Descriptive Analysis of Morphological Aspects of Nerve by Ultra-high Frequency Ultrasound (30-50MHZ) in Demyelinating Neuropathies: Inflammatory Demyelinating Polyneuropathy Chronic (IPDC), Neuropathy Multifocal Motor Block of Conducting (NMMBC) and Neuropathy With Antibody A MAG

NCT03008733 | Completed

• 1 other identifier: 16-AOIP-02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Outcome Measures

Primary Outcomes (1)

• morphology of the nerves by means of an ultra-high frequency ultrasound in patients subgroups CIDP, anti-MAG antibodies and NMMBC neuropathy and control subjects.

  through study completion an average of 3 years

Study Arms (4)

NMMCB

ACTIVE COMPARATOR

patient with Neuropathies with Motrices Multifocal Conduction Block

Other: Ultrasound UHF peripheral nerves; Other: Electro myography surface nerves

PICD

ACTIVE COMPARATOR

patient with Inflammatory demyelinating polyneuropathy Chronicle

Other: Ultrasound UHF peripheral nerves; Other: Electro myography surface nerves

anti MAG

ACTIVE COMPARATOR

patient with neuropathy antibody Anti-MAG

Other: Ultrasound UHF peripheral nerves; Other: Electro myography surface nerves

healthy

PLACEBO COMPARATOR

healthy patient

Other: Ultrasound UHF peripheral nerves; Other: Electro myography surface nerves

Interventions

Ultrasound UHF peripheral nerves OTHER

Ultrasound UHF peripheral nerves

NMMCB; PICD; anti MAG; healthy

Electro myography surface nerves OTHER

Electro myography surface nerves

NMMCB; PICD; anti MAG; healthy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or woman age ≥ 18 years.
• Affiliation to social security.
• Signature of informed consent.
• \- Patients with certain IPDC according to the following criteria defined by the EFNS 2010:
• At least one of demyelination following criteria must be present:
• Extension of the Distal Motor Latency ≥ 50% above the limit Normale Supérieure (LNS) in 2 nerves (excluding impairment of the median nerve at the wrist due to carpal tunnel syndrome);
• Reducing the speed of conduction Average ≥ 30% below the normal limit Lower (LNI) in 2 nerves;
• Extension of the latency of the F wave ≥ 30% above the ULN in two nerves (≥ 50% of the LNS if the amplitude of distal negative peak PAGM (Action Potential Global Muscle) is \< 80% of the LNI;
• Lack wave F in 2 nerves if these nerves have an amplitude of the negative peak of the distal PAGM ≥ 20% of the LNS + ≥ 1 other parameter of demyelination in \* ≥ 1 other nerve;
• Conduction Block partial engine: decreased range ≥ 50% of the negative peak of the proximal to the distal PAGM PAGM, if the negative peak of the distal PAGM ≥ 20% LNI in 2 nerves or nerve + 1 ≥ 1 another parameter of demyelination in ≥ 1 \* other nerve;
• abnormal temporal dispersion (\> 30% increase in duration between the negative peak of the proximal and distal PAGM) ≥ 2 in nerves;
• PAGM distal length (interval between the start of the negative peak and its return to baseline) in ≥ 1 nerve (median ≥ 6.6 ms, ulnar ≥ 6.7 ms ≥ 7.6 ms peroneal, tibial ≥ 8.8 ms) + 1 ≥ another parameter \* demyelination in ≥ 1 other nerve.
• Patients with certain NMMBC according to the following criteria defined by the EFNS (2010):
• Weak slowly progressive or progressive members in spurts, and focal asymmetric, due to damage of the driving motor nerve distribution in at least two nerves, for over a month.
• Lack of objective sensory abnormality except for sensory anomalies minor vibrations in the lower limbs.

You may not qualify if:

• Presence of risk factors associated neuropathic disease (diabetes, chronic alcoholism, kidney failure, HIV status, Lyme disease, vasculitis or any other factor which, in the judgment of the investigator, could pose a risk).
• A patient pathology judged by the investigator as interfering with the proper conduct of the study.
• Positive pregnancy test. A urine pregnancy test will be performed for women of childbearing age. Results will be communicated to the patient by a doctor of his choice.
• Refusal of the subject to participate in the study.
• Topic guardianship or curatorship.
• Inability of the subject to cooperate.
• No affiliation to a social security scheme (beneficiary or assignee).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06000, France

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: January 2, 2017
• Study Start: June 26, 2018
• Primary Completion: December 31, 2020
• Study Completion: September 30, 2021
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)