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European Multicentre Study of Human Spinal Cord Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01571531
First received: April 2, 2012
Last updated: October 28, 2014
Last verified: October 2014
  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: 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 und ASIA scores [ Time Frame: 2weeks, 1month, 3months, 6months, 12months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2300
Study Start Date: April 2004
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01571531     History of Changes
Other Study ID Numbers: EMSCI
Study First Received: April 2, 2012
Last Updated: October 28, 2014
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on November 24, 2014