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
Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · Dec 30, 2016
Trial Information
Current as of June 13, 2025
Completed
Keywords
ClinConnect 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 the...
Gender
ALL
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).
About Centre Hospitalier Universitaire De Nice
The Centre Hospitalier Universitaire (CHU) de Nice is a leading academic medical center located in Nice, France, dedicated to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, CHU de Nice is committed to enhancing patient care by conducting rigorous studies that explore new therapies and treatment modalities across various medical disciplines. With a focus on collaboration, the center integrates cutting-edge technology and interdisciplinary expertise to ensure the highest standards of research integrity and patient safety. CHU de Nice plays a vital role in the development of evidence-based medicine, contributing significantly to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nice, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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