[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spinal-cord-injury-chronic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spinal-cord-injury-chronic":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,85,114],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100587114","utsw-norc-pilot-spinal-cord-injury-dietary-program-100587114",false,"NCT06924177","UTSW NORC Pilot Spinal Cord Injury Dietary Program","Utilizing Dietician-guided Intervention to Combat Neurogenic Obesity in People With Spinal Cord Injury","Inclusion Criteria:\n\n* age 18-65 years old\n* have had SCI for more than one year\n* not independently ambulatory\n* primarily uses a wheelchair for mobility\n* community-dwelling\n* without comorbidities listed in the exclusion criteria\n\nExclusion Criteria:\n\n* uncontrolled type 2 diabetes mellitus\n* pregnancy\n* active systemic disease, e.g., heart disease, real failure\u002Finsufficiency, multiple myeloma, lupus with nephropathy, sickle cell disease, symptomatic myasthenia gravis, poorly controlled hypo- or hyperthyroidism.","ALL","18 Years","65 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this observational study is to learn about the effects of a 9-week dietician-guided program modified from the National Diabetic Prevention Program (modified DPP-diet) in people with spinal cord injury on body composition and insulin sensitivity.\n\nThe main question it aims to answer is:\n\nDoes 9 week modified DPP-diet reduce body fat percentage and insulin resistance?\n\nParticipants will:\n\nHave 9 weeks of Telehealth visit with dietician certified in providing DPP. Visit the laboratory before, immediately and 9 weeks after completion of the modified DPP-diet.\n\nShare with the researcher on the perceived benefit and obstacles in implementing the modified DPP-diet as part of their daily activities.",[27,28],"Obesity and Obesity-related Medical Conditions","Spinal Cord Injury, Chronic",[30,31,32],"spinal cord injuries","obesity","insulin resistance","RECRUITING","2026-03-26",{"date":36,"type":37},"2026-03-31","ACTUAL",{"date":39,"type":37},"2026-02-13",{"date":41,"type":21},"2026-05-31",{"name":43,"class":44},"University of Texas Southwestern Medical Center","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100580781","phase-1-a-study-to-evaluate-the-safety-of-a-delivery-device-for-administering-lctopc1-in-participants-with-spinal-cord-injury-100580781","NCT06841770","A Study to Evaluate the Safety of a Delivery Device for Administering LCTOPC1 in Participants With Spinal Cord Injury","Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device (DOSED)","DOSED","Inclusion Criteria:\n\n1. Sensorimotor complete, traumatic SCI (ASIA Impairment Scale A) or sensory incomplete, traumatic SCI (ASIA Impairment Scale B)\n2. For subjects with subacute injury, International Standards for Neurological Classification of SCI (ISNCSCI) Neurological Level of Injury (NLI) from C-4 to T-10 occurring 21 to 42 days prior to LCTOPC1 injection\n3. For subjects with chronic injury, ISNCSCI NLI from C-4 to T-10 and more than 30 days without clinical improvement from last assessment, occurring 1 to 5 years prior to LCTOPC1 injection\n4. Individuals must have at least one upper extremity ISNCSCI key muscle with at least 1\u002F5 strength\n5. 18 through 65 years of age, inclusive, at time of consent\n6. Single injury with sufficient visualization of the spinal cord injury epicenter and lesion margins to enable post-injection safety monitoring\n7. Informed consent for this protocol must be provided and documented (i.e., signed ICF)\n8. Able to participate in an elective surgical procedure to inject LCTOPC1 21 days or later following SCI\n9. Female subjects of child-bearing potential must agree to the use of contraception for 1 year following LCTOPC1 injection; male subjects must agree to use contraception to prevent pregnancy in any female partners of child-bearing potential for 1 year following LCTOPC1 injection\n\nExclusion Criteria:\n\n1. SCI due to penetrating trauma\n2. Traumatic anatomical transection, laceration, or inadequate decompression of the spinal cord based on prior surgery or MRI\n3. Any concomitant injury that interferes with the performance, interpretation, or validity of neurological examinations, such as multiple spinal cord lesions, brachial\u002Flumbar plexus injury, cauda equina injury or traumatic brain injury\n4. Subjects with a cavity structure that would preclude successful transplantation, as identified on MRI, which may include septations or irregularities in tissue structure\n5. Persons with syringomyelia, defined as those with progressively enlarging cysts on T2-weighted images associated with neurological decline\n6. Inability to communicate effectively with neurological examiner such that the validity of patient data could be compromised\n7. Organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression\n8. Need for mechanical support of ventilation (ventilator, continuous positive airway pressure \\[CPAP\\], bi-level positive airway pressure \\[BiPAP\\]), excluding supplemental oxygen, at baseline\n9. History of any malignancy (except non-melanoma skin cancers). For cancers in remission for more than five years, enrollment is allowed with concurred documented approval of principal investigator, oncologist, and Sponsor's medical monitor prior to enrollment\n10. Pregnant or nursing women\n11. Subjects with an implanted spinal cord stimulator (SCS), whether temporary or permanent.",{"count":55,"type":21},10,[57],"PHASE1","The DOSED clinical study evaluates the safety and utility of a novel delivery device to deliver LCTOPC1, a cell therapy, to the spinal cord of patients with a spinal cord injury (SCI). LCTOPC1 is designed to replace or support cells that are absent or dysfunctional due to traumatic injury, with a goal to help improve the quality of life and restore or augment functional activity in persons suffering from a traumatic cervical or thoracic injuries.",[60,61,62,63,28],"Spinal Cord Injury Cervical","Spinal Cord Injury Thoracic","Spinal Cord Injury, Acute","Spinal Cord Injury",[63,52,65,66,67,68,69,70,71,72,73],"Subacute spinal cord injury","Oligodendrocyte Progenitor Cell","Chronic spinal cord injury","Stem Cell Transplant","Cervical spinal cord injury","Thoracic spinal cord injury","Paralysis","Quadriplegia","Tetraplegia","2026-02-11",{"date":76,"type":37},"2026-02-12",{"date":78,"type":37},"2025-06-30",{"date":80,"type":21},"2037-06-30",{"name":82,"class":83},"Lineage Cell Therapeutics, Inc.","INDUSTRY",2,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":45},"100603366","non-invasive-interventions-for-respiratory-recovery-in-chronic-spinal-cord-injury-100603366","NCT07135583","Non-Invasive Interventions for Respiratory Recovery in Chronic Spinal Cord Injury","Non-Invasive Interventions and Biomarker Identification for Respiratory Recovery in Chronic Spinal Cord Injury","Combinatorial","Inclusion Criteria:\n\n1. adults 18 to 70 years of age (the latter to reduce likelihood of cardiovascular disease);\n2. chronic SCI for ≥ 1 year at or below C-3 to T-8\n3. incomplete SCI based on classification of incomplete-B, C or D\n4. medically stable with clearance from physician\n5. SCI due to non-progressive etiology\n6. \\>20% impairment in maximal inspiratory or expiratory pressure generation\n\nExclusion Criteria:\n\n* Individuals will be excluded due to (1) current diagnosis of an additional neurologic condition (eg. multiple sclerosis or stroke) (2) loss of diaphragm EMG activity on forced respiratory tests; (3) severe illness or infection (4) non-healing decubitus ulcers (5) untreated bladder or urinary infections (6) cardiovascular disease (7) lung disease (8) active heterotopic ossification (9) uncontrolled hypertension; (10) severe neuropathic pain; (11) pregnancy (5) severe recurrent and uncontrolled autonomic dysreflexia (6) history of seizure disorder.","70 Years",{"count":20,"type":21},[24],"Spinal cord injuries (SCI) can seriously affect a person's ability to breathe. This happens because the injury can damage the nerves that control the muscles used for breathing. As a result, people with SCI often face breathing problems, a higher risk of lung infections, and even early death. While breathing exercises can help strengthen these muscles, they often aren't intense enough to make a big difference, especially in people with long-term injuries.\n\nThis research project is exploring a new way to improve breathing in people with chronic SCI. The goal is to \"wake up\" the remaining nerve pathways that still connect the brain and spinal cord to the breathing muscles. By doing this, the investigators hope to make breathing exercises more effective and improve overall respiratory health.\n\nThe investigators are testing a combination of two non-invasive (non-surgical) techniques:\n\nTranscutaneous Spinal Cord Stimulation (tSCS): This uses small electrical pulses delivered through the skin to stimulate the spinal cord and help activate the muscles used for breathing.\n\nHypercapnic-Hypoxia Protocol (HiCO₂-AIH): This involves breathing air with lower oxygen and higher carbon dioxide for short periods. This naturally increases the brain's drive to breathe and may help strengthen the breathing muscles.\n\nThe investigators believe that using these two techniques together will \"prime\" the nervous system, making it more responsive to breathing exercises. This could lead to better outcomes for people with SCI.\n\nIn addition to testing this treatment, the investigators are also collecting saliva and blood samples to look for biomarkers-biological clues that might help predict who will benefit most from this therapy. These include genetic markers and signs of nerve damage in the blood.\n\nWho Can Participate\n\nThe investigators are looking for adults aged 18 to 70 who:\n\nHave had a spinal cord injury for at least one year. Have an injury between the neck and upper back (from C3 to T8). Have an incomplete injury (some nerve function remains). Are medically stable and cleared by a doctor. Have at least a 20% reduction in breathing strength. What Participants Will Do\n\nEach participant will complete four rounds of treatment. Each round includes four days in a row of therapy, followed by a three-week break before the next round.\n\nEach daily session lasts about two hours and includes:\n\nBreathing special air mixtures (low oxygen and high carbon dioxide) for short periods, followed by normal air.\n\nA short break. Then, spinal cord stimulation combined with breathing exercises that use resistance (like breathing through a straw).\n\nWhat the Investigators Will Measure\n\nThe investigators will track:\n\nBreathing ability using lung function tests and pressure measurements. Nerve activity using brain and spinal cord stimulation to see how well the diaphragm (the main breathing muscle) responds.\n\nSafety by monitoring oxygen levels, heart rate, blood pressure, and breathing responses during each session.\n\nBiological Samples\n\nParticipants will provide:\n\nA one-time saliva sample for genetic testing. A one-time blood sample to look for markers of nerve injury. Why This Matters\n\nThis study could lead to new, non-invasive treatments that improve breathing and quality of life for people living with spinal cord injuries. By identifying who is most likely to benefit from this therapy, the investigators can also move toward more personalized and effective care in the future.",[28,60,61,98],"Incomplete Spinal Cord Injury",[100,101,102,103,104],""Spinal Cord Stimulation" [MeSH]","acute intermittant hypoxia","respiratory resistance training","Genetic Biomarker","Blood biomarker","2026-02-02",{"date":107,"type":37},"2026-02-05",{"date":109,"type":37},"2025-09-18",{"date":111,"type":21},"2027-08-15",{"name":113,"class":44},"Thomas Jefferson University",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":122,"maxAge":18,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":134,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":45},"100588304","bci-assisted-scs-exs-for-gait-optimization-100588304","NCT06939660","BCI-Assisted SCS-EXS for Gait Optimization","Spatiotemporal Spinal Cord Stimulation Based on Implantable Brain-machine Interfaces and Exoskeletons for Spinal Cord Injury (BASEGO)","BASEGO","Inclusion Criteria:\n\n* Age 14-65 years, any gender.\n* Clinical diagnosis of spinal cord injury (SCI) due to trauma, inflammation, tumor, vascular disease, or iatrogenic factors, confirmed by medical history, physical examination, and ancillary tests, resulting in lower limb motor dysfunction.\n* SCI diagnosed ≥6 months prior, with ≥1 month of continuous conventional rehabilitation (e.g., physical therapy, acupuncture, hydrotherapy, ≥3 hours daily) without significant improvement in motor function in the past 2 months.\n* ASIA Impairment Scale (AIS) grade A, B, or C based on the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).\n* Good general health with a life expectancy ≥12 months.\n* Mini-Mental State Examination (MMSE) score ≥22.\n* Educational attainment of secondary school or above.\n* Willingness to participate, provide informed consent, and comply with study follow-up.\n\nExclusion Criteria:\n\n* Presence of diseases other than spinal cord injury (SCI) that affect lower limb motor function, including brain diseases (e.g., brain tumor, stroke), lower limb vascular diseases (e.g., lower limb vascular occlusion), peripheral nerve diseases, or lower limb bone diseases (e.g., osteoarthritis, joint contracture).\n* Requires continuous medical interventions (e.g., tracheal intubation, nasogastric feeding) to maintain critical physiological functions (e.g., heartbeat, respiration, swallowing).\n* Congenital or acquired structural abnormalities of the lower limb bones or muscles.\n* Presence of surgical contraindications (e.g., anesthesia-related adverse reactions, coagulation risks, or surgeon's determination of unsuitability for surgery).\n* Presence of active implantable devices except for SCS or BCI devices (e.g., pacemakers, defibrillators, drug infusion pumps, cochlear implants, sacral nerve stimulators).\n* Unable to receive implantable devices due to other disease treatments or investigations, or requires magnetic resonance imaging (MRI) during the device implantation period.\n* MRI shows structural damage \\>50% in motor function areas (precentral and postcentral gyri, ventromedial sensorimotor areas, mid temporal lobe, Broca's area, Wernicke's area, Geschwind's area), or DTI shows damage \\>50% in the posterior limb of the internal capsule.\n* Severe cardiovascular disease: Above level II myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QTc interval ≥450 ms in men, ≥470 ms in women), level III-IV heart failure (NYHA classification), or echocardiography showing LVEF \\\u003C50%.\n* Coagulation abnormalities (INR \\>1.5 ULN, PT \\>ULN +4 s, or APTT \\>1.5 ULN), hemorrhagic tendency, or undergoing thrombolytic or anticoagulant therapy.\n* Severe infections within 4 weeks before surgery (requiring IV antibiotics, antifungals, or antivirals) or lumbar soft tissue infections, or unexplained fever \\>38.5℃ during screening or before surgery.\n* HIV infection, acquired immunodeficiency syndrome (AIDS), active tuberculosis, active hepatitis B (HBV DNA ≥500 IU\u002Fml), hepatitis C (positive HCV antibody and detectable HCV-RNA), or co-infection of hepatitis B and C.\n\nSevere cerebrovascular events (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, or pulmonary embolism within 12 months before enrollment.\n\n* Metastatic malignancies or untreated malignant tumors.\n* Major surgery or severe traumatic injuries, fractures, or ulcers within 4 weeks before enrollment.\n* Addictive habits such as drug abuse or alcoholism.\n* History of psychotropic drug abuse that is not controllable or presence of mental disorders, including major psychiatric illnesses (e.g., depression \\[BDI score \\>20\\], anxiety, obsessive-compulsive disorder, schizophrenia, autism, chronic sleep disorders, consciousness disorders).\n* Pregnant, breastfeeding, planning to conceive, or women of childbearing potential without reliable contraception.\n* Participation in other clinical trials within the past month.\n* Cognitive impairments or poor compliance from subjects, family members, or caregivers, or inability to complete at least 12 months of follow-up and rehabilitation training.\n* Other conditions that increase the risk of study participation or device use, as determined by the investigator.","14 Years",{"count":124,"type":21},3,[24],"The goal of this clinical trial is to evaluate the safety and technical feasibility of a novel brain-machine interface (BCI)-assisted spinal cord stimulation (SCS) and exoskeleton (EXS) system in patients with spinal cord injury (SCI). The primary aim is to determine whether the BCI-SCS-EXS system can safely and effectively improve lower limb motor function and quality of life in individuals with chronic SCI.\n\nParticipant Population:\n\nAdults aged 14-65 years (sex\u002Fgender not limited). Patients with chronic SCI (≥6 months post-injury) classified as ASIA A, B, or C.\n\nIndividuals with stable health status, MMSE ≥22, and secondary education or above.\n\nPrimary Questions:\n\n1. Is the BCI-SCS-EXS system safe and technically feasible for SCI rehabilitation?\n2. Does the system improve lower limb motor function and quality of life in SCI patients?\n\nInterventions:\n\nParticipants will undergo the following procedures:\n\nPhase I (Implantation):\n\nBCI implantation: ECoG electrodes placed over the motor cortex to decode lower limb movement intent.\n\nSCS electrode implantation: 5-6-5 paddle electrodes at T11-L2 for targeted spinal cord stimulation.\n\nPhase II (System Calibration):\n\nBCI-SCS synchronization: Calibration of decoded motor intent to trigger SCS parameters.\n\nSCS-EXO synchronization: Integration of SCS pulses with exoskeleton-assisted gait training.\n\nPhase III (Rehabilitation):\n\nDaily BCI-SCS-EXS training sessions (60 minutes, 5 times\u002Fweek for 1 year). Adaptive adjustments to stimulation parameters and exoskeleton support based on performance.\n\nRemote monitoring of device performance and emergency intervention for technical issues.\n\nOutcome Measures:\n\nPrimary: Safety (adverse events, device performance, synchronization metrics). Secondary: Efficacy (motor function, neurophysiological function, quality of life).\n\nEthics and Safety:\n\nInformed consent will be obtained from all participants. Adverse events will be monitored and reported according to CTCAE 5.0 guidelines.\n\nParticipant confidentiality will be strictly maintained. This study will provide foundational evidence for the safety and feasibility of the BCI-SCS-EXO system, paving the way for future randomized controlled trials in SCI rehabilitation.",[128,28,63,60,61,129,130,131,132,133],"Spinal Cord Injuries (SCI)","Spinal Cord Injury (Quadraplegia)","Motor Impairment","Motor Deficits","Gait Training","Gait Impairment",[135,136,137,138,139,140,141,142,143,144,145,146],"Brain-computer interface","Spianl cord stimulation","Exoskeleton","Rehabilitation","Spinal cord injury","Motor dysfunction","BCI","Brain-spinal interface","BSI","Brain-machine interface","Gait training","Neural plasticity","2025-05-14",{"date":149,"type":37},"2025-05-20",{"date":151,"type":37},"2025-04-23",{"date":153,"type":21},"2027-04-30",{"name":155,"class":44},"Xuanwu Hospital, Beijing"]