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European Multicentre Study of Human Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT01571531
Recruitment Status : Recruiting
First Posted : April 5, 2012
Last Update Posted : August 16, 2022
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief Summary:
Today there is accumulating evidence from animal experiments that regeneration can be induced after a spinal cord injury (SCI). Consequently in the near future, new therapeutic approaches to induce some regeneration will be included in the treatment of patients with SCI. The aim of this proposal is to provide the required clinical basis for the implementation of novel interventional therapies. The establishment of combined clinical, functional and neurophysiological measures for a qualitative and quantitative assessment of spinal cord function in patients with SCI at different stages during rehabilitation represents a basic requirement to monitor any significant effect of a new treatment. Therefore, several European Paraplegic Centres involved in the rehabilitation of acute traumatic SCI patients build up a close collaboration for standardised assessment. The aim 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 to bring new standardised assessment tools to the clinical setting.

Condition or disease
Spinal Cord Injury

Study Design
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Study Type : Observational
Estimated Enrollment : 5500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: European Multicentre Study of Human SCI
Study Start Date : April 2004
Estimated Primary Completion Date : August 2026
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Spinal Cord Independence Measure (SCIM) [ Time Frame: Change in course from 2 weeks at 48 weeks ]
    Score from 0 to 100 points; the higher the score, the higher the independence of the patient

  2. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI score) [ Time Frame: Change in course from 2 weeks at 48 weeks ]
    Score from 0 to 112; the higher the score, the better the neurological status of the patient

  3. Walking Index for Spinal Cord Injury (WISCI) [ Time Frame: Change in course from 2 weeks at 48 weeks ]
    Score from 0 to 20; the higher the score, the better the walking ability of the patient

  4. 10 Meter Walk Test (10mWT) [ Time Frame: Change in course from 2 weeks at 48 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
primary care clinic
Criteria

Inclusion Criteria:

  • Single event traumatic or ischemic para- or tetraplegia
  • First EMSCI assessment possible within the first 6 weeks after incidence
  • Patient capable and willing of giving written informed consent

Exclusion Criteria:

  • Nontraumatic para- or tetraplegia (i.e. discusprolaps, tumor, AV-malformation, myelitis) excl. single event ischemic incidences
  • Pre-known dementia or severe reduction of intelligence, leading to reduced capabilities of cooperation or giving consent
  • Peripheral nerve lesions above the level of lesion (i.e. plexus brachialis impairment)
  • Pre-known polyneuropathy
  • Severe craniocerebral injury
Contacts and Locations
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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): NCT01571531


Contacts
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Contact: Armin Curt, Prof., MD +41 44 386 39 01 armin.curt@balgrist.ch
Contact: Martin Schubert, MD +41 44 386 39 45 martin.schubert@balgrist.ch

Locations
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Switzerland
University of Zurich Recruiting
Zurich, Switzerland, 8008
Contact: Martin Schubert, MD       Martin.Schubert@balgrist.ch   
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Armin Curt, Prof., MD University of Zurich
Study Director: Martin Schubert, MD University of Zurich
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01571531    
Other Study ID Numbers: EK-03/2004 / PB_2016-00293
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: August 16, 2022
Last Verified: August 2022
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System