No registrations found.
ID
Source
Brief title
Health condition
Spinal cord injury, biomarkers, MRI-DWI
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
N/A
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
Prospective study determing whether MRI-Diffusion Weighted Imaging (DWI) and biomarkers in CSF have prognostic capabilities in patients with Spinal Cord Injury (SCI).
Study design
- MRI-DWI within 24 hours after the initial trauma
- A CSF sample within 72 hours after the initial trauma
Intervention
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 cerebrospinal fluid (CSF) sample will be taken
Department of Orthopaedic surgery
PO Box 9101
M.H. Pouw
Nijmegen 6500 HB
The Netherlands
+31 (0)24 3613918
M.Pouw@orthop.umcn.nl
Department of Orthopaedic surgery
PO Box 9101
M.H. Pouw
Nijmegen 6500 HB
The Netherlands
+31 (0)24 3613918
M.Pouw@orthop.umcn.nl
Inclusion criteria
1. Closed spinal cord injury
2. Associated neurologic deficit
3. Primarily referred to UMC St. Radboud
4. Glasgow Coma Scale of 15
Exclusion criteria
1. Penetrating spinal cord injury
2. Normal neurologic examination
3. Ischaemic spinal cord injury
4. Traumatic brain injury
5. 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 |
|---|---|
| NTR-new | NL1323 |
| NTR-old | NTR1381 |
| Other | UMCN St Radboud : UMCN-2008 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |