Spinal Cord InjuryNCT01571531
European Multicentre Study of Human Spinal Cord Injury
An observational study of Spinal Cord Injury, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- How many people
- 8,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2004to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University of Zurich
Zurich, 8008
Martin Schubert, MD, Martin.Schubert@balgrist.ch
About this study
Official title: European Multicentre Study of Human SCI
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.
- Conditions
- Spinal Cord Injury
- Medical subject headings
- Spinal Cord Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal Cord Independence Measure (SCIM)
Score from 0 to 100 points; the higher the score, the higher the independence of the patient
Measured: Change in course from 2 weeks at 48 weeks
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
Measured: Change in course from 2 weeks at 48 weeks
Walking Index for Spinal Cord Injury (WISCI)
Score from 0 to 20; the higher the score, the better the walking ability of the patient
Measured: Change in course from 2 weeks at 48 weeks
10 Meter Walk Test (10mWT)
Measured: Change in course from 2 weeks at 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startApr 2004
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armin Curt, Prof., MD, Principal investigator, University of ZurichMartin Schubert, MD, Study director, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571531
- Sponsor's protocol ID
- EK-03/2004 / PB_2016-00293
- Status last verified
- Sep 2026
- First submitted
- 2 Apr 2012
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 41428979Sliwinski 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.
PubMed 38739766Jende 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.
PubMed 38235932Pavese 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.
PubMed 35666490Franz 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.
PubMed 35221928Buri 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.
PubMed 32375705
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Multicentre Study of Human SCI
- ClinicalTrials.gov ID
- NCT01571531
- Acronym / sponsor ID
- EK-03/2004 / PB_2016-00293
- Conditions
- Spinal Cord Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Apr 2004 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Spinal Cord Independence Measure (SCIM)
Time frame: Change in course from 2 weeks at 48 weeks
Score from 0 to 100 points; the higher the score, the higher the independence of the patient
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI score)
Time frame: Change in course from 2 weeks at 48 weeks
Score from 0 to 112; the higher the score, the better the neurological status of the patient
Walking Index for Spinal Cord Injury (WISCI)
Time frame: Change in course from 2 weeks at 48 weeks
Score from 0 to 20; the higher the score, the better the walking ability of the patient
10 Meter Walk Test (10mWT)
Time frame: Change in course from 2 weeks at 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Derived from this study: PubMed 41428979Pavese 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.
- Derived from this study: PubMed 38739766Sliwinski 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.
- Derived from this study: PubMed 38235932Jende 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.
- Derived from this study: PubMed 35666490Pavese 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.
- Derived from this study: PubMed 35221928Franz 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.
- Derived from this study: PubMed 32375705Buri 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Armin Curt, Prof., MD principal investigator
University of Zurich
Martin Schubert, MD study director
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Armin Curt, Prof., MD (+41 44 386 39 01, armin.curt@balgrist.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal Cord Independence Measure (SCIM) (time frame: Change in course from 2 weeks at 48 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01571531, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.