This project focuses on the characterization of the immune response following a traumatic SCI. As individual components of the immune response work in close collaboration and have a strong influence on each other, it is important to obtain a very…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Identification of the autoantibodies produced after SCI.
- Characterisation of the autoantibody response after SCI in patients over time.
- Assessment of the association between clinical outcome parameters and changes
in antibody levels: determining the prognostic biomarker potential of the
candidate biomarkers.
Secondary outcome
- Determine immune cell subtypes and function, immune derivatives, inflammatory
and neurological markers in peripheral blood at multiple time points following
spinal cord injury.
- Assessment of the association between the clinical outcome parameters and the
changes in immunological and neurological parameters in SCI patients.
Background summary
Worldwide, about 250,000 people suffer from a traumatic spinal cord injury
(SCI) each year. Inflammation plays an important role in the secondary injury
phase, that is characterized by further tissue degeneration. The immune
response following SCI has not been studied in humans. Therefore, the aim of
this project is to characterize the immune response following traumatic SCI. On
the one hand, the blood immune cell profile, inflammation and neurodegeneration
markers and immune derivatives will be measured. This will result in an
improved insight into the cellular immune response following SCI. On the other
hand, we will identify novel SCI-induced antibody biomarkers using a
high-throughput autoantibody profiling approach and further characterize these
novel markers. These antibody biomarkers will support the prediction of the
disease course following a traumatic SCI.
Study objective
This project focuses on the characterization of the immune response following a
traumatic SCI. As individual components of the immune response work in close
collaboration and have a strong influence on each other, it is important to
obtain a very detailed and elaborate overview of the immune response. Therefore
we will examine different aspects of the immune response in this project.
Hereby, autoantibodies, immune cell populations, immune components,
inflammatory and neurodegeneration markers will be investigated.
Study design
Longitudinal study
Study burden and risks
The risks are low. The risks of a blood donation are a temporary vasovagal
reaction or a local haematoma at the site of the puncture.
Martelarenlaan 42
Hasselt 3500
BE
Martelarenlaan 42
Hasselt 3500
BE
Listed location countries
Age
Inclusion criteria
- Age >= 18 years
- Recently diagnosed with SCI, i.e. not more than 8 weeks prior to admission to
the rehabilitation center
Exclusion criteria
- Incapacitated patients
- Patients with pre-existing autoimmune disorders
- Patients who receive anti-inflammatory or immune modulatory treatment (e.g.
corticosteroid administration)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72014.068.20 |
| Other | NL8803 bij www.trialregister.nl |