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Autoimmunity And Immune Deficiency After Spinal Cord Injury: Association With Rehabilitation Outcomes

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ClinicalTrials.gov Identifier: NCT04211636
Recruitment Status : Not yet recruiting
First Posted : December 26, 2019
Last Update Posted : March 15, 2021
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Marcel Kopp, MD, Charite University, Berlin, Germany

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.

Condition or disease
Spinal Cord Trauma

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Study Type : Observational
Estimated Enrollment : 81 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Complete SCI, AIS A
Patients with complete spinal cord injury (AIS A)
Incomplete SCI, AIS B, C, D
Patients with incomplete spinal cord injury (AIS B, C, D)
Vertebral injuries without SCI
Patients with vertebral injuries without spinal cord injury (control)



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. International Standards for Neurological Classification of SCI - Upper Extremity Motor Score [ Time Frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury ]
    Minimum 0, maximum 50; higher scores mean a better outcome

  2. International Standards for Neurological Classification of SCI - Lower Extremity Motor Score [ Time Frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury ]
    Minimum 0, maximum 50; higher scores mean a better outcome

  3. International Standards for Neurological Classification of SCI - Sensory light touch score [ Time Frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury ]
    Minimum 0, maximum 112; higher scores mean a better outcome

  4. International Standards for Neurological Classification of SCI - Sensory pin prick score [ Time Frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury ]
    Minimum 0, maximum 112; higher scores mean a better outcome

  5. American Spinal Injury Association Impairment Scale [ Time Frame: 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. Spinal Cord Independence Measure III [ Time Frame: 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

  7. Walking Index for Spinal Cord Injury II [ Time Frame: 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

  8. 10m-walk-test [ Time Frame: 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

  9. Timed-up-and go [ Time Frame: 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

  10. 6-minutes-walk-test [ Time Frame: 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

  11. Neuropathic Pain Scale 10 [ Time Frame: 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

  12. Spinal Cord Injury Pain Basic Dataset [ Time Frame: 2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury ]
    Composite instrument for the assessment of pain locations, type and intensity

  13. Modified Ashworth Scale [ Time Frame: 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

  14. Penn spasm frequency scale [ Time Frame: 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

  15. Somatosensory evoked potentials [ Time Frame: 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

  16. Motor evoked potentials [ Time Frame: 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

  17. Electroneurography [ Time Frame: 2 weeks, 3 months ]
    Abductor hallucis and abductor digiti minimi; latency, amplitude and F-waves

  18. Sympathetic skin response [ Time Frame: 2 weeks, 3 months ]
    Skin response at palm and sole

  19. Human Leukocyte Antigen - DR isotype expression on monocytes [ Time Frame: 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

  20. Immune phenotyping [ Time Frame: 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

  21. Functional immune assays [ Time Frame: 1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury ]
    White blood cell ex-vivo stimulation

  22. Damage Associated Molecular Patterns [ Time Frame: 1week, 3 months, ]
    Immunoassays in plasma and CSF

  23. Markers of Ferroptosis [ Time Frame: 1week, 3 months ]
    Immunoassays in plasma and CSF


Biospecimen Retention:   Samples With DNA
Serum, plasma, peripheral blood mononuclear cells, cerebrospinal fluid


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Participants from primary care clinics
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04211636


Contacts
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Contact: Marcel A Kopp, MD +49 30 450560075 marcel.kopp@charite.de
Contact: Christian Blex, PhD +49 30 450560075 christian.blex@charite.de

Locations
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Germany
BG Hospital Unfallkrankenhaus Berlin, Treatment Centre for Spinal Cord Injuries
Berlin, Germany
Contact: Thomas Liebscher, MD         
Italy
Center for Neurorehabilitation, Santa Lucia Foundation
Rome, Italy
Contact: Marcella Masciullo, PhD         
Sponsors and Collaborators
Marcel Kopp, MD
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
Investigators
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Study Chair: Jan M Schwab, MD, PhD Ohio State University
Study Director: Marcel A Kopp, MD Charite University, Berlin, Germany
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Responsible Party: Marcel Kopp, MD, Study Coordinator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04211636    
Other Study ID Numbers: SCIentinel-prolong
First Posted: December 26, 2019    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries