Observational study on spinal cord injury recovery in Europe
European Multicentre Study of Human SCI
This study is trying to understand how people recover from spinal cord injuries by collecting information from patients in Europe who have recently experienced these injuries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 8000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zurich) |
| Trial ID | NCT01571531 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather clinical, functional, and neurophysiological data from patients with spinal cord injuries (SCI) across several European paraplegic centers. By standardizing assessments, the study seeks to understand the natural recovery process following traumatic SCI and establish a clinical basis for future interventional therapies. The research will involve patients who have experienced a single event of traumatic or ischemic para- or tetraplegia, with assessments starting within six weeks of the incident. The goal is to monitor and evaluate significant effects of potential new treatments for SCI.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have experienced a single traumatic or ischemic spinal cord injury and can provide informed consent.
Not a fit: Patients with non-traumatic causes of paralysis or those with severe cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the recovery process after spinal cord injuries, paving the way for innovative therapies.
How similar studies have performed: Other studies have shown promise in understanding recovery from spinal cord injuries, but this approach aims to standardize assessments across multiple centers, which is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zurich
- University of Zurich — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Armin Curt, Prof., MD — University of Zurich
- Study coordinator: Armin Curt, Prof., MD
- Email: armin.curt@balgrist.ch
- Phone: +41 44 386 39 01
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.