Autoimmunity And Immune Deficiency After Spinal Cord Injury: Association With Rehabilitation Outcomes
- Conditions
- Spinal Cord Trauma
- Registration Number
- NCT04211636
- Lead Sponsor
- Marcel Kopp, MD
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 81
- 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).
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
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
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
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
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
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
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
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
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
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.
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 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
Sympathetic skin response 2 weeks, 3 months Skin response at palm and sole
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
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
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
Markers of Ferroptosis 1week, 3 months Immunoassays in plasma and CSF