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.
Study Type
OBSERVATIONAL
Enrollment
81
Post-traumatic autoimmunity
Prevalence of autoantibodies against central and peripheral nervous system antigens in cerebrospinal fluid and serum
Time frame: 3 months (10-14 weeks) post injury
International Standards for Neurological Classification of SCI - Upper Extremity Motor Score
Minimum 0, maximum 50; higher scores mean a better outcome
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
International Standards for Neurological Classification of SCI - Lower Extremity Motor Score
Minimum 0, maximum 50; higher scores mean a better outcome
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
International Standards for Neurological Classification of SCI - Sensory light touch score
Minimum 0, maximum 112; higher scores mean a better outcome
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
International Standards for Neurological Classification of SCI - Sensory pin prick score
Minimum 0, maximum 112; higher scores mean a better outcome
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
American Spinal Injury Association Impairment Scale
Ordinal alphabetical scale. Range A to E. Change in the scale to one of the subsequent letters in the alphabet means a better outcome.
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Spinal Cord Independence Measure III
Composite instrument for the assessment of physical independence; minimum 0, maximum 100; higher scores mean a better outcome
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Walking Index for Spinal Cord Injury II
Score for walking ability; minimum 0, maximum 20; higher scores mean a better outcome
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
10m-walk-test
Time in seconds required for 10 meter walking; higher scores mean a worse outcome
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Timed-up-and go
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
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
6-minutes-walk-test
Walking distance in meters covered in 6 minutes; higher scores mean a better outcome
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Neuropathic Pain Scale 10
Instrument comprising 10 numeric analogue scales for intensity and qualities of pain; each item ranges from 0-10; higher scores mean a worse outcome
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Spinal Cord Injury Pain Basic Dataset
Composite instrument for the assessment of pain locations, type and intensity
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Modified Ashworth Scale
Assessment of muscle tone and resistance to passive motion; minimum 0, maximum 4, higher scores mean a worse outcome
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Penn spasm frequency scale
Patient rated frequency of spasms; minimum 0, maximum 4; higher scores mean a worse outcome
Time frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Somatosensory evoked potentials
Tibial nerve and ulnar nerve; response is graded as ranging from 1=abolished to 4=normal response; higher scores mean better outcome
Time frame: 2 weeks, 3 months
Motor evoked potentials
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
Time frame: 2 weeks, 3 months
Electroneurography
Abductor hallucis and abductor digiti minimi; latency, amplitude and F-waves
Time frame: 2 weeks, 3 months
Sympathetic skin response
Skin response at palm and sole
Time frame: 2 weeks, 3 months
Human Leukocyte Antigen - DR isotype expression on monocytes
Anti-Human Leukocyte Antigen - DR isotype antibodies bound per monocyte, higher values mean better outcome
Time frame: 1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury
Immune phenotyping
Panel of T-lymphocyte and B-lymphocyte subpopulations
Time frame: 1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury
Functional immune assays
White blood cell ex-vivo stimulation
Time frame: 1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury
Damage Associated Molecular Patterns
Immunoassays in plasma and CSF
Time frame: 1week, 3 months,
Markers of Ferroptosis
Immunoassays in plasma and CSF
Time frame: 1week, 3 months
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