Gain insight in the anatomy and organisation of the sacral plexus in children with NB and congenital spinal or sacral anomalies. Possible findings can be compared with the results of the healthy subjects, in order to be able to relate findings to…
ID
Source
Brief title
Condition
- Neurological disorders congenital
- Spinal cord and nerve root disorders
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the anatomy and organisation of the sacral
plexus in the patient population in comparison to the organisation in healthy
individuals (from study 10/418). In order to be able to answer this question,
the anatomy and organisation of the sacral plexus in the patient group will be
compared qualitatively with the gained anatomical knowledge of the sacral
plexus from the previous healthy subject study. The hypothesis is that in
children with Spina Bifida a disrupted organisation of the nerves will be
revealed. In children with sacral agenesis a disrupted course of the nerves is
expected, because the sacrum has a disrupted development.
In order to further validate and quantify findings regarding anatomy and
organization of the sacral plexus, two secondary parameters will also be used,
these are described below.
Secondary outcome
1) The anatomy of nerve branching in the sacral plexus
Branching of the nerve root is analyzed: no branching, branching in two
branches or plexiform branching of the nerve root. This outcome will be related
to the healthy subjects quantitatively by means of comparative statistics.
2) Determining the ADC, FA, AD and RD
The parameters mentioned above will be used to quantify the DTI images.
Molecular diffusion in the nerves can be characterized with these parameters.
Furthermore, quantitative comparison between the values for these parameters
and the reference values of the healthy subjects is possible. However,
myelinisation differences between children and adolescents, and the influence
of these differences on the parameters, need to be taken into account in
comparison between both groups. ExploreDTI by Alexander Leemans (Image Science
Institute, Utrecht), will be used to measure ADC, FA, AD and RD.
The number of images we're not able to analyse will also be determined.
Background summary
Neurogenous bladder- and sphincter dysfunction (neurogenous bladder, NB), is a
commonly seen pathology in Paediatric Urology. Training is not possible in NB,
and NB has severe long-term outcomes on functioning of the bladder and higher
urinary tracts. An extensive treatment regime, aiming at preserving kidney
function and treating the, common, incontinence, is necessary in this patient
group. Children with Spina Bifida, Sacral Agenesis or other congenital
anomalies of sacrum or spinal cord are almost always diagnosed with NB, based
on anatomical anomalies in innervation. Not much is known about the exact
pattern of abnormal innervation in this patient group, and many anatomical
variations have not yet been mapped.
The hypothesis of this research is that mapping anatomical variations in
innervation of the bladder will gain insight in the causes of NB and treatment.
MRI is known for its superior soft-tissue contrast. Conventional T1-weighted
sequences are not useful in imaging long trajectories of nerves. Previous
studies have been conducted to imaging of peripheral nerves with DWI and DTI
sequences. The first results are promising, however low spatial resolution is a
drawback of these sequences. This problem can partly be overcome by imaging at
higher field strengths. Isotropic 3D sequences have also been researched for
imaging the sacral plexus.
In a previous study in healthy subjects (protocol number 10/418) the
combination of TSE with variable flip angles and DTI with tractography were
found to be the most optimal sequences in visualizing the anatomy and
organisation of the sacral plexus.These sequences will also be used in this
research.
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Study objective
Gain insight in the anatomy and organisation of the sacral plexus in children
with NB and congenital spinal or sacral anomalies. Possible findings can be
compared with the results of the healthy subjects, in order to be able to
relate findings to urodynamic functioning of baldder and sphincter and clinical
manifestations.
Study design
Cross-sectional monocenter study. The patient group consists of ten childres
diagnosed with congenital spinal or sacral anomalies and NB. Children which are
scheduled to have a MRI scan for diagnostical reasons are included in this
study. The resulting images will be analyzed and compared to the results from
the healthy subjects.
MR Imaging will be performed on a 3T MRI-scanner (Philips Medical Systems,
Best). The scan will be made in the supine position. The small pelvic region
(caudally onwards from L4) will be imaged. The DTI-sequence will be based on
single-shot EPI DWI, with b-values 0 and 800 s/mm2, with gradients in 15
directions. A 3D TSE sequence with variable flip angles will also be made. In
this sequence. protons are brought in a pseudo steady state, after which very
low flip angles (=< 15') will be used. The total scan time is approximately 30
minutes.
Study burden and risks
No risks or side-effects of MRI are known, other than temporary dizzyness or
claustrofobic anxiety. The research is relatively noninvasive and no contrast
agent is needed.
Total scan time is estimated at 30 minutes.
Lundlaan 6
3508AB Utrecht
NL
Lundlaan 6
3508AB Utrecht
NL
Listed location countries
Age
Inclusion criteria
age > 8 years
diagnosed with spinal dysraphism or sacral anomalies and neurogenous bladder which are already scheduled to have a MRI scan for diagnostic reasons.
Parents/guardian and child >12 years need to be able and willing to sign informed consent
Exclusion criteria
contra indication of MRI (i.e. claustrofobia, pacemaker)
Parents/guardian and child don't want to be informed of accidental findings
Children of employees of the divisions Paediatric Urology and Radiology of the UMC Utrecht
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 | NL39561.041.12 |