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European Multicentre Study of Human Spinal Cord Injury

European Multicentre Study of Human SCI

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01571531
Enrollment
8000
Registered
2012-04-05
Start date
2004-04-30
Completion date
2026-08-31
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

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.

Interventions

None listed

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Walking Index for Spinal Cord Injury (WISCI)Change in course from 2 weeks at 48 weeksScore 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 weeksScore 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 weeksScore from 0 to 112; the higher the score, the better the neurological status of the patient

Countries

Switzerland

Contacts

Primary ContactArmin Curt, Prof., MD
armin.curt@balgrist.ch+41 44 386 39 01
Backup ContactMartin Schubert, MD
martin.schubert@balgrist.ch+41 44 386 39 45

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026