[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100398895":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":202,"collaborators":26,"id":205,"slug":206,"hasResults":207,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":26,"eligibilityCriteria":211,"healthyVolunteers":207,"sex":212,"minAge":213,"maxAge":214,"enrollmentInfo":215,"targetDuration":26,"studyType":218,"phases":219,"briefSummary":221,"conditions":222,"keywords":26,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":233},{"fullName":5,"class":6},"AUVA","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ESWT","EXPERIMENTAL","The extracorporeal shockwave therapy is applied once at the level of lesion and 5 segments above and below; or below the occiput (in lesions higher than C6) and above the sacrum (in lesions lower than T12). In addition, the ESWT is applied to the soles of both feet on the medial side of the plantar surface. The ESWT is applied as soon as possible within 48 hours post-injury.",[13],"Device: Shock waves",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","SHAM_COMPARATOR","In the control group, the same procedure is performed, but without the device emitting extracorporeal shock waves using a dummy head.",[19],"Device: dummy head",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Shock waves","The shockwave generator orthogold 100® generates high-energy acoustic waves that behave much like other sound waves except that they have much greater pressure and energy. As with sound waves, Spark Waves® can easily travel great distance as long as the acoustic impedance stays the same.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"dummy head","The shockwave generator orthogold 100® will be used in combination with a dummy head, to Refrain shock waves",[15],[32],{"name":33,"affiliation":5,"role":34},"Wolfgang Schaden, Dr.","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Wolfgang Schaden, Dr","CONTACT","0043 5 9393 20170","wolfgang.schaden@auva.at",{"name":42,"role":38,"phone":26,"phoneExt":26,"email":43},"Iris Leister, MSc","iris.leister@pmu.ac.at",[45,64,74,86,98,104,116,125,137,149,156,165,177,186,192],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Medical University Innsbruck","RECRUITING","Innsbruck","Tyrol","6020","Austria","AT",{"type":54,"coordinates":55},"Point",[56,57],11.39454,47.26266,{"lat":57,"lon":56},[60,62],{"name":61,"role":38,"phone":26,"phoneExt":26,"email":26},"Richard Lindtner, Dr",{"name":63,"role":38,"phone":26,"phoneExt":26,"email":26},"Rene Schmid, Dr.",{"facility":65,"status":66,"city":67,"state":26,"zip":68,"country":51,"countryCode":52,"cosmosGeoPoint":69,"geoPoint":73,"contacts":26},"Rehazentrum Bad Häring","ACTIVE_NOT_RECRUITING","Bad Häring","6323",{"type":54,"coordinates":70},[71,72],12.11912,47.51071,{"lat":72,"lon":71},{"facility":75,"status":47,"city":76,"state":26,"zip":77,"country":51,"countryCode":52,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Landeskarnkenhaus Feldkirch","Feldkirch","6807",{"type":54,"coordinates":79},[80,81],9.59734,47.23645,{"lat":81,"lon":80},[84],{"name":85,"role":38,"phone":26,"phoneExt":26,"email":26},"Rene El-Attal, Prim",{"facility":87,"status":47,"city":88,"state":26,"zip":89,"country":51,"countryCode":52,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Unfallkrankenhaus Graz","Graz","8020",{"type":54,"coordinates":91},[92,93],15.44197,47.06733,{"lat":93,"lon":92},[96],{"name":97,"role":38,"phone":26,"phoneExt":26,"email":26},"Michael Plecko, Prim",{"facility":99,"status":66,"city":88,"state":26,"zip":100,"country":51,"countryCode":52,"cosmosGeoPoint":101,"geoPoint":103,"contacts":26},"Rehazentrum Tobelbad","8144",{"type":54,"coordinates":102},[92,93],{"lat":93,"lon":92},{"facility":105,"status":47,"city":106,"state":26,"zip":107,"country":51,"countryCode":52,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Unfallkrankenhaus Klagenfurt","Klagenfurt","9020",{"type":54,"coordinates":109},[110,111],14.30528,46.62472,{"lat":111,"lon":110},[114],{"name":115,"role":38,"phone":26,"phoneExt":26,"email":26},"Rudolf Pranzl, Prim.",{"facility":117,"status":66,"city":118,"state":26,"zip":119,"country":51,"countryCode":52,"cosmosGeoPoint":120,"geoPoint":124,"contacts":26},"Rehazentrum Weißer Hof","Klosterneuburg","3400",{"type":54,"coordinates":121},[122,123],16.32522,48.30521,{"lat":123,"lon":122},{"facility":126,"status":47,"city":127,"state":26,"zip":128,"country":51,"countryCode":52,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Unfallkrankenhaus Linz","Linz","4010",{"type":54,"coordinates":130},[131,132],14.28611,48.30639,{"lat":132,"lon":131},[135],{"name":136,"role":38,"phone":26,"phoneExt":26,"email":26},"Klaus Katzensteiner, Prim.",{"facility":138,"status":47,"city":139,"state":26,"zip":140,"country":51,"countryCode":52,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Unfallkrankenhaus Salzburg","Salzburg","5010",{"type":54,"coordinates":142},[143,144],13.04399,47.79941,{"lat":144,"lon":143},[147],{"name":148,"role":38,"phone":26,"phoneExt":26,"email":26},"Arnold Suda, Prim.",{"facility":150,"status":151,"city":139,"state":26,"zip":152,"country":51,"countryCode":52,"cosmosGeoPoint":153,"geoPoint":155,"contacts":26},"Universitätsklinik für Orthopädie und Traumatologie","WITHDRAWN","5020",{"type":54,"coordinates":154},[143,144],{"lat":144,"lon":143},{"facility":157,"status":151,"city":158,"state":26,"zip":159,"country":51,"countryCode":52,"cosmosGeoPoint":160,"geoPoint":164,"contacts":26},"Unfallkrankenhaus St. Pölten","Sankt Pölten","3100",{"type":54,"coordinates":161},[162,163],15.63725,48.20762,{"lat":163,"lon":162},{"facility":166,"status":47,"city":167,"state":26,"zip":168,"country":51,"countryCode":52,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Universitätsklinik Wien, AKH","Vienna","1090",{"type":54,"coordinates":170},[171,172],16.37208,48.20849,{"lat":172,"lon":171},[175],{"name":176,"role":38,"phone":26,"phoneExt":26,"email":26},"Stefan Hajdu, Prof.",{"facility":178,"status":47,"city":167,"state":26,"zip":179,"country":51,"countryCode":52,"cosmosGeoPoint":180,"geoPoint":182,"contacts":183},"Unfallkrankenhaus Meidling","1120",{"type":54,"coordinates":181},[171,172],{"lat":172,"lon":171},[184],{"name":185,"role":38,"phone":26,"phoneExt":26,"email":26},"Christian Fialka, Prim.",{"facility":187,"status":151,"city":167,"state":26,"zip":188,"country":51,"countryCode":52,"cosmosGeoPoint":189,"geoPoint":191,"contacts":26},"Unfallkrankenhaus Lorenz Böhler","1200",{"type":54,"coordinates":190},[171,172],{"lat":172,"lon":171},{"facility":193,"status":194,"city":167,"state":26,"zip":195,"country":51,"countryCode":52,"cosmosGeoPoint":196,"geoPoint":198,"contacts":199},"SMZ Ost, Donauspital Abteilung für Unfallchirurgie","NOT_YET_RECRUITING","1220",{"type":54,"coordinates":197},[171,172],{"lat":172,"lon":171},[200],{"name":201,"role":38,"phone":26,"phoneExt":26,"email":26},"Medhi Mousavi, Prim",{"type":34,"investigatorFullName":203,"investigatorTitle":204,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Wolfgang Schaden","Deputy Medical Director of Austrian Workers´ Compensation Board (AUVA)","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",false,"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","ALL","18 Years","99 Years",{"count":216,"type":217},246,"ESTIMATED","INTERVENTIONAL",[220],"NA","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.",[223],"Acute Traumatic Spinal Cord Injury","2024-01-31",{"date":226,"type":227},"2024-02-01","ACTUAL",{"date":229,"type":227},"2020-07-02",{"date":231,"type":217},"2026-12-31",{"name":5,"class":6},15]