[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-spinal-cord-injury-sci\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-spinal-cord-injury-sci":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,74,104,138],{"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":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100649463","guided-laminectomy-with-augmented-duroplasty-for-acute-traumatic-spinal-cord-injury-100649463",false,"NCT07733401","Guided Laminectomy With Augmented Duroplasty for Acute Traumatic Spinal Cord Injury","Efficacy and Safety of Bony Decompression Combined With Dural Decompression Versus Isolated Bony Decompression for Acute Severe Traumatic Spinal Cord Injury: A Prospective, Multicenter, Randomized Controlled Trial","GLAD","Inclusion Criteria:\n\n1. Aged between 18 and 80 years old, with no restrictions on gender;\n2. Patients diagnosed with traumatic cervical or thoracic spinal cord injury (C2-T12) via clinical evaluation including medical history collection, physical examination and auxiliary imaging tests;\n3. Classified as Grade A, B or C according to the ASIA Impairment Scale (AIS) based on the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI);\n4. Scheduled to receive surgical intervention within 72 hours after traumatic spinal cord injury;\n5. Preoperative T2-weighted MRI shows no cerebrospinal fluid signal between the spinal cord and dura mater at a minimum of one vertebral segment;\n6. Good general physical condition with an expected survival time of no less than 12 months;\n7. Voluntarily participate in this trial, sign the written informed consent form, exhibit good compliance and cooperate with all follow-up visits;\n8. Judged by attending surgeons to meet the surgical indications for posterior laminectomy and spinal internal fixation, with surgical decision-making based on surgeons' clinical experience.\n\nExclusion Criteria:\n\n1. Transverse spinal cord injury;\n2. Gunshot or penetrating sharp spinal cord injury;\n3. Pre-existing dural laceration caused by traumatic spinal cord injury;\n4. Spinal cord injury without radiographic abnormality (SCIWORA, spinal injury without fracture or dislocation);\n5. Acute exacerbation of pre-existing chronic spinal cord injury;\n6. Traumatic spinal cord injury complicated with epidural or subdural hematoma;\n7. Severe concomitant traumatic brain injury defined as a Glasgow Coma Scale (GCS) score \\\u003C 14; patients unable to follow simple verbal commands due to altered mental status; or patients with clinically significant abnormalities on cranial CT (only patients with suspected brain injury identified by investigators require cranial CT scanning);\n8. Presence of underlying comorbidities that contraindicate surgery or interfere with accurate medical and neurological assessments (judged by the principal investigator).","ALL","18 Years","80 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to learn whether expansile duraplasty can improve neurological recovery in adult patients with acute severe traumatic spinal cord injury, as well as evaluate the safety of this surgical strategy. The main questions the study aims to answer are:\n\n1. Does expansile duraplasty lead to superior motor function recovery in patients with acute severe traumatic spinal cord injury?\n2. How safe is the use of expansile duraplasty in people with acute traumatic SCI?\n\nResearchers will compare neurological function, quality of life and all safety indicators who receive expansile duraplasty to that of participants who do not receive expansile duraplasty, to determine whether the additional expansile duraplasty provides better recovery benefits for patients with traumatic spinal cord injury.\n\nParticipants will be randomly assigned to one of two groups: the laminectomy combined with expansile duraplasty group and the laminectomy-only group. All participants will complete the following procedures:\n\n1. Receive standardized spinal surgery ;\n2. Provide blood and cerebrospinal fluid samples during hospitalization;\n3. Undergo spinal computed tomography (CT) and magnetic resonance imaging (MRI) scans at baseline (pre-operation), discharge, 3 months, 6 months and 12 months after surgery;\n4. Complete standardized neurological assessments at 3, 6 and 12 months postoperatively, including ASIA motor and sensory scores, Walking Index for Spinal Cord Injury II (WISCI II), and Spinal Cord Independence Measure III (SCIM III);\n5. Fill out questionnaires at each follow-up visit, including the 36-Item Short Form Health Survey (SF-36);\n6. Be continuously monitored for all adverse events and surgical complications throughout the 12-month follow-up period.",[28,29],"Spinal Cord Injury","Acute Spinal Cord Injury (SCI)",[31],"Acute Spinal Cord Injury","NOT_YET_RECRUITING","2026-07-24",{"date":35,"type":36},"2026-07-29","ACTUAL",{"date":38,"type":22},"2026-09",{"date":40,"type":22},"2029-09",{"name":42,"class":43},"Xuanwu Hospital, Beijing","OTHER",13,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100648453","phase-3-additional-phase-3-study-of-kp-100it-in-subjects-with-acute-spinal-cord-injury-100648453","NCT07722962","Additional Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury","An Additional Phase 3, Multicenter Study of Intrathecal Administration of KP-100IT in Subjects With Acute Spinal Cord Injury","Inclusion Criteria:\n\n* Patients whose AIS grade is A at 72 hours (± 6 hours) after injury\n* age: 18 years to 89 years\n* MRI imaging and other tests confirm the continuity of the spinal cord\n\nExclusion Criteria:\n\n* The injury site is C1-C2 or C2-C3\n* The patient with a spinal crd compression rate of 70% or higher.\n* The patient in whom a spinal cord rupture is strongle suspected.\n* The patient cannot start rehabilitation necessary for recovery of function at an early stage.\n* External trauma or concurrent organ injury.\n* High dose steroid therapy administered for the treatment of spinal cord injury\n* History or concurrent presence of malignant tumor.\n* It is inappropriate for the subject to be included in the study, in the opinion of the investigator.","89 Years",{"count":54,"type":22},10,[56],"PHASE3","This is a Phase 3, multicenter, open-label, single-arm additional study to evaluate the efficacy of intrathecal KP-100IT in patients with acute spinal cord injury. Eligible patients will receive KP-100 0.6 mg\u002Fbody by intrathecal administration once per week for a total of 5 doses and will be followed for approximately 24 weeks after the first dose.",[29],[60,61,62],"KP-100IT","Hepatocyte growth factor","Intrathecal administration","2026-07-20",{"date":65,"type":36},"2026-07-23",{"date":67,"type":22},"2026-07-31",{"date":69,"type":22},"2028-12-31",{"name":71,"class":72},"Kringle Pharma, Inc.","INDUSTRY",3,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":81,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100599898","safety-of-transcutaneous-electrical-stimulation-potentiating-recovery-in-acute-spinal-cord-injury-syndromes-100599898","NCT07090473","Safety of Transcutaneous Electrical Stimulation Potentiating Recovery in Acute Spinal Cord Injury Syndromes","STEP-RAISE","Inclusion Criteria:\n\nA subject will be eligible for enrollment in the study of the following criteria apply:\n\n1. Written informed consent is obtained.\n2. Acute traumatic cervicothoracic SCI that meets all of the following criteria:\n\n   1. Acute SCI presenting to the hospital within 12 hours of injury\n   2. Traumatic non-penetrating SCI\n   3. American Impairment Scale (AIS) Grade A, B, or C\n   4. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurological level of injury between C4 and T10\n3. Aged \\>\u002F=18 years\n4. Admission to Intensive Care Unite (ICU) with lumbar drain in place per standard of care\n\nExclusion Criteria:\n\nA subject will not be eligible for this study if ANY of the following criteria apply:\n\n1. Subjects classified as AIS D or E\n2. Penetrating SCIs or complete transection of the spinal cord\n3. Pregnancy\n4. Incarceration or police custody\n5. Class 2 or Class 3 obesity\n6. Any concomitant injury that, in the judgment of the Investigator, interferes with the procedures and examinations required by the study protocol, including but not limited to:\n\n   1. multiple spinal cord lesions\n   2. fractures requiring lower extremity casts or splints\n   3. skin breakdown or burns over the lumbar spine\n   4. profound hemodynamic instability\n   5. traumatic brain injury (defined by Glasgow Coma Scale (GCS) \\\u003C14 at enrollment or inability to participate in exam)","21 Years",{"count":83,"type":22},15,[25],"The goal of this study is to test whether electrical stimulation from the skin surface starting 3 days after spinal cord injury (SCI) is safe and may help patients recover their movement. The main questions it aims to answer are:\n\n* is starting electrical stimulation 3 days post SCI safe?\n* can starting electrical stimulation 3 days post SCI help patients recover movement?\n\nThis study will be done in two phases. Both phases will be done during the patient's stay in the hospital\u002Fintensive care unit (ICU).\n\nIn the first phase, participants' will undergo several tests before and after a single treatment. Assessments will be repeated before the patient will go home at around 7 days post injury.\n\n* assessment of the ability to move arms\u002Flegs and feel touch or pin prick\n* blood and cerebral spinal fluid draws\n* assessment of their spinal cord function using electrical stimulation\n* receive a single 60-minute continuous electrical stimulation treatment\n* patient's safety will be monitored throughout the intervention with the existing standard of care methods in the ICU settings.\n\nIn the second phase, researchers will compare active electrical stimulation to sham stimulation to see if active stimulation safely leads to improvement in person's movement ability.\n\nIn this second phase, participants' will undergo tests before and after electrical stimulation treatment which will be delivered 5 days in the row. Assessments will be repeated before the patient will go home at around 7 days post injury.\n\n* assessment of the ability to move arms\u002Flegs (every day) and feel touch or pin prick (before and after 5 days of treatment)\n* blood and cerebral spinal fluid draws (before the first treatment session and before going home)\n* assessment of their spinal cord function using electrical stimulation (before the first treatment session and before going home)\n* receive daily 60-minute continuous electrical stimulation treatment for 5 days while in ICU\n* patient's safety will be monitored throughout the intervention with the existing standard of care methods in the ICU settings.",[29,87],"Acute Spinal Cord Injury of Traumatic Origin (tSCI)",[89,90,91,92],"acute spinal cord injury","transcutaneous spinal cord stimulation","acute rehabilitation","acute traumatic spinal cord injury","RECRUITING","2026-06-03",{"date":96,"type":36},"2026-06-04",{"date":98,"type":36},"2026-04-10",{"date":100,"type":22},"2028-06-30",{"name":102,"class":43},"University of California, San Francisco",1,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":118,"conditions":119,"keywords":120,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100568131","phase-1-phase-1b2a-clinical-trial-to-determine-the-safety-tolerability-and-efficacy-of-tz-161-in-spinal-cord-injury-100568131","NCT06677229","Phase 1b\u002F2a Clinical Trial to Determine the Safety, Tolerability and Efficacy of TZ-161 in Spinal Cord Injury","Phase 1b\u002F2a Clinical Trial in Early Acute Spinal Cord Injury (SCI): a Single Blinded, Randomized, Proof-of-Concept Study to Determine the Safety, Tolerability and Efficacy of TZ-161","eSpine","Inclusion Criteria:\n\n1. Subjects aged 18-65 years old.\n2. Subjects with clinical diagnosis of acute SCI that comply with the following:\n\n   1. Injury located on the thoracic region (T1 to T12).\n   2. With clinical suspicion of a single traumatic (contusion) lesion.\n   3. AIS grade of grade B, C or D with a motor score less than or equal to 3 in at least one key muscle of a lower limb.\n   4. Ability to perform injury-to-drug administration ≤ 24 hours after SCI.\n3. Subjects willing and able to provide an informed consent.\n4. Subjects willing and able to complete the study and comply with instructions. The use of Relert in the elderly is not recommended, due to the fact that the safety and effectiveness of Eletriptan HBr in patients over 65 years of age had not been systematically evaluated, as a consequence of the small number of patients in this age group in clinical trials.\n\nExclusion Criteria:\n\n1. Clinical or imaging suspicion of multi-lesion or extra-thoracic contusions on diagnostic CT scan and on MRI at 48H\\*.\n2. Subjects in coma or with significant cognitive impairment in the opinion of the investigator.\n3. Subjects presenting mechanical ventilation dependence.\n4. Subjects with past medical history of any - structural - neurological disorder of the central or peripheral nervous system, including past spinal cord injury. Furthermore, subjects with spine\u002Fbone-related medical history (prior to SCI) that in the opinion of the investigator are not yet resolved or previous lesions that are located in the same area of the study SCI should also be excluded.\n5. Subjects with dysphagia or inability to swallow tablets.\n6. Women who are breastfeeding or who are pregnant. Pregnancy to be excluded during screening by presence of a negative blood pregnancy test.\n7. Subjects with active malignancy, or malignancy in the last 5 years if subject is currently undergoing treatment with prohibited medication.\n8. Subjects that have recently used Eletriptan HBr (within the last 24h).\n9. Subjects presenting clinically significant ECG abnormalities (Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders) at screening.\n10. Subjects presenting any contraindications, special warnings, and precautions regarding IMP administration, as per described in the SmPC of Eletriptan HBr:\n\n    1. Ischemic CAD, such as angina pectoris, history of myocardial infarction, and documented silent ischemia, or coronary artery vasospasm, including Prinzmetal's angina.\n    2. Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders.\n    3. History of stroke, TIA, or history or current evidence of hemiplegic or basilar migraine because these patients are at a higher risk of stroke.\n    4. Peripheral vascular disease.\n    5. Ischemic bowel disease.\n    6. Uncontrolled hypertension.\n    7. Recent use (i.e., within 24 hours) of serotonin receptor agonists\n    8. Coadministration with SSRIs, SNRIs, TCAs, and MAO due to risk of serotonin syndrome.\n    9. Recent use (i.e., within 24 hours) of drugs containing ergotamine or ergot-like substances (such as dihydroergotamine or methysergide)\n    10. Hypersensitivity to IMP and its excipients (angioedema and anaphylaxis seen).\n11. The following medications and\u002For substances are not allowed due to potential interaction with Eletriptan HBr or inhibition of the CYP3A4 system (recent use, i.e., within at least 72 hours):\n\n    1. Cimetidine; ketoconazole; itraconazole; fluconazole, erythromycin; clarithromycin, troleandomycin, verapamil, and MAO inhibitors \\[such as isocarboxazid (Marplan), phenelzine sulfate (Nardil), tranylcypromine (Parmate), selegiline (Emsam)\\], pioglitazone, and valerian.\n    2. Antiretrovirals - such as ritonavir, indinavir, nelfinavir, efavirenz and nevirapine.\n    3. Other prohibited concomitant medications include haloperidol, trazodone, triazolam, nefazodone, diltiazem, carbamazepine, phenytoin, oxcarbazepine, and phenobarbital.\n    4. St. John's Wort (Hypericum perforatum).\n12. Subjects with known liver disease (except for Child Pugh A) or severe hepatic impairment.\n13. Subjects with known renal disease or severe renal impairment - exclude if eGFR below 50 ml\u002Fmin.\n14. Subjects that have participated in any other study in the last 3 months or plan to participate in another study at any time during this clinical trial.\n15. Subjects that have foreign magnetic metal bodies or other conditions that render them unable to perform MRI.\n16. Any other issue that, in the opinion of the investigator, makes the subject unsuitable for study participation.","65 Years",{"count":114,"type":22},28,[116,117],"PHASE1","PHASE2","Technophage identified a promising compound, Eletriptan hydrobromide, that intends to use as a repurposed drug, for the treatment of acute spinal cord injury (SCI) in human subjects. Eletriptan hydrobromide is a well characterized molecule, that has been clinically available for over two decades for the treatment of migraines. It presents a good and manageable safety profile, including for the regimen selected for this trial, and it is generally well tolerated, with minimal side effects. This is an important consideration to have when using repurposed drugs for the treatment of other indications. Technophage believes that the preclinical data collected, in combination with the acceptable safety profile of Eletriptan hydrobromide, support its use as a repurposed drug for the treatment of SCI in humans.",[29],[89,121,122,123,124,125,126,127],"TZ-161","Eletriptan Hydrobromide","Eletriptan HBr","serotonin receptor","5-HT receptor","Relert","Relpax","2025-09-02",{"date":130,"type":36},"2025-09-09",{"date":132,"type":36},"2025-08-01",{"date":134,"type":22},"2027-06",{"name":136,"class":72},"Technophage, SA",2,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":23,"phases":149,"briefSummary":150,"conditions":151,"keywords":158,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":168,"locationsCount":170},"100578921","phase-1-ng004-in-spinal-cord-injury-patients-100578921","NCT06817577","NG004 in Spinal Cord Injury Patients","A First-in-human (FIH) Clinical Trial to Investigate the Human Monoclonal Antibody NG004, Administrated Intrathecally in Acute Spinal Cord Injury (SCI) Patients","SPROUT","Inclusion Criteria:\n\n* Acute incomplete cervical SCI (Neurological level of injury C1 ≤ lesion ≤ C8) with confirmed classification of American Spinal Injury Association (ASIA) impairment scale (AIS) C-D at Screening\n* 4-28 days post-injury\n* No required mechanical ventilation or patients that not completely depend on mechanical ventilation\n* Hemodynamically and clinical stable patient according to the acute SCI condition at baseline\n\nExclusion Criteria:\n\n* Trauma caused by ballistic or other injury that directly penetrates the spinal cord including gunshot and knife wounds\n* Multiple levels of clinically relevant spinal cord lesions\n* Major brachial or lumbar plexus damage\u002Ftrauma\n* Significant head trauma or other injury that was, in the opinion of the investigator, sufficient to interfere with the assessment of the spinal cord function\n* Other significant pre-existing or current severe systemic disease such as lung, liver (exception: history of uncomplicated Hepatitis A), gastrointestinal, cardiac, immunodeficiency (including anamnestic known HIV) or kidney disease; or active malignancy\n* History of or an acute episode of Multiple Sclerosis or Guillain-Barre syndrome History of recent (6 months) meningitis or meningoencephalitis\n* History of refractory epilepsy\n* History of or current autoimmune disease\n* Patients with uncontrolled bleeding diathesis and\u002For who require concomitant therapeutic anticoagulation and not related to SCI\n* Presence of any unstable medical or psychiatric condition\n* Drug dependence any time during the 6 month's preceding trial entry\n* Pregnant or nursing women\n* History of a life-threatening allergic or immune mediated reaction\n* Patients with the presence of infection around the location where the spinal needle insertions are planned for applying the intrathecal injections\n* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations\n* Patients who are unconscious","70 Years",{"count":148,"type":22},21,[116],"This is the FIH, multicenter, open-label, sequential, multiple ascending dose trial of NG004 in patients with acute incomplete cervical SCI. The trial will evaluate the safety, tolerability, and PK of 4 dose regimens of NG004, and will evaluate the maximum tolerated dose of NG004.",[29,152,153,154,155,156,157],"Spinal Cord Diseases","Central Nervous System Diseases","Nervous System Diseases","Trauma, Nervous System","Spinal Cord Injuries (SCI)","Wounds and Injuries",[159,160,144,161],"Acute spinal cord injury","Nogo-A","Regeneration","2025-02-04",{"date":164,"type":36},"2025-02-10",{"date":166,"type":36},"2024-12-18",{"date":38,"type":22},{"name":169,"class":72},"NovaGo Therapeutics AG",6]