1. To study reproducibility of a qualitative scale for abnormality of brachial plexus MRI.2. To study usefulness of quantification of nerve size using maximum intensity projection techniques (MIP) , and compare results with HRUS of the brachial…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters for objective 1, are:
1. (Semi-)quantitative rating of MRI-imaging of brachial plexus.
2. Cross-sectional area (CSA) on HRUS imaging (CSA measurements of median
nerves and brachial plexus).
These parameters will be used to select those with highest diagnostic yield as
endpoint.
The main parameters for objective 2, are:
1. MRI-DTI values (radial, axial and mean diffusivity (RD, AD and MD),
fractional anisotropy (FA)).
The will be used to determine the distribution of parameters and nerve size
that may be useful in the future for patients with CIDP and MMN.
Secondary outcome
NA
Background summary
Chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor
neuropathy (MMN) are rare causes of lower motor neuron syndromes that respond
to treatment. Extensive nerve conduction studies (NCS) to detect abnormalities
that suggest demyelination or conduction block (CB) are often burdensome. The
required specific expertise is another drawback. Abnormal qualitative magnetic
resonance imaging (MRI) of the brachial plexus is a supportive criterion for a
diagnosis of MMN and CIDP. Its specificity is excellent but sensitivity is
limited. Potential improvements for MRI-imaging include quantitative analysis
and advanced MRI-sequences. MRI-DTI techniques also have potential to clarify
the pathophysiology of inflammatory neuropathies.
Study objective
1. To study reproducibility of a qualitative scale for abnormality of brachial
plexus MRI.
2. To study usefulness of quantification of nerve size using maximum intensity
projection techniques (MIP) , and compare results with HRUS of the brachial
plexus.
3. To study feasibility of an MRI-DTI protocol for nerve(root)s in upper arm
and brachial plexus in healthy controls and patients with MMN, CIDP. These
techniques may be new tools to gain insight in pathophysiology and/or treatment
response
Study design
To study objective 1 and 2, a cross-sectional study will be used to define
quantitative cut-off values of abnormal nerve size of the brachial plexus and
to select parameters with the highest diagnostic yield. A cross-sectional
design will also be used to study objective 3, whether MRI-DTI parameters (i.e.
altered diffusivity in radial and axial dimensions) are specific for CIDP and
MMN. To study objective 4 we use a longitudinal design to explore whether
MRI-DTI could be used as a biomarker for treatment response.
Study burden and risks
For the purpose of this project, patients will only have to undergo MRI. It
offers little burden additional to the routine diagnostic procedures. MRI is
safe, non-invasive and well tolerated. To minimize the hospital visits,
neuro-imaging sessions will be planned in combination with the routine
diagnostic procedures.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
1. Age 18- 80 years.
2. Patients: confirmed diagnosis of CIDP or MMN, as defined by relevant
diagnostic consensus criteria.
3. Disease controls: established diagnosis of relevant clinical mimic to
diagnosis CIDP and MMN (CMT, lower motor neuron syndromes and axonal
neuropathies).
4. Healthy volunteers: no previous diagnosis, sign/symptoms consistent with
neuropathy
Exclusion criteria
1. age <18 or >80 years,
2. physically unable to undergo MRI or HRUS of the peripheral nervous system
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 | NL62866.041.17 |