Clinical trial NCT01571531: European Multicentre Study of Human Spinal Cord Injury
Official title: European Multicentre Study of Human SCI
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Cord Injury
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2012-04-05
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

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.


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

Primary outcomes:
measure: Spinal Cord Independence Measure (SCIM)
timeFrame: Change in course from 2 weeks at 48 weeks
measure: International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI score)
timeFrame: Change in course from 2 weeks at 48 weeks
measure: Walking Index for Spinal Cord Injury (WISCI)
timeFrame: Change in course from 2 weeks at 48 weeks
measure: 10 Meter Walk Test (10mWT)
timeFrame: Change in course from 2 weeks at 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
affiliation: University of Zurich
name: Armin Curt, Prof., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Zurich
name: Martin Schubert, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.