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European Multicentre Study of Human Spinal Cord Injury

This study is currently recruiting participants.
Verified November 2017 by University of Zurich
Sponsor:
ClinicalTrials.gov Identifier:
NCT01571531
First Posted: April 5, 2012
Last Update Posted: November 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
  Purpose
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
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: European Multicentre Study of Human SCI

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • SCIM, ASIA scores and walk tests (WISCI, 10mWT) [ Time Frame: 2weeks, 1month, 3months, 6months, 12months ]

Estimated Enrollment: 5500
Study Start Date: April 2004
Estimated Study Completion Date: August 2026
Estimated Primary Completion Date: August 2026 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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
Switzerland
University of Zurich Recruiting
Zurich, Switzerland, 8008
Contact: Martin Schubert, MD       Martin.Schubert@balgrist.ch   
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Armin Curt, Prof., MD University of Zurich
Study Director: Martin Schubert, MD University of Zurich
  More Information

Additional Information:
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01571531     History of Changes
Other Study ID Numbers: EK-03/2004 / PB_2016-00293
First Submitted: April 2, 2012
First Posted: April 5, 2012
Last Update Posted: November 2, 2017
Last Verified: November 2017

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