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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 (EchoNerf)

Primary Purpose

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasound UHF peripheral nerves
Electro myography surface nerves
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

common inclusion criteria for all subjects:

  • Man or woman age ≥ 18 years.
  • Affiliation to social security.
  • Signature of informed consent.

Inclusion criteria for CIDP patients:

- 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.

Inclusion criteria for patients NMMBC:

  • 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.
    • In a nerve:
  • conduction block some engine.
  • Conduction normal sensory nerves in the segments of the upper limbs with conduction block.

    • No evidence of upper motor neuron.
    • Lack of significant bulbar weakness.
    • Sensory impairment less marked than the minor loss of sensitivity to vibrations in the lower limbs.
    • symmetrical weakness Lack broadcasts during the first weeks.

Inclusion criteria for the neuropathy patients with anti-MAG antibody:

- Patients with neuropathy with anti-MAG antibody according to criteria defined by the EFNS (2010):

  • electrophysiological criteria:

    • symmetrical uniform reduction of conduction velocity; more severe at that sensory motor.
    • Distal Motor Latency disproportionately long: Index of Distal Latency ≤ 0.25.
    • Potential sural missing.
  • Clinical criteria:

    • Early disease> 50 years.
    • ataxia associated with shaky hands.
  • Biological criteria:

    • IgM monoclonal rate lower than 10 g / l, or greater than 10 g / l in the context of Waldenström's macroglobulinemia.
    • Presence of anti-MAG antibody (Myelin-Associated Glycoprotein).

Exclusion Criteria:

  • 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).

Sites / Locations

  • CHU de Nice

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

NMMCB

PICD

anti MAG

healthy

Arm Description

patient with Neuropathies with Motrices Multifocal Conduction Block

patient with Inflammatory demyelinating polyneuropathy Chronicle

patient with neuropathy antibody Anti-MAG

healthy patient

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2016
Last Updated
May 5, 2022
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT03008733
Brief Title
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
Acronym
EchoNerf
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NMMCB
Arm Type
Active Comparator
Arm Description
patient with Neuropathies with Motrices Multifocal Conduction Block
Arm Title
PICD
Arm Type
Active Comparator
Arm Description
patient with Inflammatory demyelinating polyneuropathy Chronicle
Arm Title
anti MAG
Arm Type
Active Comparator
Arm Description
patient with neuropathy antibody Anti-MAG
Arm Title
healthy
Arm Type
Placebo Comparator
Arm Description
healthy patient
Intervention Type
Other
Intervention Name(s)
Ultrasound UHF peripheral nerves
Intervention Description
Ultrasound UHF peripheral nerves
Intervention Type
Other
Intervention Name(s)
Electro myography surface nerves
Intervention Description
Electro myography surface nerves
Primary Outcome Measure Information:
Title
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.
Time Frame
through study completion an average of 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: common inclusion criteria for all subjects: Man or woman age ≥ 18 years. Affiliation to social security. Signature of informed consent. Inclusion criteria for CIDP patients: - 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. Inclusion criteria for patients NMMBC: 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. In a nerve: conduction block some engine. Conduction normal sensory nerves in the segments of the upper limbs with conduction block. No evidence of upper motor neuron. Lack of significant bulbar weakness. Sensory impairment less marked than the minor loss of sensitivity to vibrations in the lower limbs. symmetrical weakness Lack broadcasts during the first weeks. Inclusion criteria for the neuropathy patients with anti-MAG antibody: - Patients with neuropathy with anti-MAG antibody according to criteria defined by the EFNS (2010): electrophysiological criteria: symmetrical uniform reduction of conduction velocity; more severe at that sensory motor. Distal Motor Latency disproportionately long: Index of Distal Latency ≤ 0.25. Potential sural missing. Clinical criteria: Early disease> 50 years. ataxia associated with shaky hands. Biological criteria: IgM monoclonal rate lower than 10 g / l, or greater than 10 g / l in the context of Waldenström's macroglobulinemia. Presence of anti-MAG antibody (Myelin-Associated Glycoprotein). Exclusion Criteria: 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).
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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