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

Spinal Cord Trauma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04211636
• Other study ID #: SCIentinel-prolong
• Status: Not yet recruiting
• Start date: October 2023
• Est. completion date: April 2026

Study information

• Verified date: February 2023
• Source: Charite University, Berlin, Germany
• Contact: Marcel A Kopp, MD
• Phone: +49 30 450560075
• Email: marcel.kopp[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 81
• Est. completion date: April 2026
• Est. primary completion date: October 2025
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Trauma

Locations

Country	Name	City	State
n/a

Sponsors (13)

Lead Sponsor

Collaborator

Marcel Kopp, MD

Balgrist University Hospital, Foundation Wings For Life, I.R.C.C.S. Fondazione Santa Lucia, King's College London, McGill University Health Centre/Research Institute of the McGill University Health Centre, Medical University of Vienna, Ohio State University, Ruhr University of Bochum, Swiss Federal Institute of Technology, Unfallkrankenhaus Berlin, University Hospital Tuebingen, University of Zurich

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-traumatic autoimmunity	Prevalence of autoantibodies against central and peripheral nervous system antigens in cerebrospinal fluid and serum	3 months (10-14 weeks) post injury
Secondary	International Standards for Neurological Classification of SCI - Upper Extremity Motor Score	Minimum 0, maximum 50; higher scores mean a better outcome	2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Secondary	International Standards for Neurological Classification of SCI - Lower Extremity Motor Score	Minimum 0, maximum 50; higher scores mean a better outcome	2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Secondary	International Standards for Neurological Classification of SCI - Sensory light touch score	Minimum 0, maximum 112; higher scores mean a better outcome	2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Secondary	International Standards for Neurological Classification of SCI - Sensory pin prick score	Minimum 0, maximum 112; higher scores mean a better outcome	2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Secondary	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.	2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Secondary	Spinal Cord Independence Measure III	Composite instrument for the assessment of physical independence; minimum 0, maximum 100; higher scores mean a better outcome	2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Secondary	Walking Index for Spinal Cord Injury II	Score for walking ability; minimum 0, maximum 20; higher scores mean a better outcome	2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Secondary	10m-walk-test	Time in seconds required for 10 meter walking; higher scores mean a worse outcome	2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Secondary	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	2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Secondary	6-minutes-walk-test	Walking distance in meters covered in 6 minutes; higher scores mean a better outcome	2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Secondary	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	2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Secondary	Spinal Cord Injury Pain Basic Dataset	Composite instrument for the assessment of pain locations, type and intensity	2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Secondary	Modified Ashworth Scale	Assessment of muscle tone and resistance to passive motion; minimum 0, maximum 4, higher scores mean a worse outcome	2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Secondary	Penn spasm frequency scale	Patient rated frequency of spasms; minimum 0, maximum 4; higher scores mean a worse outcome	2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
Secondary	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	2 weeks, 3 months
Secondary	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	2 weeks, 3 months
Secondary	Electroneurography	Abductor hallucis and abductor digiti minimi; latency, amplitude and F-waves	2 weeks, 3 months
Secondary	Sympathetic skin response	Skin response at palm and sole	2 weeks, 3 months
Secondary	Human Leukocyte Antigen - DR isotype expression on monocytes	Anti-Human Leukocyte Antigen - DR isotype antibodies bound per monocyte, higher values mean better outcome	1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury
Secondary	Immune phenotyping	Panel of T-lymphocyte and B-lymphocyte subpopulations	1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury
Secondary	Functional immune assays	White blood cell ex-vivo stimulation	1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury
Secondary	Damage Associated Molecular Patterns	Immunoassays in plasma and CSF	1week, 3 months,
Secondary	Markers of Ferroptosis	Immunoassays in plasma and CSF	1week, 3 months