Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03008733
Study type Interventional
Source Centre Hospitalier Universitaire de Nice
Contact
Status Active, not recruiting
Phase N/A
Start date June 26, 2018
Completion date September 30, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT02271724 - sCD163 & CD19 as Candidate Biomarkers in CIDP and MMN N/A
Completed NCT00004772 - Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Chronic Inflammatory Demyelinating Polyneuropathy Phase 3
Completed NCT02027701 - Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Phase 3
Recruiting NCT03275740 - A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347 Phase 1
Not yet recruiting NCT04978623 - Role of High Frequency Ultrasound in Demyelinating Polyneuropathies
Completed NCT00004286 - Phase III Multicenter Double Blind Controlled Trial of Human Immune Globulin Therapy in Previously Untreated Patients With Chronic Inflammatory Demyelinating Neuropathy Phase 3
Recruiting NCT04742374 - Effects of Single Plasma Exchange and Double Filtration Plasmapheresis (DFPP) on Peripheral Lymphocyte Phenotypes in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy Early Phase 1
Completed NCT00305266 - Study of CIDP Patients During IVIG Treatment N/A
Completed NCT00004939 - Phase III Randomized, Double-Blind, Placebo-Controlled Study of 3,4-Diaminopyridine for Demyelinating Polyneuropathy Phase 3
Completed NCT01017159 - Subcutaneous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Phase 2
Completed NCT00220740 - Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Phase 3