[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-traumatic-spinal-cord-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-traumatic-spinal-cord-injury":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100534775","spinal-decompression-plus-nerve-graft-implantation-following-tsci-100534775",false,"NCT06243211","Spinal Decompression Plus Nerve Graft Implantation Following TSCI","Minimizing Secondary Injury in Patient With SCI Using Expansive Duroplasty","Inclusion Criteria:\n\n* Age: = 18 years and = 80 years\n* Written informed consent by patient or legal authorized representative\n* No other life-threatening injury\n* No evidence of sepsis\n* Acute cervical or thoracic SCI with ASIA Impairment Scale grade A or B on admission\n* Non-penetrating SCI at neurologic level from C2 to C8 or T1 to T12\n* The ability to undergo surgical intervention including study procedures through a posterior approach within 48 hours of injury\n\nExclusion Criteria:\n\n* Unconsciousness or other mental impairment that prevents neurological assessment within the first 48 hours\n* Acute SCI with ASIA Impairment Scale grade C, D or E\n* Spinal cord decompression and spinal stabilization can be safely performed through an anterior-only approach (i.e. posterior approach is not required)\n* Currently involved in another non-observational SCI research study or receiving another investigational drug\n* Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation (at discretion of the principal investigator)\n* Unable to commit to the follow-up schedule\n* A 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* Subjects who in the opinion of the investigator are not suitable for inclusion in the study (reason to be documented).\n* Pregnancy","ALL","18 Years","80 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a single-blinded (with outcome assessors blinded to treatment allocation), 12-month pilot study to evaluate of the safety, feasibility, and preliminary efficacy of dorsal myelotomy and expansive duraplasty performed either without or with autologous nerve graft implantation after acute traumatic spinal cord injury.\n\nTen participants will be allocated to receive either DMED (n=5) or DMED + ANGI (n=5) based on a block design. Participants and assessors will be blinded to group allocation. Excess sural nerve samples will be collected for banking\u002Fanalysis (may include proteomic, culturing, genomic, cellular analysis).",[27,28],"Spinal Cord Injuries","Acute Traumatic Spinal Cord Injury",[30,31,32,33,34],"Decompression","Dorsal","Duraplasty","Myelotomy","Nerve Graft","RECRUITING","2025-12-03",{"date":38,"type":39},"2025-12-10","ACTUAL",{"date":41,"type":39},"2024-04-19",{"date":43,"type":21},"2026-12-31",{"name":45,"class":46},"Francis Farhadi","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":67,"locationsCount":69},"100398895","neurowave---extracorporeal-shock-wave-therapy-eswt-in-acute-traumatic-complete-ais-a-and-incomplete-ais-b-d-cross-sectional-lesions-on-motor-and-sensory-function-within-six-months-after-injury-100398895","NCT04474106","NEUROwave - Extracorporeal Shock Wave Therapy (ESWT) in Acute Traumatic Complete (AIS A) and Incomplete (AIS B-D) Cross-sectional Lesions on Motor and Sensory Function Within Six Months After Injury","The Effect of Extracorporeal Shock Wave Therapy (ESWT) in Acute Traumatic Complete (AIS A) and Incomplete (AIS B-D) Cross-sectional Lesions on Motor and Sensory Function Within Six Months After Injury: A Two-arm Three-stage Adaptive, Prospective, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial","Inclusion Criteria:\n\n* Patients with acute traumatic spinal injuries who are awake, responsive, and oriented at admission\n* Patients from the age of 18 years\n* Admission to hospital within 24 hours after injury\n* Written consent to participate in the study\n* Participation in the Austrian Spinal Cord Injury Study (ASCIS)-Registry (only for the Austrian hospitals)\n\nExclusion Criteria:\n\n* Patients who cannot cooperate or are not capable to give consent to participate\n* Serious traumatic brain injuries that prevent accurate participation in study procedures and\u002For adequacy of informed consent Participation in other interventional clinical trials\n* Serious concomitant injuries that prevent the neurological initial assessment\n* Preexisting neurological conditions that affect the primary endpoint of the study and potentially mask or reduce the therapeutic effect of the ESWT application\n* High dose administration of corticosteroids\n* Complete spinal cord transection\n* Patients with pacemakers or implantable defibrillators\n* Patients who are using devices which are sensitive to electromagnetic radiation\n* (potential) Pregnancy\n* Patients with tumors\n* Patients with severe coagulation disorders","99 Years",{"count":57,"type":21},246,[24],"It has been hypothesized that there are two mechanisms of acute traumatic spinal cord injury (SCI): the primary mechanical damage and the secondary injury due to additional pathological processes initiated by the primary injury. Neurological damage due to laceration, contusion, distraction or compression of the spinal cord is called ''primary injury''. This mechanical injury leads to a cascade of biochemical and pathological changes, described as ''secondary injury'', which occurs minutes to weeks after the initial trauma and causes further neurological deterioration. This secondary cascade involves vascular changes, an inflammatory response, neurotoxicity, apoptosis and glial scarring, and further compromises neurological impairment after traumatic spinal cord injury. Edema, ischemia and loss of autoregulation continue to spread bi-directionally from the initial lesion along the spinal cord for up to 72 hours after the trauma.\n\nIt has been postulated that the damage caused by the primary injury mechanism is irreversible and therapeutic approaches in recent years have focused on modulating the secondary injury cascade.\n\nResearchers found significantly greater numbers of myelinated fibers in peripheral nerves after a single ESWT application in an experimental model on rats after a homotopic nerve autograft into the sciatic nerve.\n\nIn another study a spinal cord ischemia model in mice was performed. ESWT was applied immediately after surgery and the treated animals showed a significantly better motor function and decreased neuronal degeneration compared to the control group within the first 7 days after surgery.\n\nResearchers investigated the effect of low-energy ESWT for the duration of three weeks on a thoracic spinal cord contusion injury model in rats. Animals in the ESWT group demonstrated significantly better locomotor improvement and reduced neuronal loss compared to the control animals at 7, 35, and 42 days after contusion.\n\nIt has been postulated previously, that ESWT improves the metabolic activity of various cell types and induces an improved rate of axonal regeneration.\n\nESWT might be a promising therapeutic strategy in the treatment of traumatic SCI.\n\nThe underlying study aims to investigate the effect of ESWT after acute traumatic spinal cord injury in humans within 48 hours of trauma in order to intervene in the secondary injury phase with the objective to reduce the extent of neuronal damage.",[28],"2024-01-31",{"date":63,"type":39},"2024-02-01",{"date":65,"type":39},"2020-07-02",{"date":43,"type":21},{"name":68,"class":46},"AUVA",15]