European Multicentre Study of Human Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

European Multicentre Study of Human SCI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01571531
• Other study ID #: EK-03/2004 / PB_2016-00293
• Status: Recruiting
• Start date: April 2004
• Est. completion date: August 2026

Study information

• Verified date: August 2023
• Source: University of Zurich
• Contact: Armin Curt, Prof., MD
• Phone: +41 44 386 39 01
• Email: armin.curt[@]balgrist.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Locations

Country	Name	City	State
Switzerland	University of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spinal Cord Independence Measure (SCIM)	Score from 0 to 100 points; the higher the score, the higher the independence of the patient	Change in course from 2 weeks at 48 weeks
Primary	International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI score)	Score from 0 to 112; the higher the score, the better the neurological status of the patient	Change in course from 2 weeks at 48 weeks
Primary	Walking Index for Spinal Cord Injury (WISCI)	Score from 0 to 20; the higher the score, the better the walking ability of the patient	Change in course from 2 weeks at 48 weeks
Primary	10 Meter Walk Test (10mWT)		Change in course from 2 weeks at 48 weeks

External Links

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