European Multicentre Study of Human Spinal Cord Injury

NCT01571531 | Recruiting DMC

• 1 other identifier: EK-03/2004 / PB_2016-00293
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University of Zurich

Zurich, 8008, Switzerland

RECRUITING

Related Publications (5)

• Pavese C, Scivoletto G, Puci M, Rupp R, Schubert M, Rohrich F, Waldmann J, Weidner N, Kalke YB, Abel R, Maier D, Kriz J, Chhabra HS, Rehahn K, Montomoli C, Curt A, Jutzeler CR. The Relationship Between Age and Recovery After Spinal Cord Injury: A Longitudinal Cohort Study. Neurology. 2026 Jan 27;106(2):e214516. doi: 10.1212/WNL.0000000000214516. Epub 2025 Dec 23.

  PMID: 41428979 DERIVED

• 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.

  PMID: 38739766 DERIVED

• 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.

  PMID: 35666490 DERIVED

• 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.

  PMID: 35221928 DERIVED

• 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.

  PMID: 32375705 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Armin Curt, Prof., MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

• Martin Schubert, MD

  University of Zurich

  STUDY DIRECTOR

Central Study Contacts

Armin Curt, Prof., MD

CONTACT

+41 44 386 39 01; armin.curt@balgrist.ch

Martin Schubert, MD

CONTACT

+41 44 386 39 45; martin.schubert@balgrist.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: April 5, 2012
• Study Start: April 1, 2004
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

CH (1)