Spinal Cord Trauma
Conditions
Brief summary
The SCIentinel-prolong study systematically analyzes humoral autoantibody responses and thier interaction with post-spinal cord injury (SCI) immune-deficiency and infections as well as their association with the clinical course of rehabilitation. Therefore, molecular and immunological tests in blood and cerebrospinal fluid specimen are combined with clinical outcomes ranging from neurological function, neuropathic pain and spasticity to walking tests and measures of independence in daily living within the first year after SCI. Including a control group with participants suffering from vertebral fractures without SCI allows to differentiate between neurological and general injury and treatment effects.
Interventions
None listed
Sponsors
Foundation Wings For Life
University Hospital Tuebingen
Unfallkrankenhaus Berlin
Balgrist University Hospital
I.R.C.C.S. Fondazione Santa Lucia
University of Zurich
Medical University of Vienna
Ruhr University of Bochum
Swiss Federal Institute of Technology
King's College London
McGill University Health Centre/Research Institute of the McGill University Health Centre
Ohio State University
Marcel Kopp, MD
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Inclusion criteria
* Acute traumatic SCI, American Spinal Injury Association Impairment Scale (AIS) A to D, neurologic level of injury C3 - L2 or acute vertebral fracture without SCI * Inclusion within 21 days post-injury * For Italian centers only: SCI-Treatment using Methylprednisolone (according to NASCIS).
Exclusion criteria
* Non-traumatic SCI * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-traumatic autoimmunity | 3 months (10-14 weeks) post injury | Prevalence of autoantibodies against central and peripheral nervous system antigens in cerebrospinal fluid and serum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Standards for Neurological Classification of SCI - Lower Extremity Motor Score | 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury | Minimum 0, maximum 50; higher scores mean a better outcome |
| International Standards for Neurological Classification of SCI - Sensory light touch score | 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury | Minimum 0, maximum 112; higher scores mean a better outcome |
| International Standards for Neurological Classification of SCI - Sensory pin prick score | 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury | Minimum 0, maximum 112; higher scores mean a better outcome |
| American Spinal Injury Association Impairment Scale | 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury | Ordinal alphabetical scale. Range A to E. Change in the scale to one of the subsequent letters in the alphabet means a better outcome. |
| Spinal Cord Independence Measure III | 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury | Composite instrument for the assessment of physical independence; minimum 0, maximum 100; higher scores mean a better outcome |
| Walking Index for Spinal Cord Injury II | 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury | Score for walking ability; minimum 0, maximum 20; higher scores mean a better outcome |
| 10m-walk-test | 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury | Time in seconds required for 10 meter walking; higher scores mean a worse outcome |
| Timed-up-and go | 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury | Time in seconds needed to raise from a chair, walk a distance of 3 m, turn back and sit down again; higher scores mean a worse outcome |
| 6-minutes-walk-test | 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury | Walking distance in meters covered in 6 minutes; higher scores mean a better outcome |
| Neuropathic Pain Scale 10 | 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury | Instrument comprising 10 numeric analogue scales for intensity and qualities of pain; each item ranges from 0-10; higher scores mean a worse outcome |
| Spinal Cord Injury Pain Basic Dataset | 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury | Composite instrument for the assessment of pain locations, type and intensity |
| International Standards for Neurological Classification of SCI - Upper Extremity Motor Score | 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury | Minimum 0, maximum 50; higher scores mean a better outcome |
| Penn spasm frequency scale | 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury | Patient rated frequency of spasms; minimum 0, maximum 4; higher scores mean a worse outcome |
| Somatosensory evoked potentials | 2 weeks, 3 months | Tibial nerve and ulnar nerve; response is graded as ranging from 1=abolished to 4=normal response; higher scores mean better outcome |
| Motor evoked potentials | 2 weeks, 3 months | Anterior tibial muscle, abductor hallucis, abductor digiti minimi; response is graded as ranging from 1=abolished to 4=normal response; higher scores mean better outcome |
| Electroneurography | 2 weeks, 3 months | Abductor hallucis and abductor digiti minimi; latency, amplitude and F-waves |
| Sympathetic skin response | 2 weeks, 3 months | Skin response at palm and sole |
| Human Leukocyte Antigen - DR isotype expression on monocytes | 1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury | Anti-Human Leukocyte Antigen - DR isotype antibodies bound per monocyte, higher values mean better outcome |
| Immune phenotyping | 1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury | Panel of T-lymphocyte and B-lymphocyte subpopulations |
| Functional immune assays | 1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury | White blood cell ex-vivo stimulation |
| Damage Associated Molecular Patterns | 1week, 3 months, | Immunoassays in plasma and CSF |
| Markers of Ferroptosis | 1week, 3 months | Immunoassays in plasma and CSF |
| Modified Ashworth Scale | 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury | Assessment of muscle tone and resistance to passive motion; minimum 0, maximum 4, higher scores mean a worse outcome |
Contacts
Primary ContactMarcel A Kopp, MD
Backup ContactChristian Blex, PhD
Outcome results
None listed