Role of High Frequency Ultrasound in Demyelinating Polyneuropathies

Chronic Inflammatory Demyelinating Polyradiculoneuropathy Clinical Trial

Official title:

Descriptive Analysis of Morphological Aspects of Nerve Fibers in Demyelinationg Polyneuropathies Using HIGH FREQUENCY Ultrasound

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04978623
• Other study ID #: 21neuroperiph01
• Status: Not yet recruiting
• Start date: January 1, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: July 2021
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Angela PUMA, PHD
• Phone: 33492035435
• Email: puma.a[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The use of neuroimaging in the evaluation of neuromuscular pathologies is a promising and rapidly expandinf field. Among the different imaging techniques employed, nerve ultrasound is of particular interest given it's non invasivity, lack of side effects, accesibility and low cost. This exam provides complementary data to electroneuromyography (ENMG), enabeling the physician to visualise the morphological correspondents of electrophysiological abnormalities with a spatial resolution at least as good as MRI.

Chronic Inflammatory Demyelinating Polyradiculoneuritis (CIDP), Multifocal Motor Neuropathy with Conduction Blocks (MMNBC), Lewis and Sumner syndrome (L-S syndrome) and anti-MAG antibody-associated neuropathies (anti-MAG) are among the main chronic inflammatory neuropathies of autoimmune etiology. The diagnosis of these diseases is based on clinical, paraclinical and ENMG examinations. Several recent studies have highlighted the valuable role of ultrasound not only in the diagnosis but also for follow up of patients afflicted by this group of diseases.

However, the current ultrasound imaging techniques does not allow for a detailed study of the internal structure of the nerves. The developement of technologies with improved resolution contribute to further the knowledge in this innovative field and to better understand the pathophysiological mechanisms responsible for initiation and progression of inflammatory nerve disorders.In the Department of Ultrasound at the Nice University Hospital in France the team have at its disposal a high frequency untrasound that the team use to explore the peripheral nervous system.

The scientific hypothesis of this pilot study rests on the premise that demyelinationg neuropathies are a heterogenous group where different types present with different morphological characteristics not only at the level of the nerve as a whole, but also at the level of the nerve fascicles and of the peri- and intra-neural vascular structures. In this respect, high frequency ultrasound allows us to visualise different segments of affected nerves and to obtain morphological details which the team then compare with existing ultrasound data in the literature (high frequency ultrasound: 10-20 MHz). Thanks to this non-invasive and painless technique, the nerve can be rapidly visualised along its entire length in static and dynamic mode. In addition, high frequency ultrasound will give us access to complementary data on the morphology of the soft tissues and the peri- and intra-neural vascular structures which may be useful in shedding light on the underlying pathophysiologycal processes. Another important aspect is the opportunity to make electromyographic and clinical correlations The main parameter The team will study in ultrasound will be hypertrophy, corresponding to an increase in the cross-sectional area of the nerve. the team will also conduct analysis on other less codified parameters, such as epineural and endoneural vascularisation (using the Doppler mode), as well as nerve fascicles anatomy (size, organisation). Identification of different characteristics may be of diagnostic interest in cases where the clinical, paraclinical and ENMG examinations do not allow us to make a diagnostic and therapeutic decision, but it can also prove useful in the follow-up of patients and response to treatment.

This is a descriptive, pilot, mono-centric, multiparametric and retrospective analysis study on patients followed in our centre with a diagnosis of CIDP, NMMBC, L-S syndrom and anti-MAG

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female,

• 18 years of age or older

• Patients with CIDP or NMMBC or definite anti-MAG neuropathy according to the criteria defined by EFNS 2010

• Signing of an informed consent.

• Affiliation or beneficiary of the social security system

Exclusion Criteria:

• Subjects with a medical condition deemed by the investigator to interfere with the proper conduct of the study.

• Positive pregnancy test.

• Pregnant or breastfeeding woman (a urine pregnancy test will be performed for women of childbearing age) A urine The results will be communicated to the patient by a doctor of her choice.

• Persons deprived of their liberty by a judicial or administrative decision;

• Persons hospitalised without consent;

• Persons of full age who are subject to a legal protection measure or who are unable to express their consent.

• Incapacity of the subject to cooperate.

Related Conditions & MeSH terms

• Chronic Inflammatory Demyelinating Polyradiculoneuropathy
• Polyneuropathies
• Polyradiculoneuropathy
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

Other:
• high frequency ultrasound
high frequency ultrasound in subgroups of patients with CIDP, anti-MAG, NMMBC and L-S syndrome

Locations

Country	Name	City	State
France	Nice University Hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of nerve size using high frequency ultrasound	Size of cross section area (CSA) (mm) mesured in trasversal section of median and ulnar nerves at wrist, elbow and middle arm	24 months
Secondary	correlation between ultrasound data and clinical data	The study of the correlation between ultrasound data (CSA) and clinical data (degree of functional impairment caused by the neuropathy) will be carried out on the basis of motor deficit score obtained by using functional assessment scales and filling in a self-questionnaire: - MRC-score allowing the assessment of the motor deficit. -	24 months
Secondary	correlation between ultrasound data and clinical data	The study of the correlation between ultrasound data (CSA) and clinical data (degree of functional impairment caused by the neuropathy) will be carried out on the basis of sensory deficit score obtained by using functional assessment scales and filling in a self-questionnaire: - INCAT for the evaluation of sensory deficit.	24 months
Secondary	Correlation between ultrasound data and electrophysiological data	The study of the correlation between the ultrasound data and the electrophysiological data will be carried out on the basis of the ultrasound scores obtained at the level of the predefined nerves and observation sites: - Distal latency (in milliseconds);	24 months
Secondary	Correlation between ultrasound data and electrophysiological data	The study of the correlation between the ultrasound data and the electrophysiological data will be carried out on the basis of the ultrasound scores obtained at the level of the predefined nerves and observation sites: - Motor conduction velocity (in m/s);	24 months
Secondary	Correlation between ultrasound data and electrophysiological data	The study of the correlation between the ultrasound data and the electrophysiological data will be carried out on the basis of the ultrasound scores obtained at the level of the predefined nerves and observation sites: - Total and partial conduction block (reduction in the area and amplitude of the global muscle action potential expressed in percentage));	24 months
Secondary	Correlation between ultrasound data and electrophysiological data	The study of the correlation between the ultrasound data and the electrophysiological data will be carried out on the basis of the ultrasound scores obtained at the level of the predefined nerves and observation sites: - Reduction in the amplitude of the global muscle action potential (amplitude in mV)	24 months