European Multicentre Study of Human Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
European Multicentre Study of Human SCI
Overview
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.
Primary outcome measures
- Spinal Cord Independence Measure (SCIM) [Time frame: Change in course from 2 weeks at 48 weeks]
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI score) [Time frame: Change in course from 2 weeks at 48 weeks]
- Walking Index for Spinal Cord Injury (WISCI) [Time frame: Change in course from 2 weeks at 48 weeks]
- 10 Meter Walk Test (10mWT) [Time frame: Change in course from 2 weeks at 48 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Switzerland · 1 center
- University of Zurich — Zurich
Publications
- 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
- 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
- Jende JME, Heutehaus L, Preisner F, Verez Sola CM, Mooshage CM, Heiland S, Rupp R, Bendszus M, Weidner N, Kurz FT, Franz S. Magnetic resonance neurography in spinal cord injury: Imaging findings and clinical significance. Eur J Neurol. 2024 Apr;31(4):e16198. doi: 10.1111/ene.16198. Epub 2024 Jan 18. PMID 38235932
- 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
- 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
- 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
Identifiers
NCT: NCT01571531 · EK-03/2004 / PB_2016-00293