[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"traumatic-spinal-cord-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:traumatic-spinal-cord-injury":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,50,75,107,134],{"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":26,"conditions":27,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100638318","phase-2-pilot-study-of-galantamine-to-treat-metabolic-syndrome-in-people-with-chronic-traumatic-spinal-cord-injury-sci-100638318",false,"NCT07625332","Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)","Pilot Study of Tolerability and Preliminary Efficacy of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)","Inclusion Criteria:\n\n* Adults aged 21-75 years (male or female)\n* Chronic (≥1 year post injury) traumatic non-progressive spinal cord injury (SCI)\n* Wheelchair user for community mobility\n* Injury level of tetraplegia (cervical level) or paraplegia (all levels)\n* SCI-specific obesity indicated by waist circumference ≥94 cm\n* Resting heart rate \\>45 bpm based on 10 measurements over 10 minutes\n* Without clinically significant cardiovascular abnormalities as indicated by 12-lead ECG\n* Tolerable bowel routine indicated by a score of \\\u003C10 on the International SCI Bowel Function Data Set (ISCI-BDS)\n* Metabolic Syndrome (MetS) defined by the presence of at least three of the following: (1) obesity indicated by SCI-specific waist circumference ≥94 cm, (2) elevated fasting glucose ≥100 mg\u002FdL, (3) dyslipidemia: high triglycerides ≥150 mg\u002FdL or low HDL cholesterol \\\u003C40 mg\u002FdL for men and \\\u003C50 mg\u002FdL for women, (4) C-reactive protein (CRP) levels \\>1 mg\u002FdL\n* Able to understand and communicate in English at the level of describing adverse event frequency and severity and completing validated outcome measures\n* Willingness to comply with all study procedures and availability for the duration of the study\n* Provision of signed and dated informed consent form\n\nExclusion Criteria:\n\n* Diagnosis of neurological injury or condition other than SCI\n* Progressive condition that would be expected to change neurological status\n* Signs and symptoms of cardiovascular disease or cardiac arrhythmias\n* Resting heart rate \\\u003C45 bpm\n* Score of 10 or greater on the ISCI-BDS v2.1 indicating moderate to severe neurogenic bowel dysfunction\n* Severe concurrent medical disease, condition, or illness judged to be contraindicated by the site physician\n* Psychopathology documented in the medical record or history that may conflict with study objectives\n* Pregnancy (participant reported or determined by clinical lab test), women who plan to become pregnant, or women who are nursing during the study\n* Active cancer or currently in treatment for cancer\n* Triglyceride levels ≥400 mg\u002FdL\n* Chronic use of medications with known or probable interactions with galantamine\n* Enrolled in another research study that is likely to interfere with conduct or results of the current study\n* Any other reason the site physician feels that participation is contraindicated","ALL","21 Years","75 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","The purpose of this research study is to measure the tolerability and preliminary efficacy of a drug, galantamine, to treat metabolic syndrome (MetS) by reducing circulating inflammation in people with spinal cord injury (SCI). Galantamine is FDA-approved for the treatment of Alzheimer's disease. Here, the drug is considered experimental for the purposes of this study.",[28,29,30,31],"Spinal Cord Injury","Traumatic Spinal Cord Injury","Paraplegia and Tetraplegia","Metabolic Syndrome",[33,34,35,36],"spinal cord injury","tetraplegia","paraplegia","metabolic syndrome","RECRUITING","2026-05-28",{"date":40,"type":41},"2026-06-04","ACTUAL",{"date":43,"type":21},"2026-06-15",{"date":45,"type":21},"2027-12",{"name":47,"class":48},"Northwell Health","OTHER",3,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100638479","delayed-versus-early-surgical-decompression-for-traumatic-spinal-cord-injury-100638479","NCT07583836","DELAYED VERSUS EARLY SURGICAL DECOMPRESSION FOR TRAUMATIC SPINAL CORD INJURY","COMPARISON OF DELAYED VERSUS EARLY SURGICAL DECOMPRESSION FOR TRAUMATIC SPINAL CORD INJURY","Inclusion Criteria:\n\n* Patients presenting with spinal cord injury (both cervical and thoracic) as per described in the operational definition\n* Age from 18-60 years\n* Both male and female patients\n\nExclusion Criteria:\n\n* Patients with penetrating spinal injuries such as gunshot\u002Fstab wounds\n* Patients with pre-existing neurological conditions like myelopathy etc.\n* Patients with any kind of malignancy\n* Patients having CSF infection etc.\n* Patients who are not fit for general anesthesia (i.e. ASA Grade \\>2 Annexure-B)\n* Diagnosis of subclinical or clinical polyneuropathy\n* Non-traumatic or pathological fractures or cord compression\n* Inability to cooperate with preoperative physical examination because of cognitive impairment\n* Patients with previous spinal column or SCI.","18 Years","60 Years",{"count":60,"type":21},100,"OBSERVATIONAL","To compare the outcome of early versus delayed surgical decompression among patients presenting with traumatic spinal cord injury in a tertiary care hospital.",[29],[29],"2026-05-07",{"date":67,"type":41},"2026-05-13",{"date":69,"type":41},"2025-08-30",{"date":71,"type":21},"2026-06-01",{"name":73,"class":48},"Fauji Foundation Hospital",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":74},"100556048","evaluating-safety-and-feasibility-of-transcutaneous-spinal-cord-stimulation-following-traumatic-and-non-traumatic-spinal-cord-injury-a-pilot-study-100556048","NCT06520020","Evaluating Safety and Feasibility of Transcutaneous Spinal Cord Stimulation Following Traumatic and Non-Traumatic Spinal Cord Injury: A Pilot Study","STIM","Inclusion Criteria:\n\n* Age: = 18 years and = 80 years.\n* Written informed consent by patient and\u002For legal authorized representative (LAR).\n* No other life-threatening condition.\n* No evidence of sepsis.\n* No evidence of superficial skin infection at site of surgery and intervention.\n* An established diagnosis of either:\n\n  * cervical myelopathy with modified Japanese Orthopaedic Association score of 8-14, or\n  * acute cervical \u002F thoracic SCI with ASIA Impairment Scale grade A-D (as assessed within 72 hours of injury) with neurologic level of injury (NLI) from C2 to T12.\n* The ability to undergo, or have had, surgical intervention. -. The ability to undergo transcutaneous intervention including study procedures in the posterior cervical or thoracic midline at or after 14 days from surgery.\n\nExclusion Criteria:\n\n* Any concomitant impairment of the upper and lower limb at baseline that could potentially confound the neurologic assessments; including but not limited to traumatic or disease conditions like brachial plexus injury, peripheral neuropathy, spinal hematoma, transverse myelitis, non-compressive myelopathy, dementia, and Parkinson's disease.\n* mJOA of \\>= 15 and \\\u003C= 7, or AIS grade E tSCI at baseline assessment.\n* Currently involved in another non-observational ntSCI or tSCI study, or receiving another interventional drug, that could interfere with recordings and confound adverse events.\n* Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation, at discretion of the treating surgeon and\u002For principal investigator.\n* Unable to commit to the follow-up schedule.\n* Recent history of regular substance abuse (illicit drugs, alcohol), which in the opinion of the investigator would interfere with the subject's participation in the study.\n* Any condition likely to result in the patient's death within the next 12 months.\n* Prisoner.\n* Pregnancy.\n* Cardiac pacemaker dependent, unable to undergo electrical stimulation.\n* Brain implant, skull prosthesis, plate and screws limiting transcranial stimulation.\n* Tattoo at site of skin electrode that causes heat\u002Fpain during stimulation.\n* Subjects who in the opinion of the investigator are not suitable for inclusion in the study, with reason documented.","80 Years",{"count":84,"type":21},30,[86],"NA","The study will be a non-randomized, non-blinded pilot study to analyze the safety and feasibility of a non-significant risk device, transcutaneous spinal cord stimulation. The aim is to include 30 total patients, 10 patients in each of 3 groups:\n\n1. Non-traumatic spinal cord injury (ntSCI) with diagnosis of degenerative cervical myelopathy and offered surgical intervention.\n2. Early tSCI screened during the hospital admission when cervical\u002Fthoracic spinal injury was diagnosed.\n3. Delayed tSCI (control) screened 6-24 months after acute cervical\u002Fthoracic spinal injury.",[89,90,29,91],"Spinal Cord Stimulation","Electric Stimulation Therapy","Cervical Myelopathy",[93,94,95,96,97],"Stimulation","Transcutaneous","MagStim","Transcranial","Magnetic","2025-06-05",{"date":100,"type":41},"2025-06-06",{"date":102,"type":41},"2024-10-23",{"date":104,"type":21},"2026-06-30",{"name":106,"class":48},"Francis Farhadi",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":118,"conditions":119,"keywords":120,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":74},"100559483","phase-4-early-pharmacological-treatment-of-acute-spasticity-after-spinal-cord-injury-100559483","NCT06564714","Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury","Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury to Promote Long-term Neurofunctional Recovery: a Randomized Clinical Trial","Inclusion Criteria:\n\n* Male or female aged 18 years or older\n* Blunt (non-penetrating) traumatic SCI\n* AIS grade A to D\n* NLI between C0 and L1\n* Patient willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Non-traumatic SCI (e.g. tumor, infection, transverse myelitis, etc.)\n* AIS grade E upon admission\n* Penetrating tSCI (from stab wound, gunshot injury, etc.)\n* Cauda equina syndrome or NLI below L1\n* Moderate or severe brain injury (mild traumatic brain injury not an exclusion criteria)\n* Contraindication to oral baclofen use (needs clearance from attending physician and pharmacological consultant)\n* Pre-existing neurological disorders (cerebrovascular disease, Parkinson's disease, multiple sclerosis, etc.)\n* Major cognitive deficits precluding informed consent and\u002For assessments\n* Unlikely to comply with scheduled visits (e.g. living in another country)\n* Renal insufficiency",{"count":115,"type":21},55,[117],"PHASE4","The objective of this clinical trial is to evaluate if early detection of spasticity and immediate treatment with oral baclofen during acute care prevents problematic spasticity and improves neurofunctional recovery after tSCI.\n\nThe main questions it aims to answer are :\n\n1. Assess the safety of early baclofen treatment during acute care after SCI.\n2. Compare the neurofunctional outcomes between the early baclofen group and the control group up to 6 months after tSCI, in terms of mobility, global functional independence, neurological recovery, pain and spasticity.\n\nThe early baclofen group will receive oral administration of baclofen as soon as any sign of acute spasticity is observed. The dose is started initially at 5 mg three times a day and is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response, i.e. when spasticity is no longer problematic. The control group however will receive the \"usual routine care\" at our institution as per which baclofen is initiated by the attending physician (i.e. physiatrist or spine surgeon) only when acute spasticity becomes severe and problematic.",[29],[121,28,122,123],"Trauma","Baclofen","Spasticity","NOT_YET_RECRUITING","2024-08-19",{"date":127,"type":41},"2024-08-21",{"date":129,"type":21},"2024-12",{"date":131,"type":21},"2029-06",{"name":133,"class":48},"Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":74},"100516136","safety-feasibility-and-efficacy-of-tscs-on-stabilizing-blood-pressure-for-acute-inpatients-with-sci-100516136","NCT06000592","Safety, Feasibility, and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With SCI","Safety, Feasibility, and Efficacy of Transcutaneous Spinal Cord Stimulation on Stabilizing Blood Pressure for Acute Inpatients With Spinal Cord Injury","Inclusion Criteria:\n\n* Newly injured patients with traumatic SCI\n* Admitted to Acute Inpatient Rehabilitation at Mount Sinai\n* Within one year of SCI\n* Seated hypotension (systolic BP ≤ 110 mmHg for males or ≤ 100 mmHg for females)\n* Orthostatic hypotension (fall in systolic BP ≥ 20 mmHg and\u002For a fall in diastolic BP ≥ 10 mmHg within 10 minutes of assuming an upright position)\n* Daily fluctuation in systolic BP ≥ 20 mmHg and\u002For fluctuation in diastolic BP ≥ 10 mmHg\n* At least 14 years old\n\nExclusion Criteria:\n\n* Implanted brain\u002Fspine\u002Fnerve stimulators\n* Cochlear implants\n* Cardiac pacemaker\u002Fdefibrillator, or intracardiac lines\n* Open skin lesions on or near the electrode placement sites (neck, upper back)\n* Significant coronary artery or cardiac conduction disease\n* Recent history of myocardial infarction\n* Insufficient mental capacity to understand and independently provide consent\n* Pregnancy\n* Cancer\n* Deemed unsuitable by study physician","14 Years","100 Years",{"count":144,"type":21},50,[86],"Current forms of pharmacologic and non-pharmacologic treatments for hypotension and orthostatic hypotension (OH) remain inadequate during acute inpatient rehabilitation (AIR) following a traumatic spinal cord injury (SCI). A critical need exists for the identification of safe, practical, and effective treatment options that stabilize blood pressure (BP) after traumatic SCI. Recent published evidence suggests that transcutaneous Spinal Cord Stimulation (TSCS) can be used to raise seated BP, and mitigate the falls in BP during orthostatic repositioning in individuals with chronic SCI. This site-specific project will focus on the use of TSCS to stabilizing seated BP and mitigate the fall in BP during orthostatic repositioning during AIR following traumatic SCI.",[148,149,150,29,89,151,152,153],"Acute Spinal Cord Injury","Spinal Cord Injuries","Neuromodulation","SCI - Spinal Cord Injury","Blood Pressure","Blood Pressure Disorders","2024-04-01",{"date":156,"type":41},"2024-04-02",{"date":158,"type":41},"2022-01-01",{"date":160,"type":21},"2026-10-01",{"name":162,"class":163},"Jill M. Wecht, Ed.D.","FED"]