Autoimmunity And Immune Deficiency After Spinal Cord Injury: Association With Rehabilitation Outcomes
NCT ID: NCT04211636
Last Updated: 2023-02-08
Study Results
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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NOT_YET_RECRUITING
81 participants
OBSERVATIONAL
2023-10-31
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Complete SCI, AIS A
Patients with complete spinal cord injury (AIS A)
No interventions assigned to this group
Incomplete SCI, AIS B, C, D
Patients with incomplete spinal cord injury (AIS B, C, D)
No interventions assigned to this group
Vertebral injuries without SCI
Patients with vertebral injuries without spinal cord injury (control)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Inclusion within 21 days post-injury
* For Italian centers only: SCI-Treatment using Methylprednisolone (according to NASCIS).
Exclusion Criteria
* Severe multiple trauma
* Serious traumatic brain injury
* Pre-exiting neurological diseases
* Malignant Neoplasia, except in complete remission for 5 years
* Rheumatic diseases / collagenosis / vasculitis
* Other autoimmune diseases
* Pre-existing chronic infection
* Severe alcohol or drug addiction
* Pregnancy or lactation
* Simultaneous participation in interventional clinical trials
* For centers in Germany or Switzerland only: SCI-treatment using Methylprednisolone (according to NASCIS).
18 Years
75 Years
ALL
No
Sponsors
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Foundation Wings For Life
OTHER
University Hospital Tuebingen
OTHER
Unfallkrankenhaus Berlin
OTHER
Balgrist University Hospital
OTHER
I.R.C.C.S. Fondazione Santa Lucia
OTHER
University of Zurich
OTHER
Medical University of Vienna
OTHER
Ruhr University of Bochum
OTHER
Swiss Federal Institute of Technology
OTHER
King's College London
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Ohio State University
OTHER
Marcel Kopp, MD
OTHER
Responsible Party
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Marcel Kopp, MD
Study Coordinator
Principal Investigators
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Jan M Schwab, MD, PhD
Role: STUDY_CHAIR
Ohio State University
Marcel A Kopp, MD
Role: STUDY_DIRECTOR
Charite University, Berlin, Germany
Central Contacts
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Other Identifiers
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SCIentinel-prolong
Identifier Type: -
Identifier Source: org_study_id
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