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

NCT ID: NCT04211636

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-31

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Trauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Complete SCI, AIS A

Patients with complete spinal cord injury (AIS A)

No interventions assigned to this group

Incomplete SCI, AIS B, C, D

Patients with incomplete spinal cord injury (AIS B, C, D)

No interventions assigned to this group

Vertebral injuries without SCI

Patients with vertebral injuries without spinal cord injury (control)

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Foundation Wings For Life

OTHER

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role collaborator

Unfallkrankenhaus Berlin

OTHER

Sponsor Role collaborator

Balgrist University Hospital

OTHER

Sponsor Role collaborator

I.R.C.C.S. Fondazione Santa Lucia

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role collaborator

Ruhr University of Bochum

OTHER

Sponsor Role collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

Marcel Kopp, MD

OTHER

Sponsor Role lead

Responsible Party

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Marcel Kopp, MD

Study Coordinator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jan M Schwab, MD, PhD

Role: STUDY_CHAIR

Ohio State University

Marcel A Kopp, MD

Role: STUDY_DIRECTOR

Charite University, Berlin, Germany

Central Contacts

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Marcel A Kopp, MD

Role: CONTACT

+49 30 450560075

Christian Blex, PhD

Role: CONTACT

+49 30 450560075

Other Identifiers

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SCIentinel-prolong

Identifier Type: -

Identifier Source: org_study_id

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