inclusion Criteria:\n\n1. Aged between 18 and 80 years of age;\n2. Complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders;\n3. After the neurological assessment, the brain motor-related cortex is functional, and there is no obvious organic disease or functional disease；\n4. The above diseases have been diagnosed for at least 12 months and stable for at least 6 months after standard treatment；\n5. The patient had normal cognitive function, good compliance and volunteered to participate in the clinical trial.\n\nExclusion Criteria:\n\n1. Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses；\n2. Combined with progressive neurological disease；\n3. Combined with surgical contraindications identified by surgeons and anesthesiologists;\n4. Participating in other clinical trials;\n5. Other conditions deemed inappropriate by investigators and medical staff.",{"count":506,"type":22},9,[25],"Through brain-computer interface alternative technology, patients can control the external equipment（wheelchairs, robotic arms, the WeChat app and other physical aids）with brain signals to improve the patients quality of life.",[30],"2024-12-03",{"date":512,"type":37},"2024-12-05",{"date":514,"type":37},"2023-10-17",{"date":516,"type":22},"2025-12",{"name":445,"class":446},{"id":519,"slug":520,"hasResults":11,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":307,"enrollmentInfo":525,"targetDuration":4,"studyType":23,"phases":526,"briefSummary":527,"conditions":528,"keywords":530,"overallStatus":437,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":4},"100549708","epidural-stimulation-for-upper-extremity-function-100549708","NCT06437548","Epidural Stimulation for Upper Extremity Function","Spinal Cord Stimulation for Reanimation After Nervous System Injury","Inclusion Criteria:\n\n* Age ≥18 years and ≤65\n* Provides informed consent\n* History of upper extremity nerve transfer \\> 6 months prior to enrollment\n* Completion of standard post-nerve transfer occupational therapy\n* Baseline upper extremity strength of \\\u003C 5\u002F5 grade with the MRC\n* Scheduled to undergo a cervical spinal cord stimulation procedure for chronic pain refractory to first line therapy\n* Willing and able to adhere to the study protocol\n\nExclusion Criteria:\n\n* Central nervous system (CNS) malignancy\n* A contraindication to the SCS procedure\n* Diagnosis that precludes the patient from full participation in the protocol\n* A functional implanted device (pacemaker, vagus nerve device, baclofen pump)\n* Botulinum toxin injection in upper extremity muscles \\\u003C 6 months prior to enrollment\n* For female participants, current\u002Fplanned pregnancy (females of childbearing age will be asked to take a pregnancy test on the day of the intervention)\n* Other factors that prevent participation in the opinion of the surgeon-principal investigator",{"count":5,"type":22},[25],"Restoring upper extremity function in patients with cervical spinal cord injury is extremely important for patients' independence and quality of life.\n\nAt present, there are limited options for hand or arm reanimation in this patient population. Nerve transfer is one such option that can partially restore the natural movement of hand or arm function in select patients.\n\nThe investigators are interested in understanding whether recovery of hand or arm motor function after nerve transfer can be augmented by cervical epidural spinal cord stimulation.",[529,30],"Spinal Cord Injury Cervical",[531,532,533,534,535,536,537],"spinal","cord","stimulation","percutaneous","peripheral","nerve","transfer","2024-05-30",{"date":540,"type":37},"2024-05-31",{"date":542,"type":22},"2024-09",{"date":544,"type":22},"2027-09",{"name":546,"class":44},"Brigham and Women's Hospital"]