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
Sponsor study identifier
observational
81
0 countries
N/A
Study Start
October 2023
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Primary Completion
October 2025
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Study Completion
April 2026
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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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2026
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 20, 2019
Actual (reported)December 26, 2019
Actual (reported)October 2023
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October 2025
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April 2026
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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
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 - Lower Extremity Motor Score
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
International Standards for Neurological Classification of SCI - Sensory pin prick 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
Patients with complete spinal cord injury (AIS A)
Patients with incomplete spinal cord injury (AIS B, C, D)
Patients with vertebral injuries without spinal cord injury (control)
Participants from primary care clinics
Serum, plasma, peripheral blood mononuclear cells, cerebrospinal fluid
Jan M Schwab, MD, PhD
Ohio State University
Marcel A Kopp, MD
Charite University, Berlin, Germany
First Submitted
December 20, 2019
First Posted
December 26, 2019
Study Start
October 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 2025
Brain-Controlled Spinal Stimulation Walking Therapy After Incomplete Spinal Cord Injury (SCI)
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 8, 2023
Record last verified: 2023-02
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