Clinical trial NCT04211636: Autoimmunity And Immune Deficiency After Spinal Cord Injury: Association With Rehabilitation Outcomes
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Spinal Cord Trauma
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Foundation Wings For Life
name: University Hospital Tuebingen
name: Unfallkrankenhaus Berlin
name: Balgrist University Hospital
name: I.R.C.C.S. Fondazione Santa Lucia
name: University of Zurich
name: Medical University of Vienna
name: Ruhr University of Bochum
name: Swiss Federal Institute of Technology
name: King's College London
name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Ohio State University
First posted: 2019-12-26
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants from primary care clinics

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Post-traumatic autoimmunity
timeFrame: 3 months (10-14 weeks) post injury
Secondary outcomes:
measure: International Standards for Neurological Classification of SCI - Upper Extremity Motor Score
timeFrame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
measure: International Standards for Neurological Classification of SCI - Lower Extremity Motor Score
timeFrame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
measure: International Standards for Neurological Classification of SCI - Sensory light touch score
timeFrame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
measure: International Standards for Neurological Classification of SCI - Sensory pin prick score
timeFrame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
measure: American Spinal Injury Association Impairment Scale
timeFrame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
measure: Spinal Cord Independence Measure III
timeFrame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
measure: Walking Index for Spinal Cord Injury II
timeFrame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
measure: 10m-walk-test
timeFrame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
measure: Timed-up-and go
timeFrame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
measure: 6-minutes-walk-test
timeFrame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
measure: Neuropathic Pain Scale 10
timeFrame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
measure: Spinal Cord Injury Pain Basic Dataset
timeFrame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
measure: Modified Ashworth Scale
timeFrame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
measure: Penn spasm frequency scale
timeFrame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
measure: Somatosensory evoked potentials
timeFrame: 2 weeks, 3 months
measure: Motor evoked potentials
timeFrame: 2 weeks, 3 months
measure: Electroneurography
timeFrame: 2 weeks, 3 months
measure: Sympathetic skin response
timeFrame: 2 weeks, 3 months
measure: Human Leukocyte Antigen - DR isotype expression on monocytes
timeFrame: 1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury
measure: Immune phenotyping
timeFrame: 1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury
measure: Functional immune assays
timeFrame: 1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury
measure: Damage Associated Molecular Patterns
timeFrame: 1week, 3 months,
measure: Markers of Ferroptosis
timeFrame: 1week, 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University
name: Jan M Schwab, MD, PhD
role: STUDY_CHAIR
affiliation: Charite University, Berlin, Germany
name: Marcel A Kopp, MD
role: STUDY_DIRECTOR
References: