Quantification of Nerve Stiffness in Neuropathies (Nerf_SSI)

Quantification of Nerve Stiffness in Patients with Peripheral Neuropathies

This project aims to understand how nerve mechanical properties are altered in patients with rare peripheral neuropathies . Stiffness of various peripheral nerves will be measured using ultrasound shear wave elastography. Patients will be compared with age-matched controls.

Study Overview

• Status: Completed
• Conditions: Chronic Inflammatory Demyelinating Polyneuropathy; Anti-MAG Neuropathy; Charcot-Marie-Tooth Disease, Type IA
• Intervention / Treatment: Other: elastography measurements

Detailed Description

The following nerve will be studied bilaterally, in a randomised order: Median, ulnar, Radial, Sciatic and Tibial.

Participants will be asked to remain relaxed during elastography measurements.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Univeristy of Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female aged 18 to 65
• Having social insurance status
• Having given informed consent
• Diagnostic of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), CMT1a or Anti-MAG (peak immunoglobulin M (IGm)>15,000 BTU)

Exclusion Criteria:

For controls:

• Person staying in a health or social facility
• Person unable to understand the protocol and to respect the modalities
• Person deprived of liberty
• Person of legal age benefiting from a system of legal protection (guardianship, curators or safeguard of justice)
• Participation in another biomedical research in progress
• Diabetes, history of neuromuscular disease

For CIDP:

• Person staying in a health or social facility
• Person unable to understand the protocol and to respect the modalities
• Person deprived of liberty
• Person of legal age benefiting from a system of legal protection (guardianship, curators or safeguard of justice)
• Participation in another biomedical research in progress
• MRC score < 3

For Charcot-Marie-Tooth type 1 (CMT1) and anti-MAG:

• Person staying in a health or social facility
• Person unable to understand the protocol and to respect the modalities
• Person deprived of liberty
• Person of legal age benefiting from a system of legal protection (guardianship, curators or safeguard of justice)
• Participation in another biomedical research in progress

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: controls	Other: elastography measurements; elastography measurements
Experimental: patients with peripheral neuropathies; This project aims to understand how nerve mechanical properties are altered in patients with rare peripheral neuropathies . Stiffness of various peripheral nerves will be measured using ultrasound shear wave elastography. Patients will be compared with age-matched controls.	Other: elastography measurements; elastography measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nerve shear wave velocity	Ultrasound shear wave elastography will provide a measure of nerve shear wave velocity, which will be used as a surrogate of nerve stiffness.	Day0

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Université de Nantes
• Investigators: Principal Investigator: Yann Pereon, PU-PH, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2018
• Primary Completion (Actual): December 8, 2023
• Study Completion (Actual): December 8, 2023

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 5, 2018
• First Posted (Actual): January 11, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Nervous System Diseases; Pathologic Processes; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Genetic Diseases, Inborn; Autoimmune Diseases; Immune System Diseases; Peripheral Nervous System Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Neurodegenerative Diseases; Congenital Abnormalities; Heredodegenerative Disorders, Nervous System; Nervous System Malformations; Polyradiculoneuropathy; Polyneuropathies; Tooth Diseases; Charcot-Marie-Tooth Disease; Nerve Compression Syndromes; Hereditary Sensory and Motor Neuropathy; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
• Other Study ID Numbers: RC17_0231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No