European Multicentre Study of Human Spinal Cord Injury

Recruiting

• Conditions: Spinal Cord Injury

• Registration Number: NCT01571531
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2012-04-02
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Walking Index for Spinal Cord Injury (WISCI)	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
10 Meter Walk Test (10mWT)	Change in course from 2 weeks at 48 weeks
Spinal Cord Independence Measure (SCIM)	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
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI score)	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

Trial Locations

Locations (1)

University of Zurich; 🇨🇭 Zurich, Switzerland