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Recruiting NCT01571531

European Multicentre Study of Human Spinal Cord Injury

Trial Parameters

Condition Spinal Cord Injury
Sponsor University of Zurich
Study Type OBSERVATIONAL
Phase N/A
Enrollment 8,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2004-04
Completion 2026-08

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.

Eligibility 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

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