To visualize the affected nerve roots using DTI with tractography. The anatomy and organisation of the nerves on the level of the lumbar disc herniation will be visualized. Diffusion parameters as FA, ADC, AD, and RD could provide valuable…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The apparent diffusion coefficient (ADC), fractionele anisotropie (FA), axiale
diffusiviteit (AD), and radiale diffusiviteit (RD) will be measured. The
program ExploreDTI (©: Alexander Leemans) will be used to visualize these
nerves. With this it will be examined whether it is possible to characterize
the diffusion of the molecules in the nerve tissue. The ADC, FA, AD, and RD
will be measured in the DTI images using the program ExploreDTI of Alexander
Leemans, working in the UMCU at the Image Science Institute (ISI). The
hypothesis is that the diffusion parameters of the affected nerve root on the
level of the lumbar disc herniation will differ from the contralateral nerve
root. This will be verified by comparing them to nerve roots in healthy
volunteers. This will also indicate whether or not the herniated disc will
affect the diffusion parameters and anatomy of other nerve roots in the
patient.
Secondary outcome
The secundary research variable is the anatomy and functionality on the level
of the lumbar disc herniation and the nerve roots in comparison to the healthy
contralateral side. To be able to answer this the research question we would
like to visualize the anatomy and organisation of the nerves of this group of
patients, where we want to compare the affected nerves and the healthy nerves
qualitatively. Our hypothesis is that the nerves on the level of the lumbar
disc herniation will be disturbed. To identify whether or not the hernia does
not affect other nerve roots in the patients the results will be compared to
the nerve root organisation of healthy volunteers. In case this correlation is
identified the information of healthy volunteers will also be used to indicate
in what way the hernia affect other nerve roots.
Background summary
Neurogenic bladder dysfunction (NBD) is common within the peadiatric urology.
The exact mechanism which disturbs this innovation of the bladder of these
children remains unknown. The anatomical variations have not been described in
literature. Diffusion parameters as the fractional anisotropy (FA), Apparent
Diffusion Coefficient (ADC), Axiale Diffusivity (AD) and Radiale Diffusivity
(RD) could provide information about the functionality of the nerves. Earlier
studies have investigated the possibilities of visualizing the periferal nerves
using Magnetic Resonance Imaging (MRI) in the combination with Turbo Spin Echo
(TSE) and Diffusion Tensor Imaging (DTI) with tractography sequences. Both
healthy subjects (protocol number 10/418) as children with spina bifida
(protocol number 12-063) have been included. Research where healthy subjects
were included showed that it was feasible to visualize the lumbar and sacral
plexus using DTI and to measure the diffusion parameters. In the research where
spina bifida patients are included the periferal lumbar and sacral nerves were
also visualized and the diffusion parameters were measured. However, this group
involves many complex cases, through which it is difficult to obtain one
overall result whether the nerves are damaged or not. Another complication
consists of the broad anatomical variance within this group. Therefore a more
simple model has been chosen to indicate the diagnostic value of DTI as a
diagnostic technology to visualize the nerve roots and to measure the diffusion
parameters of these nerve roots. For this the lumbar disc herniation will be
used. Lumbar disc herniation is a medical condition affecting the spine in
which a tear in the outer, fibrous ring of an intervertebral disc allows the
soft, central portion (nucleus pulposus) to bulge out beyond the damaged outer
rings. This is oftend accompanied with intense pain, sciatica. The incidence of
sciatica is estimated to be 13-40%.
Study objective
To visualize the affected nerve roots using DTI with tractography. The anatomy
and organisation of the nerves on the level of the lumbar disc herniation will
be visualized. Diffusion parameters as FA, ADC, AD, and RD could provide
valuable information to what extent the nerves are damaged and disfunctional.
The contralateral side will be used as a reference. A group of healthy subjects
will be included as well. This will provide more insight in the organisation of
the nerve roots and will be used to indicate whether or not the herniated disc
will affect the diffusion parameters and anatomy of other nerve roots in the
patient.
Study design
Cross-sectional study within one University Medical Center. 10 patients
suffering from lumbar disc hernation are included. They will be scanned with
the MRI in the University Medical Center at the department of Radiology. The
MRI images will be examined and will be compared to the contralateral nerve
root. Furthermore, 10 healthy volunteers will be included. This will provide
more insight in the organisation of the nerve roots and will be used to
indicate whether or not the herniated disc will affect the diffusion parameters
and anatomy of other nerve roots in the patient.
Study burden and risks
There are no known riscs associated with MRI, other then dizziness, or
claustrofobia. The burden of this research is relatively low as there is no
need to use a contrast agent. The additional total scan time of this research
is 5 minutes. The total scan time of healthy adults is 15 minutes.
Heidelberglaan 100
Utrecht 3508 GA
NL
Heidelberglaan 100
Utrecht 3508 GA
NL
Listed location countries
Age
Inclusion criteria
Patients
- Patients suffering from lumbar disc herniation
- Symptoms associated with sciatica coming from compressed disfunctional nerves at the level of L3 - S1
- Patients < 60 years;Healthy subjects
- Volunteer must me healthy
- Volunteer must be older than 18 years
- Volunteer must be willing to sign informed consent
Exclusion criteria
Patients
- Patients with pervious history of spinal trauma, surgery or neurological disease
- Patients with previous history of malignancies
- Patients with previous radicular syndrom
- Patients with other back problems
- Patients with a contraindication to MRI (i.e. pacemaker);Healthy subjects
- Volunteers with a contraindication to MRI (i.e. pacemaker)
- Volunteers who do not want to be informed about potential findings related to their health
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 | NL43311.041.13 |