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

February 6, 2023 updated by: Marcel Kopp, MD

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • BG Hospital Unfallkrankenhaus Berlin, Treatment Centre for Spinal Cord Injuries
        • Contact:
          • Thomas Liebscher, MD
  • Italy
      • Rome, Italy
        • Center for Neurorehabilitation, Santa Lucia Foundation
        • Contact:
          • Marcella Masciullo, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants from primary care clinics

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 months (10-14 weeks) post injury

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
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
2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
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
2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
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
2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
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.
2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
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
2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
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
2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
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
2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
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
2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
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
2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
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
2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
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
2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
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
2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
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
2 weeks, 3-6 weeks, 3 month, 6month, 1 year post injury
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
2 weeks, 3 months
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
2 weeks, 3 months
Electroneurography
Time Frame: 2 weeks, 3 months
Abductor hallucis and abductor digiti minimi; latency, amplitude and F-waves
2 weeks, 3 months
Sympathetic skin response
Time Frame: 2 weeks, 3 months
Skin response at palm and sole
2 weeks, 3 months
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
1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury
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
1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury
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
1 day, 3 days, 1week, 2 weeks, 3-6 weeks, 3 months, 6 months, 1 year post injury
Damage Associated Molecular Patterns
Time Frame: 1week, 3 months,
Immunoassays in plasma and CSF
1week, 3 months,
Markers of Ferroptosis
Time Frame: 1week, 3 months
Immunoassays in plasma and CSF
1week, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marcel Kopp, MD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
King's College London
Medical University of Vienna
University of Zurich
McGill University Health Centre/Research Institute of the McGill University Health Centre
Ohio State University
Ruhr University of Bochum
University Hospital Tuebingen
Balgrist University Hospital
I.R.C.C.S. Fondazione Santa Lucia
Swiss Federal Institute of Technology
Foundation Wings For Life
Unfallkrankenhaus Berlin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SCIentinel-prolong

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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