The Austrian Spinal Cord Injury Study

Traumatic Spinal Cord Injury Clinical Trial

— ASCIS  

Official title:

The Austrian Spinal Cord Injury Study (ASCIS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03109782
• Other study ID #: ascis1411
• Status: Recruiting
• Start date: December 2012
• Est. completion date: December 2023

Study information

• Verified date: August 2018
• Source: Paracelsus Medical University
• Contact: Herbert Resch, Prof. M.D.
• Phone: +43 662 2420-80101
• Email: herbert.resch[@]pmu.ac.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Traumatic Spinal Cord Injury
• Wounds and Injuries

Locations

Country	Name	City	State
Austria	Hospital Amstetten, Department of Traumatology	Amstetten
Austria	Ordensklinikum Barmherzige Brüder Eisenstadt, Department of Orthopaedic Surgery	Eisenstadt
Austria	Academic Hospital Feldkirch, Department for Trauma Surgery and Sports Traumatology	Feldkirch
Austria	Trauma Center Graz	Graz
Austria	University Clinic Graz, Department of Orthopaedics and Traumatology, Medical University Graz	Graz
Austria	Hospital Horn, Department of Traumatology	Horn
Austria	Hospital Klagenfurt, Department of Trauma Surgery and Sports Traumatology	Klagenfurt
Austria	Trauma Center Klagenfurt	Klagenfurt
Austria	Trauma Center Linz, Teaching Hospital of the Paracelsus Medical University Linz	Linz
Austria	University Clinic Linz, Department of Neurosurgery, Kepler University Linz	Linz
Austria	University Clinic Linz, Department of Orthopaedics and Traumatology, Kepler University Linz	Linz
Austria	Trauma Center Salzburg, Teaching Hospital of the Paracelsus Medical University Salzburg	Salzburg
Austria	University Clinic Salzburg, Department of Orthopaedics and Traumatology, Paracelsus Medical University	Salzburg
Austria	University Clinic St. Pölten, Department of Orthopaedics and Traumatology	St. Pölten
Austria	Lorenz Böhler Trauma Center Vienna	Vienna
Austria	SMZ Ost Donauspital, Department of Traumatology	Vienna
Austria	University Clinic Vienna, Department of Trauma Surgery, Medical University of Vienna	Vienna
Austria	Hospital Wiener Neustadt, Department of Traumaotlogy	Wiener Neustadt

Sponsors (1)

Lead Sponsor	Collaborator
Paracelsus Medical University

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in American Spinal Injury Association Impairment Scale (AIS)		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	Change in American Spinal Injury Association Motor Score (ASIAMS)		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	Change in American Spinal Injury Association Sensory Score (ASIASS)		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	Change in Spinal Cord Independency Measure (SCIM)		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	Change in Walking Index for Spinal Cord Injury (WISCI II)		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	Change in Timed Up and Go Test (TuG)		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	Change in 6 Minute Walking Test (6MWT)		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	Change in 10 Meter Timed Walk (10MTW)		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	Change in quality of life using the Short Form 36 (SF-36) questionnaire		Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury

External Links

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