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NCT Number: NCT01571531

European Multicentre Study of Human Spinal Cord Injury

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Zurich

Zurich, 8008, Switzerland

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

European Multicentre Study of Human SCI

Important dates

Study start
2004
Primary completion
2026
Study completion
2026
First posted
Apr 5, 2012
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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