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European Multicentre Study of Human Spinal Cord Injury

NCT ID: NCT01571531

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

8000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-04-30

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injury

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Armin Curt, Prof., MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Martin Schubert, MD

Role: STUDY_DIRECTOR

University of Zurich

Locations

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University of Zurich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Armin Curt, Prof., MD

Role: CONTACT

Phone: +41 44 386 39 01

Email: [email protected]

Martin Schubert, MD

Role: CONTACT

Phone: +41 44 386 39 45

Email: [email protected]

Facility Contacts

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Martin Schubert, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 38739766 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35666490 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35221928 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32375705 (View on PubMed)

Related Links

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http://www.emsci.org

Related Info

Other Identifiers

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EK-03/2004 / PB_2016-00293

Identifier Type: -

Identifier Source: org_study_id