In this pilot study we want to investigate if 3D ultrasound can adequately visualize long nerve tracts and if 3D reconstructions of nerves and volumetric measurements can be made with this technique. If this is the case, this could not only decrease…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Several parameters will be evaluated in this study.
- CSA measurements obtained from the images acquired with 3D ultrasound.
- The quality of sonographic images of 3D ultrasound over a longer tract will
be evaluated semi-quantitatively following earlier published criteria.
- 3D reconstruction images (and the possibility of creating them in the three
groups of participants).
- Volumetric measurement values (and the possibility of obtaining them in the
three groups of participants).
- Inter-observer variability: the CSA measurements and volumetric measurements
obtained by 2 different investigators with 3D ultrasound will be compared. Also
the CSA measurements obtained with 3D and 2D ultrasound by one investigator
each will be compared.
Secondary outcome
NA
Background summary
High-resolution ultrasonography (HRUS) provides very useful information on
nerve pathology and is of diagnostic and prognostic value in polyneuropathies.
The most commonly assessed parameter in HRUS is measurement of the cross
sectional area (CSA), which is measured at a single plane of the nerve at a
predetermined measurement site. However, there seems to be a fair degree of
interobserver variability in CSA measurements and this may hinder performance
and interpretation of HRUS especially when sonography is used for follow-up
assessments of peripheral nerve pathology. Studies investigating MRI in
peripheral neuropathy showed that tumor volumetry was more reliable as a
follow-up tool than measuring CSA. In several fields of medicine 3D ultrasound
is used to gain additional insight in pathology, but research into this
technique when assessing peripheral nerves is very limited.
Study objective
In this pilot study we want to investigate if 3D ultrasound can adequately
visualize long nerve tracts and if 3D reconstructions of nerves and volumetric
measurements can be made with this technique. If this is the case, this could
not only decrease inter-observer variability in HRUS, by allowing more easy
recognition of the site of maximal enlargement for CSA measurement and by
measuring (changes in) nerve volume over a longer tract, but it could also give
additional insight in (spatial distribution of) nerve pathology, which could
have diagnostic, prognostic and therapeutic value in case of peripheral nerve
pathology.
Study design
This study is a cross-sectional pilot study, in which peripheral nerves of
several groups of patients will be examined with 3D-Ultrasound. Half of the
patients will undergo this investigation twice to determine inter-observer
variability of the techniek. The other half will undergo a 3D-Ultrasound and a
2D-Ultrasound in order to compare the two techniques.
Study burden and risks
The risks associated to participating are negligible. There are no known
harmful effects of ultrasonography or electrodiagnostic testing. 3D-ultrasound
is a technique that is not commonly used in neurology up to this date, but it
is already frequently applied in other fields of medicine, e.g. gynaecology.
There is a small burden for patients, since they need to invest time. We
believe this investment is justifiable to determine if 3D-Ultrasound of
peripheral nerves is useful, since this technique can have multiple
applications if that would be the case.
Hilvarenbeekse Weg 60
Tilburg 5000LC
NL
Hilvarenbeekse Weg 60
Tilburg 5000LC
NL
Listed location countries
Age
Inclusion criteria
- A diagnosis of CIDP, MMN, MIDN according to the international guidelines
or
- A diagnosis of axonal polyneuropathy, based on findings on EMG
or
- A diagnosis of NF1 according to the international guidelines, or genetically confirmed diagnosis of NF1
or
- Healthy control: participants without any neuropathic complaints (e.g. sensory loss, loss of strength);and
- Age 18-80
Exclusion criteria
- Being physically unable to undergo sonography
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 | NL61847.028.17 |