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

NCT04211636 | Not Yet Recruiting

• 1 other identifier: SCIentinel-prolong
• Study Type: observational
• Target: 81
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Trauma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• 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

Study Arms (3)

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)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants from primary care clinics

You may qualify if:

• 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
• For Italian centers only: SCI-Treatment using Methylprednisolone (according to NASCIS).

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, peripheral blood mononuclear cells, cerebrospinal fluid

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jan M Schwab, MD, PhD

  Ohio State University

  STUDY CHAIR

• Marcel A Kopp, MD

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Central Study Contacts

Marcel A Kopp, MD

CONTACT

+49 30 450560075; marcel.kopp@charite.de

Christian Blex, PhD

CONTACT

+49 30 450560075; christian.blex@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Coordinator

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 26, 2019
• Study Start: October 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: April 1, 2026
• Last Updated: February 8, 2023

Record last verified: 2023-02