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The Austrian Spinal Cord Injury Study (ASCIS)

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ClinicalTrials.gov Identifier: NCT03109782
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Thomas Freude, Prof. M.D., Paracelsus Medical University

Brief Summary:
Traumatic spinal cord injury (tSCI) is a debilitating disease that leads to neurological deficits and often has long-term effects including severe lifelong disability. Given the devastating personal and economic consequences of SCI, it is critical to collect high-quality, prospective data. SCI has not been systemically assessed in Austria, and data regarding the etiology, incidence and prevalence are missing or significantly limited. More importantly to the individuals suffering from SCI, health care for SCI patients in Austria is not concentrated in specialized SCI centers but fragmented, which might result in a less effective recovery and rehabilitation of patients. Accordingly, the Paracelsus Medical University Salzburg (PMU) and the Austrian Social Insurance for Occupational Risks (AUVA) initiated the Austrian Spinal Cord Injury Study (ASCIS) at the beginning of 2012. ASCIS is defined as an organized network that uses observational methods to collect uniform longitudinal clinical data that can provide insight into current patient care parameters and evaluates the outcome of SCI patients. ASCIS was initiated with the aim to develop a registry for patients with tSCI in Austria as a base for addressing research questions, improving patient outcomes and establishing a platform for future clinical trials. Furthermore, a major goal of ASCIS is to get knowledge about the natural recovery after spinal cord lesion in a larger population of patients in the sense of a historical control group and bring new standardized assessment tools to the clinical setting. Due to the involvement of acute trauma hospitals and rehabilitation centers, ASCIS is uniquely positioned to capture detailed hospital-related information on the (very)-acute, rehabilitation and chronic phases of tSCI patients. Additionally, ASCIS is cooperation partner of the European Multi-Center Study about Spinal Cord Injury (EMSCI).

Condition or disease
Traumatic Spinal Cord Injury

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: The Austrian Spinal Cord Injury Study (ASCIS)
Actual Study Start Date : December 2012
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Change in American Spinal Injury Association Impairment Scale (AIS) [ Time Frame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury ]

Secondary Outcome Measures :
  1. Change in American Spinal Injury Association Motor Score (ASIAMS) [ Time Frame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury ]
  2. Change in American Spinal Injury Association Sensory Score (ASIASS) [ Time Frame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury ]
  3. Change in Spinal Cord Independency Measure (SCIM) [ Time Frame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury ]
  4. Change in Walking Index for Spinal Cord Injury (WISCI II) [ Time Frame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury ]
  5. Change in Timed Up and Go Test (TuG) [ Time Frame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury ]
  6. Change in 6 Minute Walking Test (6MWT) [ Time Frame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury ]
  7. Change in 10 Meter Timed Walk (10MTW) [ Time Frame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury ]
  8. Change in quality of life using the Short Form 36 (SF-36) questionnaire [ Time Frame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury ]


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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary Care Centers
Criteria

Inclusion Criteria:

  • Patients suffering from paresis or plegia after trauma
  • First ASCIS assessment possible within the first 3 days after incidence
  • Patient capable and willing of giving written informed consent
  • No cognitive impairment which would preclude an informed consent (including severe traumatic brain injury)

Exclusion Criteria:

  • Nontraumatic paresis or plegia (e.g. disc-herniation, tumor, AV-malformation, myelitis)
  • Previously known dementia or severe reduction of intelligence, leading to reduced capabilities of cooperation or giving consent
  • Peripheral nerve lesion above the level of lesion (e.g. Plexus brachialis impairment)
  • Previously known polyneuropathy
  • Severe craniocerebral injury

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109782


Contacts
Contact: Herbert Resch, Prof. M.D. +43 662 2420-80101 herbert.resch@pmu.ac.at
Contact: Wolfgang Schaden, M.D. +43 5 93 93-20170 wolfgang.schaden@auva.at

Locations
Austria
Hospital Amstetten, Department of Traumatology Recruiting
Amstetten, Austria
Contact: Andreas Pachucki, M.D       Andreas.pachucki@amstetten.lknoe.at   
Ordensklinikum Barmherzige Brüder Eisenstadt, Department of Orthopaedic Surgery Recruiting
Eisenstadt, Austria
Contact: Harald Boszotta, Prof. M.D.       Harald.boszotta@bbeisen.at   
Contact: David Böckmann       David.Boeckmann@bbeisen.at   
Academic Hospital Feldkirch, Department for Trauma Surgery and Sports Traumatology Recruiting
Feldkirch, Austria
Contact: Alexander Gohm, M.D.       alexander.gohm@lkhf.at   
Contact: Michael Osti, Doz. M.D.       michael.osti@lkhf.at   
Trauma Center Graz Recruiting
Graz, Austria
Contact: Michael Plecko, M.D.       Michael.plecko@auva.at;   
Contact: Günter Kohrgruber, M.D.       guenter.kohrgruber@auva.at   
University Clinic Graz, Department of Orthopaedics and Traumatology, Medical University Graz Recruiting
Graz, Austria
Contact: Fraz Josef Seibert, Prof. M.D.       Franz-Josef.Seibert@klinikum-graz.at   
Contact: Ellen Tackner, M.D.       Ellen.tackner@medunigraz.at   
Hospital Horn, Department of Traumatology Recruiting
Horn, Austria
Contact: Thomas Neubauer, M.D.       Thomas.Neubauer@horn.lknoe.at   
Hospital Klagenfurt, Department of Trauma Surgery and Sports Traumatology Recruiting
Klagenfurt, Austria
Contact: Ernst Müller, Prof. M.D.       ernst.mueller@kabeg.at   
Contact: Arnold Gstrein, M.D.       arnold.gstrein@kabeg.at   
Trauma Center Klagenfurt Recruiting
Klagenfurt, Austria
Contact: Vinzenz Smekal, Doz. M.D.       vinzenz.smekal@auva.at   
Trauma Center Linz, Teaching Hospital of the Paracelsus Medical University Linz Recruiting
Linz, Austria
Contact: Klaus Katzensteiner, M.D.       Klaus.Katzensteiner@auva.at   
Contact: Georg Mattiassich, M.D.       georg.mattiassich@auva.at   
University Clinic Linz, Department of Neurosurgery, Kepler University Linz Recruiting
Linz, Austria
Contact: Andreas Gruber, Prof. M.D.       andreas.gruber@gespag.at   
University Clinic Linz, Department of Orthopaedics and Traumatology, Kepler University Linz Recruiting
Linz, Austria
Contact: Oskar Kwasny, Prof. M.D.       oskar.kwasny@kepleruniklinikum.at   
Trauma Center Salzburg, Teaching Hospital of the Paracelsus Medical University Salzburg Recruiting
Salzburg, Austria
Contact: Josef Obrist, M.D.       josef.obrist@auva.at   
Contact: Markus Lill, M.D.       markus.lill@auva.at   
University Clinic Salzburg, Department of Orthopaedics and Traumatology, Paracelsus Medical University Recruiting
Salzburg, Austria
Contact: Thomas Freude, Prof. M.D.    00435 7255-50001    t.freude@salk.at   
University Clinic St. Pölten, Department of Orthopaedics and Traumatology Recruiting
St. Pölten, Austria
Contact: Hermann Schnell, M.D.       hermann.schnell@stpoelten.lknoe.at   
Contact: Alexander Wels, M.D.       Alexander.wels@stpoelten.lknoe.at   
Lorenz Böhler Trauma Center Vienna Recruiting
Vienna, Austria
Contact: Thomas Hausner, Prof. M.D.       thomas.hausner@auva.at   
SMZ Ost Donauspital, Department of Traumatology Recruiting
Vienna, Austria
Contact: Mehdi Mousavi, Prof. M.D.       mehdi.mousavi@meduniwien.ac.at   
University Clinic Vienna, Department of Trauma Surgery, Medical University of Vienna Recruiting
Vienna, Austria
Contact: Gholam Pajenda, Prof. M.D.       gholam.pajenda@meduniwien.ac.at   
Contact: Thomas Haider, M.D. PhD.       thomas.a.haider@meduniwien.ac.at   
Hospital Wiener Neustadt, Department of Traumaotlogy Recruiting
Wiener Neustadt, Austria
Contact: Franz Ortner, M.D.       franz.ortner@wienerneustadt.lknoe.at   
Sponsors and Collaborators
Paracelsus Medical University
Investigators
Study Chair: Herbert Resch, Prof. M.D. Paracelsus Medical University
Principal Investigator: Thomas Freude, Prof. M.D. University Clinic Salzburg, Department of Traumatology and Orthopaedics
Study Director: Wolfgang Schaden, M.D. Dir. Austrian Social Insurance for Occupational Risks (AUVA)

Additional Information:
Responsible Party: Thomas Freude, Prof. M.D., Principal Investigator, Head of Traumatology, Paracelsus Medical University
ClinicalTrials.gov Identifier: NCT03109782     History of Changes
Other Study ID Numbers: ascis1411
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thomas Freude, Prof. M.D., Paracelsus Medical University:
Spinal Cord Injury
Spine Surgery
Patient Registry
Trauma

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System