The purpose of the this study is to evaluate the prognostic capabilities of DWI and biomarkers in CSF in patients with SCI.
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1 Size of the lesion (hemorrhage, edema, contusion) in the spinal cord measured
in millimetres using MRI
2 Size of the lesion (hemorrhage, edema, contusion) in the spinal cord measured
in millimetres using DWI
3 The values of Apparent Diffusion Coefficients (ADC) in the lesion and in
normal spinal cord in 10-3 mm2/s measured using DWI
4 The concentrations of Neuron Specific Enolase, Glial Fibrillary Acidic
Protein, S-100ß, Neurofilament Protein, Tau and Myelin Basic Protein in CSF in
patients with SCI.
5 Evaluation of the ASIA classification system and SCIM of all patients at
different times
Secondary outcome
is not applicable
Background summary
Magnetic Resonance Imaging (MRI) is still the technique of choice for the
evaluation of spinal cord injury (SCI). MRI however has limited succes as a
prognostic tool.
Diffusion-weighted MRI (DWI) has been proposed as a method to evaluate the
integrity of microstructural changes in the spinal cord. Besides spinal cord
imaging there is a method for the assesment of spinal cord injury using
biomarkers in cerebrospinal fluid (CSF).
Study objective
The purpose of the this study is to evaluate the prognostic capabilities of DWI
and biomarkers in CSF in patients with SCI.
Study design
In this prospective cohort study the data are collected of all patients with
SCI. The following descriptive data are collected: mechanism of injury,
clinical data and radiological findings using conventional radiographs and
computed tomography.
Within 24 hour after the initial trauma all patients with SCI recieve a MRI and
a DWI examination.
Within 72 hours after the initial trauma all patients with SCI will be operated
on the cervical and/or thoracic spinal cord.
During this operation a 3 ml CSF sample will be taken
Throughout the rehabilitation and during admission the SCIM (Spinal Cord
Impairment Measurement) and the ASIA (American Spinal Injury Association)
classification system will be evaluated. This will be evaluated until 12 months
after the initial trauma.
Study burden and risks
The DWI examination will last 1-2 minutes. During this examination a minimum of
one nurse will be present throughout the examination. Hemodynamic unstable
patients will be accompanied by an anesthesiologist and/or traumatologist.
The spinal puncture will be performed during the operation. Patients will be
completely sedated. Therefore, the burden of this spinal puncture is restricted
to a minimum.
It is the opinion of this research group that the possible advantages of DWI
and biomarkers for future patients with SCI outweigh the minimal disadvantages
of these diagnostic tests.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
closed spinal cord injury
associated neurologic deficit
primarily referred to UMC St. Radboud
Glasgow Coma Scale of 15
Exclusion criteria
penetrating spinal cord injury
normal neurologic examination
ischaemic spinal cord injury
traumatic brain injury
pre-existent neurological disorder
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 | NL20061.091.07 |