European Multicentre Study of Human Spinal Cord Injury
ConditionSpinal Cord Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Zurich
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
primary care clinic
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Spinal Cord Independence Measure (SCIM)
Score from 0 to 100 points; the higher the score, the higher the independence of the patient
Time frame
Change in course from 2 weeks at 48 weeks2
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
Time frame
Change in course from 2 weeks at 48 weeks3
Walking Index for Spinal Cord Injury (WISCI)
Score from 0 to 20; the higher the score, the better the walking ability of the patient
Time frame
Change in course from 2 weeks at 48 weeks4
10 Meter Walk Test (10mWT)
Time frame
Change in course from 2 weeks at 48 weeksSponsors and contacts
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Source ClinicalTrials.gov