Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03008733 |
| Other study ID # |
16-AOIP-02 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 26, 2018 |
| Est. completion date |
September 30, 2021 |
Study information
| Verified date |
May 2022 |
| Source |
Centre Hospitalier Universitaire de Nice |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The use of nerve ultrasound for the diagnosis and monitoring of neuromuscular diseases is a
promising growing field (1). Non-invasive and painless, ultrasound provides additional data
electroneuromyography (EMG), with a spatial resolution at least as good as MRI, while being
easily accessible and inexpensive.The polyradiculoneuritis Inflammatory Demyelinating
Chronicles (IPDC), Neuropathies Motrices in Multifocal Conduction Blocks (NMMBC) and
neuropathy associated with anti-MAG antibodies are among the major chronic inflammatory
neuropathies with an autoimmune etiology. The diagnosis of these pathologies is based on the
clinic, diagnostic tests and EMG. The interest not only in the diagnosis, but also for
monitoring these pathologies using ultrasound analysis nerves has been demonstrated recently
in several studies. However the limited resolution of current ultrasound images do not allow
detailed study of the internal structure of the nerves which could later help deepen
knowledge in this innovative field and can better understand the pathophysiological mechanism
of the evolution of these pathologies .
To do this, the investigators have available a UHF ultrasound in the ultrasound department of
the Nice University Hospital Pasteur Hospital 2 The investigators realize a descriptive
analysis study, pilot, mono-centric, multi and prospective on patients followed in the center
with a diagnosis of IPDC, a NMMBC or neuropathy with anti-MAG antibodies and control subjects
matched by age and sex. All the patients and controls in this study will receive a briefing
and must sign an informed consent.
They realize an ultrasound study of the nerve, using an ultra high frequency ultrasound
system that will allow the assessment of anatomical structures of nerve (size, structure,
vascularisation and assessment booklets). Ultrasound data will, in a second stage, compared
with the data obtained with the EMG and clinical scores obtained using clinical rating
scales. 40 subjects will be included, divided into four subgroups: 10 subjects with a
diagnosis of IPDC (1), 10 subjects with a diagnosis of NMMBC (2), 10 subjects with a
diagnosis of neuropathy antibody-anti MAG (3) and 10 control subjects with no signs of
neuropathy at the EMG examination.
Description:
The use of nerve ultrasound for the diagnosis and monitoring of neuromuscular diseases is a
promising growing field (1). Non-invasive and painless, ultrasound provides additional data
electroneuromyography (EMG), with a spatial resolution at least as good as MRI, while being
easily accessible and inexpensive.The polyradiculoneuritis Inflammatory Demyelinating
Chronicles (IPDC), Neuropathies Motrices in Multifocal Conduction Blocks (NMMBC) and
neuropathy associated with anti-MAG antibodies are among the major chronic inflammatory
neuropathies with an autoimmune etiology. The diagnosis of these pathologies is based on the
clinic, diagnostic tests and EMG. The interest not only in the diagnosis, but also for
monitoring these pathologies using ultrasound analysis nerves has been demonstrated recently
in several studies. However the limited resolution of current ultrasound images do not allow
detailed study of the internal structure of the nerves which could later help deepen
knowledge in this innovative field and can better understand the pathophysiological mechanism
of the evolution of these pathologies .
To do this, the investigators have available a UHF ultrasound in the ultrasound department of
the Nice University Hospital Pasteur Hospital 2 The investigators realize a descriptive
analysis study, pilot, mono-centric, multi and prospective on patients followed in the center
with a diagnosis of IPDC, a NMMBC or neuropathy with anti-MAG antibodies and control subjects
matched by age and sex. All the patients and controls in this study will receive a briefing
and must sign an informed consent.
They realize an ultrasound study of the nerve, using an ultra high frequency ultrasound
system that will allow the assessment of anatomical structures of nerve (size, structure,
vascularisation and assessment booklets). Ultrasound data will, in a second stage, compared
with the data obtained with the EMG and clinical scores obtained using clinical rating
scales. 40 subjects will be included, divided into four subgroups: 10 subjects with a
diagnosis of IPDC (1), 10 subjects with a diagnosis of NMMBC (2), 10 subjects with a
diagnosis of neuropathy antibody-anti MAG (3) and 10 control subjects with no signs of
neuropathy at the EMG examination.
The main objective of this pilot study is to provide a descriptive analysis of the morphology
of the nerves with an ultra high frequency ultrasound in subgroups of CIDP patients, anti-MAG
antibodies and neuropathy NMMBC and controls. The thickness of the epineurium, the hallmarks
of fascicular organization, Doppler vascularity, the nerve-sectional area, the specification
of the section surface, nerve hypertrophy, the thickness of the perineurium and
ultrastructural characterization of the different fascicular organization typologies will be
well analyzed in order to better understand the specific sonographic characteristics of each
disease compared with controls, no data exist at present in the literature with such image
resolution.
Secondary objectives:
1. Compare the morphological characteristics obtained by ultra high frequency ultrasound
between different subjects subgroups according to the morphological data collected and
sonographic scores: evaluation of nerve hypertrophy (intra- and inter-ratio nerve nerve)
(4 ) and intra-fascicular nerve and nerve cross-ratio.
2. To study the correlation between sonographic and clinical scores scores in different
subjects subgroups using functional assessment scales: MRC score, R-ODS score, INCAT,
ONLS, ataxia Score and a torque rating of grip strength.
3. To study the correlation between sonographic scores and electrophysiological scores by
making a électroneurogramme (ENG) in the different subjects of subgroups: the amplitude
and distal motor latency for distal motor conduction, the motor conduction velocities,
the presence of time dispersion or of a conduction block to the stepped motor
conduction, the latency of the waveform F to the proximal motor conduction and the
amplitude of the sensory potential for sensory conduction.
