European Multicentre Study of Human Spinal Cord Injury

European Multicentre Study of Human SCI

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injury

• Study Type: Observational
• Enrollment (Estimated): 8000

Contacts and Locations

• Study Contact: Name: Armin Curt, Prof., MD; Phone Number: +41 44 386 39 01; Email: armin.curt@balgrist.ch
• Study Contact Backup: Name: Martin Schubert, MD; Phone Number: +41 44 386 39 45; Email: martin.schubert@balgrist.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8008
    • Recruiting
    • University of Zurich
    • Contact: Martin Schubert, MD; Email: Martin.Schubert@balgrist.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

primary care clinic

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
10 Meter Walk Test (10mWT)		Change in course from 2 weeks at 48 weeks

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Armin Curt, Prof., MD, University of Zurich; Study Director: Martin Schubert, MD, University of Zurich

Publications and helpful links

General Publications

• Pavese C, Scivoletto G, Puci MV, Abel R, Curt A, Maier D, Rupp R, Schubert M, Weidner N, Montomoli C, Kessler TM. Prediction of bowel management independence after ischemic spinal cord injury. Eur J Phys Rehabil Med. 2022 Oct;58(5):709-714. doi: 10.23736/S1973-9087.22.07366-X. Epub 2022 Jun 6.
• Franz S, Rust L, Heutehaus L, Rupp R, Schuld C, Weidner N. Impact of Heterotopic Ossification on Functional Recovery in Acute Spinal Cord Injury. Front Cell Neurosci. 2022 Feb 9;16:842090. doi: 10.3389/fncel.2022.842090. eCollection 2022.
• Sliwinski C, Heutehaus L, Taberner FJ, Weiss L, Kampanis V, Tolou-Dabbaghian B, Cheng X, Motsch M, Heppenstall PA, Kuner R, Franz S, Lechner SG, Weidner N, Puttagunta R. Contribution of mechanoreceptors to spinal cord injury-induced mechanical allodynia. Pain. 2024 Jun 1;165(6):1336-1347. doi: 10.1097/j.pain.0000000000003139. Epub 2023 Dec 27.
• Buri M, Curt A, Steeves J, Hothorn T. Baseline-adjusted proportional odds models for the quantification of treatment effects in trials with ordinal sum score outcomes. BMC Med Res Methodol. 2020 May 6;20(1):104. doi: 10.1186/s12874-020-00984-2.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2004
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 2, 2012
• First Submitted That Met QC Criteria: April 4, 2012
• First Posted (Estimated): April 5, 2012

Study Record Updates

• Last Update Posted (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: EK-03/2004 / PB_2016-00293

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No