NCT04211636Not yet recruitingNot Applicable
Maladaptive Systemic Immune Response After Spinal Cord Injury: Humoral Post-traumatic Autoimmunity Against Central and Peripheral Nervous System Antigens in Association With Neurogenous Immune Depression as a Confounder of Rehabilitation
Marcel Kopp, MD0 sites81 target enrollmentStarted: October 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 81
- Primary Endpoint
- Post-traumatic autoimmunity
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
Post-traumatic autoimmunity
Time Frame: 3 months (10-14 weeks) post injury
Prevalence of autoantibodies against central and peripheral nervous system antigens in cerebrospinal fluid and serum
Secondary Outcomes
- International Standards for Neurological Classification of SCI - Lower Extremity Motor Score(2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury)
- Modified Ashworth Scale(2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury)
- Somatosensory evoked potentials(2 weeks, 3 months)
- Motor evoked potentials(2 weeks, 3 months)
- Electroneurography(2 weeks, 3 months)
- 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)
- International Standards for Neurological Classification of SCI - Upper Extremity Motor Score(2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury)
- International Standards for Neurological Classification of SCI - Sensory pin prick score(2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury)
- Walking Index for Spinal Cord Injury II(2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury)
- 10m-walk-test(2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury)
- Timed-up-and go(2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury)
- Penn spasm frequency scale(2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury)
- International Standards for Neurological Classification of SCI - Sensory light touch score(2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury)
- American Spinal Injury Association Impairment Scale(2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury)
- 6-minutes-walk-test(2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury)
- Neuropathic Pain Scale 10(2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury)
- Spinal Cord Independence Measure III(2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury)
- Sympathetic skin response(2 weeks, 3 months)
- Functional immune assays(1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury)
- Damage Associated Molecular Patterns(1week, 3 months,)
- Spinal Cord Injury Pain Basic Dataset(2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury)
- Immune phenotyping(1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury)
- Markers of Ferroptosis(1week, 3 months)
Investigators
Marcel Kopp, MD
Study Coordinator
Charite University, Berlin, Germany
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